sop of production department
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SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE
INDEX OF PRODUCTION SOP’S Sr. No
NAME OF THE SOP
Category/ SOP No.
1.
SOP FOR PREPARATION OF SANITIZING SOLUTION
SPD/01
2.
SOP FOR RODENTS, INSECTS & BIRDS CONTROL IN PRODUCTION
SPD/02
3.
SOP FOR CLEANING AND OPERATION OF AIR HANDLING UNIT PRE FILTERS
SPD/03
4.
SOP FOR DISPOSAL OF EXPIRED FINISHED GOODS
SPD/04
5.
SOP FOR BUILDING MAINTENANCE
SPD/05
6.
SOP FOR DISPOSAL OF EXCESS/ REJECTED PACKING MATERIAL
SPD/06
7.
SOP FOR ENTRY/ EXIT OF VISITORS IN MANUFACTURING AREA
SPD/07
8.
SOP FOR ENTRY INTO PRODUCTION AREA
SPD/08
9.
SOP FOR SAFETY PRACTICES
SPD/09
10.
SOP FOR LOG BOOK SYSTEM
SPD/10
11.
SOP FOR ENVIRONMENT MONITORING
SPD/11
12.
SOP FOR REMOVAL OF SCRAP FROM PRODUCTION AREA
SPD/12
13.
SOP FOR DISPOSAL OF EMPTY CONTAINERS
SPD/13
14.
SOP FOR CLEANING OF GENERAL DRESSES
SPD/14
15.
SOP FOR CLEANING AND SANITATION OF GENERAL AREA PRODUCTION BLOCK
SPD/15
16.
SOP FOR CALIBRATION AND OPERATION OF WEIGHING BALANCE
SPD/16
17. 18.
SOP FOR CLEANING AND OPERATION OF MANUAL CAPSULE FILLING MACHINE SOP FOR CLEANING AND OPERATION OF BLISTER PACKING MACHINE
SPD/17 SPD/18
19.
SOP FOR CLEANING AND OPERATION OF DOUBLE CONE BLENDER
SPD/19
20.
SOP FOR CLEANING AND OPERATION OF DRY FILLING MACHINE
SPD/20
21.
SOP FOR CLEANING AND OPERATION OF ROPP CAP BOTTLE SEALING MACHINE
SPD/21
22.
SOP FOR DECARTONING OF CONTAINERS AND CLOSURES
SPD/22
23.
SOP FOR CONTROLLING MICROBIAL CONTAMINATION (OINTMENT SECTION)
SPD/23
24.
SOP FOR PROCEDURE FOR LINE CLEARANCE ( PACKING)
SPD/24
25.
SOP FOR VISUAL INSPECTION
SPD/25
26.
SOP FOR BATCH CODING
SPD/26
Rmk
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 27.
SOP FOR REPROCESSING OF RECOVERY
SPD/27
28.
SOP FOR LEAK TEST FOR CAPSULES/ TABLETS (STRIP AND BLISTER PACKING)
SPD/28
29.
SOP FOR CLEANING & OPERATION OF CAPSULE LOADER
SPD/29
30.
SOP FOR CLEANING & OPERATION OF DEHUMIDIFIER
SPD/30
31.
SOP FOR CLEANING & OPERATION OF STRIP PACKING MACHINE
SPD/31
32.
SOP FOR CLEANING & OPERATION OF SIFTER
SPD/32
33.
SOP FOR HANDLING OF FINISHED PRODUCTS IN STORE
SPD/33
34.
SOP FOR PACKING OPERATION
SPD/34
35.
SOP FOR CLEANING OF PASTE KETTLE
SPD/35
36. 37. 38
SOP FOR GENERAL CLEANING OF EQUIPMENT IN MANUFACTURING AREA SOP FOR ADVERSE HEALTH CONDITION OF PERSON IN MANUFACTURING AREA SOP FOR INTERNAL LABELING DURING QUARANTINE, STORAGE AND PROCESSING
SPD/36 SPD/37 SPD/38
39.
SOP FOR RECEIPT OF PACKING MATERIAL IN PRODUCTION
SPD/39
40.
SOP FOR DISPOSAL & SALVAGE OF REJECTED / EXPIRED / UNUSABLE MATERIALS
SPD/40
41.
SOP FOR THE WASTE COLLECTION FROM PRODUCTION AREA
SPD/41
42.
SOP FOR CLEANING OF CONVENTIONAL COATING PAN
SPD/42
43.
SOP FOR CLEANING OF FLUIDIZED BED DRYER
SPD/43
44.
SOP FOR CLEANING AND OPERATION OF MULTIMILL
SPD/44
45.
SOP FOR CLEANING OF POLISHING PAN
SPD/45
46.
SOP FOR CLEANING AND OPERATION OF CAPSULE FILLING MACHINE (SEMI AUTO MATIC)
SPD/46
47.
SOP FOR CLEANING OF SPRAY GUN
SPD/47
48.
SOP FOR CLEANING OF TABLET DEPARTMENT
SPD/48
49.
SOP FOR PASTE PREPARATION VESSEL
SPD/49
50.
SOP FOR DISPOSAL OPERATION IN TABLET DEPARTMENT
SPD/50
51.
SOP FOR CLEANING & ASSEMBLING OF COMPRESSION MACHINE
SPD/51
52.
SOP FOR TABLET COMPRESSION TOOLING
SPD/52
53.
SOP FOR STORAGE OF IN-PROCESS TABLETS & GRANULES
SPD/53
54.
SOP FOR OPERATION OF FLUIDIZED BED DRYER
SPD/54
55.
SOP FOR CLEANING AND OPERATION OF MASS MIXER
SPD/55
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 56.
SOP FOR TABLETS INSPECTION
SPD/56
57.
SOP FOR HOUSE KEEPING IN TABLET COMPRESSION SECTION
SPD/57
58.
SOP FOR HOUSE KEEPING IN TABLET PACKING AREA
SPD/58
59.
SOP FOR CLEANING OF MANUFACTURING VESSEL (TOPICAL SECTION)
SPD/59
60.
SOP FOR CLEANING OF BULK TANK (TOPICAL SECTION)
SPD/60
61.
SOP FOR CLEANING AND ASSEMBLING OF TUBE FILLING MACHINE (TOPICAL SECTION)
SPD/61
62.
SOP FOR POLISHING OF CAPSULES
SPD/62
63.
SOP FOR CLEANING OF S.S. WAX MELTING VESSEL (TOPICAL SECTION)
SPD/63
64.
SOP FOR POLISHING OF PUNCHES AND DIES
SPD/64
65. 66. 67.
SOP FOR CLEANING OF UTENSILS, SCRAPPER,SPOONS & SCOOPS (TOPICAL SECTION) SOP FOR REMOVAL OF BULK FROM TUBE FILLING MACHINE
SPD/65 SPD/66
(TOPICAL SECTION)
SOP FOR IN-PROCESS CONTROL IN MANUFACTURING (TOPICAL
SPD/67
SECTION)
68.
SOP FOR HOUSE KEEPING IN TOPICAL SECTION
SPD/68
69.
SOP FOR INSTALLATION OF NEW PUNCH SET
SPD/69
70.
SOP FOR IN-PROCESS PACKING ( TOPICAL SECTION)
SPD/70
71.
SOP FOR LINE CLEARANCE (TOPICAL SECTION)
SPD/71
72.
SOP FOR CLEANING OF S.S. WATER VESSEL (TOPICAL SECTION)
SPD/72
73.
SOP FOR IN-PROCESS FILL WEIGHT DETERMINATION
SPD/73
74.
SOP FOR LABELLING & PACKING OF ORAL LIQUID
SPD/74
75. SOP FOR CLEANING OF GENERAL UTENSILS, SS CONTAINERS
SPD/75
SOP FOR CLEANING OF MANUFACTUIRNG AREA (TABLET, CAPSULE &
76. LIQUID ORALS)
SOP FOR CLEANING OF S.S. CONTAINERS, PRESSURE VESSELS,
77. TANKS & STIRRER 78. SOP FOR CLEANING OF CONVEYOR BELT
S.S.
SPD/76 SPD/77 SPD/78
79. SOP FOR OPERATION & CLEANING OF BOTTLE FILLING MACHINE
SPD/79
80. SOP FOR OPERATION & CLEANING OF BOTTLE WASHING MACHINE
SPD/80
81. SOP FOR OPERATION & CLEANING OF COLLOIDAL MILL
SPD/81
82. SOP FOR OPERATION & CLEANING OF HIGH SPEED STIRRER
SPD/82
83. SOP FOR OPERATION & CLEANING OF FILTER PRESS
SPD/83
84. SOP FOR OPERATION & CLEANING OF PP CAP SEALING MACHINE
SPD/84
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 85. SOP FOR VISUAL INSPECTION OF LIQUID ORALS
SPD/85
86. SOP FOR CLEANING OF S.S. TANKS & STIRRER (LIQUID SECTION)
SPD/86
87. SOP FOR MIXING, GRANULATION & PUNCHING
SPD/87
88. SOP FOR STRIP VISUAL INSPECTION
SPD/88
SOP FOR OPERATION AND CLEANING OF TABLET COMPRESSION
89. MACHINE (ROTARY MACHINE)
SOP FOR OPERATION AND CLEANING OF TABLET COMPRESSION
90. MACHINE (MULTI PUNCHING MACHINE)
SOP FOR OPERATION OF TUBE FILLING , SEALING ,CLEANING,
SPD/89 SPD/90
91. CRIMPING & BATCH CODING MACHINE (TOPICAL SECTION) 92. SOP FOR INSPECTION, CLEANING & PACKING OF TUBES
SPD/91
93. SOP FOR BATCH DESTRUCTION
SPD/93
94. SOP FOR CLEANING & OPERATION OF PLANETARY MIXER
SPD/94
SOP FOR CLEANING, OPERATION & MAINTENANCE OF COLLOIDAL
95. MILL.
SOP FOR WASHING & CLEANING OF EQUIPMENTS (EXTERNAL
96. PREPARATION SECTION) 97. SOP FOR BATCH PREPARATION OF EXTERNAL PREPARATION
SOP FOR WASHING, CLEANING & STORAGE OF EQUIPMENT, VESSELS,
SPD/92
SPD/95 SPD/96 SPD/97
98. & STIRRER MACHINE PARTS FOR OINTMENT & CREAM. 99. SOP FOR COATING PAN
SPD/98
100. SOP FOR TRANSFER OF FINISHED GOODS TO FINISHED GOODS STORE
SPD/100
101. SOP FOR OPERATION AND CLEANING OF TRAY DRIER
SPD/101
102. SOP FOR OPERATION AND CLEANING OF ALU-ALU PACK MACHINE
SPD/102
103. SOP FOR OPERATING OF AIR COMPRESSOR
SPD/103
104. SOP FOR OVER PRINTING ON STRIPS
SPD/104
105. SOP FOR LEAKAGE CHECKS IN FILLED BOTTLE
SPD/105
106. SOP FOR OVER PRINTING ON BOXES AND LABELS
SPD/106
SPD/99
TITLE: SOP FOR PREPARATION OF SANITIZING SOLUTION Page : 01-02 Deptt.: PRODUCTION SOP NO. : SPD/01 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.……………
Sign.………………….
Sign.…………...… Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Preparation of Sanitizing Solution. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1
Preparation of Sanitizing Solution 5.1.1
70% Isopropyl Alcohol in D. M. water. Take 700ml IPA in a measuring cylinder. Add sufficient quantity of D.M.water to make 1.0-Liter solution.
5.1.2
2% Savlon solution in D.M water. Take 20ml Savlon Solution in a measuring cylinder and make 1.0 liter using DM water.
5.1.3
2% Dettol solution in D M water Take 20ml Dettol Solution in a measuring cylinder and make 1.0 liter using DM water.
5.1.4
5% Phenol solution in DM water. Heat the bottle containing Phenol in a water bath till it melts.Take 50ml liquified Phenol in a measuring cylinder and make volume up to 1.0 liters by using DM water.
TITLE: SOP FOR PREPARATION OF SANITIZING SOLUTION Page : 02-02 Deptt.: PRODUCTION SOP NO. : SPD/01 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.……………
Sign.………………….
Sign.…………...… Sign.…….……….
5.1.5
4% v/v Hydrogen Peroxide solution in Distilled water Take 40 ml Hydrogen Peroxide in a measuring cylinder and add distilled water to it to make up the volume 1.0 liters.
5.1.6
2% v/v Benzalkonium Chloride solution in Distilled water Take 20ml Benzalkonium Chloride in a measuring cylinder and add distilled water to it to make up the volume 1.0 liters.
5.1.7
2% v/v Glyceraldehyde solution in Distilled water’ Take 20ml Glyceraldehyde in a measuring cylinder and add distilled water to make volume 1.0 liters.
Note: All these preparations are prepared in third air lock. 5.2 Precaution: Wear Gloves, Mask & Goggles before preparing sanitizing solution.
TITLE: SOP FOR RODENTS, INSECTS & BIRDS CONTROL Page : 01-01 IN PRODUCTION Deptt.: PRODUCTION SOP NO.: SPD/02 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.……………
Sign.………………….
Sign.………......… Sign.…….……….
1)
PURPOSE: To lay down procedure of control of rodents, insects and birds to be carried out by the approved contractor.
2)
RESPONSIBILITY: Q.A. Manager
3)
ACCOUNTABILITY: Production Manager/ Q A Manager.
4)
SCOPE: The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE: 5.1
The approved contractor is deputing for control of birds, redents and insects by applying the chemical. Birds repellents, nets sieves repellents i.e. UV repellent (blue light), flycatcher, door nets are fixe on all entries. For insect control, company has placed at all the entry-exit place, double door, one with wire mesh, other with wooden & glass doors, with the facility of door closer.
5.2
Entries doors are installe with are Curtains to avoid entry of insects.
5.3
The contractor come twice every month or whenever called to review the situation.
TITLE: SOP FOR CLEANING & OPERATION OF AIR Page : 01-01 HANDLING UNIT PRE FILTERS Deptt.: PRODUCTION SOP NO.: SPD/03 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………..…
Sign.…………………….
Sign.………...…
Sign.…….……….
1
PURPOSE
:
2
RESPONSIBILITY
:
3
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5
PROCEDURE
:
1)
To lay down a Procedure for Cleaning and Operation of Air Handling Unit Pre-Filters. Q/C Manager.
5.1
Cleaning of pre-filter 20 micron average 7-15 days i.e. .weakly off day.
5.2
Cleaning of pre-filter cabinet is carried out side of the production area.
CLEANING: 6.1
Before cleaning of the AHU pre-filter, switch OFF the mains.
6.2 Loosen the filter cabinet bolts. 6.3 Remove the filter cabinet set aside. 6.4 Close the AHU filter cabinet with poly bag till the filter is ready to be fixed. 6.5 Clear the filter by compressed air at least for five times with airflow in reverse of the operational flow direction, out side the production area. 6.6 Wash the pre-filters using mild soap solution and then with running tap water. 6.7 Pass the compressed air through the other side of the filter and then dry the filter. 6.8 Remove the poly bag from dust. 6.9 Clean the filter cabinet with dry clothes. 6.10 Fix the pre-filter and tight cabinet bolts. 6.11 Record the cleaning operation of pre-filters in prescribed format. TITLE: SOP FOR DISPOSAL OF EXPIRED FINISHED Page : 01-01 GOODS Deptt.: PRODUCTION SOP NO.: SPD/04 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.……………….……
Sign.……………..……….
Sign.………...…
Sign.…….……….
1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
1)
To lay down a Procedure for Disposal of Expired Finished Goods. Q/C Manager.
5.1
All the finished goods are carried to the disposal area in the final packed form. Take out the inner carton from the shipper & finally take out the Tablets/ Capsules/ Oral Liquid/ Dry Syrup & Ointment from the inner cartons.
5.2
In case of Tablets/ Capsules/ Oral Liquid/ Dry Syrup & Ointment, submerge them in water to dissolve & after dissolution, dump the slurry or solution into a ditch. In case of Oral Liquid, break the seal of bottles, take out the liquid or solution into a bucket & put it into the ditch. Glass containers & seals are kept separately for sale as a waste. Shippers & inner cartons are burnt separately during packing material disposal.
5.3
The label of the labeled bottle is removed before disposal.
PRECAUTIONS : 6.1
Expired finished materials are not used for medicinal purpose.
6.2
Cartons or shipper or poly bags in which the finished materials were kept are separated before disposal of finished goods and disposed off separately.
6.3
Disposal done under supervision of Q.A. Head.
6.4
Poisonous or obnoxious materials are treated to neutralization before dumping.
6.5
After disposal of the material, the same is recorded.
TITLE: SOP FOR BUILDING MAINTENANCE
Page : 01-02 Deptt.: PRODUCTION SOP NO.: SPD/05 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.……………
Sign.………………….
Sign.………...…
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Building Maintenance.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1
The factory maintenance is an important part of maintaining facilities to work smoothly and hygienically and periodically maintained by repairing, painting, washing, moping etc.
5.2
MAINTENANCE REQUIRED : The following categories of the maintenance are generally required in a Pharmaceutical formulation plant. 5.2.1
Civil Maintenance
5.2.2
Electrical Maintenance
5.2.3
Utilities Maintenance
The above categories are further classified as under to decentralize the work according to need. 5.2.1 CIVIL MAINTENANCE: This includes the following parts of maintenance in a building. 5.2.1.1
Repairs of walls and floors with plastering work.
5.2.1.2
Parts on walls and other places where ever required.
5.2.1.3
Aluminum or glass work required for doors and windows.
5.2.1.4
External roads linked with the Production premises.
5.2.1.5
Insects/ Rodents protective mesh where ever provided.
TITLE: SOP FOR BUILDING MAINTENANCE
Page : 02-02 Deptt.: PRODUCTION SOP NO.: SPD/05 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.……………
Sign.………………….
Sign.…………...
Sign.…….……….
5.2.2. ELECTRICAL MAINTENANCE: 5.2.2.1
Exhaust fans, Fans, Air Conditioners.
5.2.2.2
Tube lights, Insect repeller, Air curtain.
5.2.2.3
General wiring of Production premises and electrical points.
5.2.2.4
Electrical water purification system where ever applicable.
5.2.2.5
Major electrical panels.
5.2.3 UTILITIES MAINTENANCE:
1)
5.2.3.1
Cleaning and maintenance of water distribution system.
5.2.3.2
Maintenance of drainage system, sinks, taps, pipes.
5.2.3.3
Maintenance of air cooling system.
5.2.3.4
Maintenance of effluent treatment plant.
5.2.3.5
Generator system and transformer.
5.2.3.6
Lawns and plantation maintenance.
FREQUENCY 6.1
All major repairs of production premises: Once in 6 months.
6.2
Paints: Once in 6 months in those areas where repair has been done. Once in a year for the complete plant & factory.
2)
6.3
For Doors and glass work: Once in 2 months.
6.4
For wire mesh: Once in 6 months.
6.5
For external roads: Once in a year.
MAINTENANCE PROCEDURE: 7.1
The maintenance carried out when the production is not going on.
7.2
All electrical maintenance work to be done by an expert under the supervision of Company’s Electrical Engineer.
7.3
All repairs are carried out on request of the concerned Department Head in writing and approval by the above referred authorized persons.
7.4
Records and log for all such repairs are maintained.
TITLE: SOP FOR DISPOSAL OF EXCESS / REJECTED Page : 01-01 PACKING MATERIAL Deptt.: PRODUCTION SOP NO.: SPD/06 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………..…
Sign.……….…………….
Sign.………...…
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Disposal of Excess / Rejected Packing Material. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1
After completion of packing operation of one batch product, the packing line is checked for excess packing materials.
5.2
Excess P.M. sorted out and good / without printed packing materials is counted and tied.
5.3
All good material are returned to packing material store through material return note.
5.4
All coded unit cartons/labels are transferred to scrap yard and shredded into pieces before disposing off.
5.5
Details of all returned materials and rejected materials are recorded in packing material reconciliation sheet included in Batch Production Record.
TITLE: SOP FOR ENTRY/EXIT OF VISITORS IN Page : 01-01 MANUFACTURING AREA Deptt.: PRODUCTION SOP NO.: SPD/07 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.………………….…
Sign.…………………….
Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Entry / Exit of Visitors in Manufacturing Area. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. Entry of Visitors: -
5.1
Entry of visitor to these Areas is restricted as much as possible.
5.2
Entry of visitors is given a clean lab coat, cap & mask.
5.3
Then visitors & accompanying authorized person put ‘shoe cover’ on his street shoes or wear clean laboratory sleepers. They cross the barrier before entering manufacturing area. After which they are dip the footwear’s in to the disinfecting solution soaked mat and then into the main working area.
5.4
Before leaving the manufacturing area visitor remove the shoe cover, lab coat, cap & mask and the concerned officer send them for washing.
TITLE: SOP FOR ENTRY INTO PRODUCTION AREA
Page : 01-01 Deptt.: PRODUCTION SOP NO.: SPD/08 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.……………
Sign.………………….
Sign.………...…
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Entry into Production Area.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. Before entering into any area the following norms are followed: -
5.1
Wash and dry their hands.
5.2
Wear clean factory uniform, head covers, gloves, masks and foot-covers where necessary.
5.3
Workman wears head cover, facemask in such a way that the whole head, hair, moustaches and beards are covered so that particles on the hair do not contaminate the working areas.
5.4
Outside visitors when taken for a round in the operational areas should wear aprons, head-covers and foot-covers as per the requirement.
5.5
Before changing into factory uniforms, items of jewellary is removed and kept in the lockers provided.
5.6
No food or drink is carried in the production areas.
5.7
Do not eat; chew tobacco, pan or betel nuts while working.
5.8
Smoking is strictly prohibited in the production areas/ office premises.
5.9
Nails are trimmed frequently.
5.10
Use of cosmetics and perfumes are avoided as far as possible.
TITLE: SOP FOR SAFETY PRACTICES SOP NO.: SPD/09 Effective Date: 15-07-2007 Revision No.: Prepared by: Checked By:
Page : 01-01 Deptt.: PRODUCTION Review Date: 14-07-2009 Approved By
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Asstt. Production Chemist
Production Manager
Q.A. Manager
Sign.…………………….… Sign.………………………. Sign.………...…
Director Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Safety Practices.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1 Hand gloves and safety shoes are used in the manufacturing area. Enough, gloves, etc. are available and used when required.
5.2 Lighting and electrical fittings are flame proof. In case of hot work, there is a system to issue welding and fire permit (spark generating maintenance activity).
5.3 All safety precautions are adopted according to the needs.
TITLE: SOP FOR LOG BOOK SYSTEM
Page : 01-02 Deptt.: PRODUCTION SOP NO.: SPD/10 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.………...…
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Log Book System.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. FORMAT: Log-book is maintained depending upon the user department, the log book should contain the following details:
5.1
5.2
Equipment: a)
Name of Equipment.
b)
Code No.
c)
Product & its batch number.
d)
Remarks, if any
e)
Signature of chemist and Signature of the person checking.
Lab Instrument: a)
Instrument Name
b)
Sr. No.
c)
Date of Analysis
d)
Analysis time
e) number
Product analyzed & its batch
f)
A.R. No.
g)
Remarks of Analysis if any
h)
Signature Signature of the person checking the analysis report.
TITLE: SOP FOR LOG BOOK SYSTEM
of
analyst
Page : 02-02 Deptt.: PRODUCTION SOP NO.: SPD/10 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
and
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.………...… 5.3
5.4
Sign.…….……….
Chemist / Analyst’s Log Book: a)
Date of analysis
b)
Name of the test, analysis data and calculation details.
c)
Product analyzed & its batch number
d)
Signature of analyst and Signature of the person checking the analysis.
Calibration Log Books: a)
Instrument Name
b)
Range
c)
Accuracy
d)
The standard used
e)
Calibration Frequency
f)
Model No.
g)
Signature of person calibrating the equipment / instrument and Signature of the person reviewing the calibration report.
Note: If any instrument is malfunctioning or requires non-routine maintenance, work order should be generated by the Analyst / Chemist responsible for calibration of that instrument and maintenance details to be entered in instrument log book / chemist log book.
Equipment / Instrument Name
Service required data
Data repaired
Nature of repair work carried out in detail
Re-calibration data
Signature of chemist and date
TITLE: SOP FOR ENVIRONMENT MONITORING SOP NO.: SPD/11 Effective Date: 15-07-2007 Revision No.: Prepared by: Checked By:
Page : 01-03 Deptt.: PRODUCTION Review Date: 14-07-2009 Approved By
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Asstt. Production Chemist
Production Manager
Q.A. Manager
Sign.…………………….… Sign.………………………. Sign.………...…
Director Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Environment Monitoring.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1
Record the temperature & humidity in the environment monitoring chart.
5.2
Regulate the A/C of Dehumidifier if the temperature of a particular area is the out of the prescribed limit.
5.3
The limit is specified below:
Area
Temperature
Humidity
Mixing Granulation & Drying
28-29O C
70% Max.
Blending, Compression
25-27O C
40-45%
Capsulation, Powder, Dry Syrup
23-25O C
40-45%
Beta-Lactum Capsules, Tablets
23-27O C
40-45%
Film Coating
25-27O C
50-55%
Corridors
25-27O C
70% Max
TITLE: SOP FOR ENVIRONMENT MONITORING SOP NO.: SPD/11 Effective Date: 15-07-2007 Revision No.: Prepared by: Checked By:
Page : 02-03 Deptt.: PRODUCTION Review Date: 14-07-2009 Approved By
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Asstt. Production Chemist
Production Manager
Q.A. Manager
Sign.…………………….… Sign.………………………. Sign.………...… (a)
(b)
Director Sign.…….……….
Store area for •
Beta Lactum
25-27O C
50% Max
•
Capsules & Sensitive Materials
25-27O C
50% Max
•
Other products
30O C
70% Max
Instrument room & Microbiology room
25-27O C
50% Max
Chemical Laboratory
28-30O C
70% Max
Quarantine & Control Sample Room
25-27O C
50% Max
Liquid Mfg. & Bottle Washing
28-29O C
70% Max
Ointment & Lotions
25-27O C
50-55%
Laboratory
TITLE: SOP FOR ENVIRONMENT MONITORING SOP NO.: SPD/11 Effective Date: 15-07-2007 Revision No.: Prepared by: Checked By:
Page : 03-03 Deptt.: PRODUCTION Review Date: 14-07-2009 Approved By
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Asstt. Production Chemist
Production Manager
Q.A. Manager
Sign.…………………….… Sign.………………………. Sign.………...… 1. Date
Area
Director Sign.…….……….
Record the result in the following format Time
Limit
Observation
Remarks
TITLE: SOP FOR REMOVAL OF SCRAP FROM PRODUCTION Page : 01-01 AREA Deptt.: PRODUCTION SOP NO.: SPD/12 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.………...…
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Removal of Scrap form Production Area. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1
All the scraps are collected in a polythene lined dust bin.
5.2
All scarp filled polythene bags in dustbin are taken to scrap dumping area.
6)
PRECAUTIONS:
6.1
All scraps must be checked by House keeping Supervisor to ensure that no printed packing material container or machine parts reach at the backyard.
TITLE: SOP FOR DISPOSAL OF EMPTY CONTAINERS
Page : 01-01 Deptt.: PRODUCTION SOP NO.: SPD/13 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.………...…
Sign.…….……….
1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1
5.2
5.3
To lay down a Procedure for Disposal of Empty Containers. Q/C Manager.
CORRUGATED BOXES 5.1.1
Ensure that the boxes/ containers are empty.
5.1.2
Fold the boxes, stuck and tie them.
5.1.3
Transfer them to scrap yard.
METALLIC CONTAINERS 5.2.1
Wash all the containers with sufficient quantity of tap water.
5.2.2
Transfer the containers to scrap yard.
GLASS CONTAINERS 5.3.1
The glass scarp is sorted out in the Scarp Yard.
5.3.2
Containers are property checked for any left out material.
5.3.3
Cross mark on label of the corrugated box with black marking pan.
5.3.4
Do not use empty containers for storage of any other material.
5.3.5
Destroy the containers containing hazardous / corrosive material in presence of warehouse supervisor.
TITLE: SOP FOR CLEANING OF GENERAL DRESSES
Page : 01-02 Deptt.: PRODUCTION SOP NO.: SPD/14 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.………...… : :
Sign.…….……….
1) 2)
PURPOSE RESPONSIBILITY
To lay down a Procedure for Cleaning of General Dresses. Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. All the dresses are cleaned at a single place under the supervision of the above-specified competent personnel.
5.1
The collected dresses are further categorized as per their color and utilization and properly recorded in the log book available with the house keeping department.
5.2
All the unclean dresses are then segregated as per their color and use and entered in the log book prior to given for washing.
1)
CLEANING PROCEDURE : 6.1
The unclean dresses are washed by the washerman; he is instructed to wash colored and white dresses separately to avoid coloration of the white dresses.
6.2
The dresses are first observed for any oil spot or other chemicals to be removed with solvent namely IPA / Ethanol, prior to washing.
6.3
The above treated dresses are then dipped in a soap solution at a temperature between 40 to 45OC and rotated for 30 to 35 minutes.
TITLE: SOP FOR CLEANING OF GENERAL DRESSES
Page : 02-02 Deptt.: PRODUCTION SOP NO.: SPD/14 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.………...…
Sign.…….……….
6.4
The above treated dresses are then squeezed and dipped in a drum of fresh water and again rotated for 30 minutes and with another change of fresh water these are placed for spinning stage.
6.5
Drying of the washed dresses are carried either by centrifugal method of by drying in a current of warm air. Drying in direct sunlight is strictly avoided.
6.6
After complete drying of the dresses it goes under ironing.
6.7
The dresses are daily cleaning as per the above procedure.
6.8
All the cleaned dresses are then received and recorded in the Logbook.
6.9
The cleaned dresses are then segregated as per their colour and requirements and kept in the appropriate cupboard making entry in the logbook.
6.10
The above cycle is continuously monitored and dresses are issued to each department by Signing in the logbook.
6.11
The change in the above process is validated by the concerned Department / Personnel only.
TITLE: SOP FOR CLEANING AND SANITATION OF Page : 01-03 GENERAL AREA PRODUCTION BLOCK Deptt.: PRODUCTION SOP NO.: SPD/15 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.………...…
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Removal of Scrap form Production Area. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
5)
FREQUENCY
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. Daily Schedule.
6)
PROCEDURE
:
6.1
Pick up the trace materials from floors.
6.2
Empty waste bins and reline with plastic bags when necessary.
6.3
Wash sink and waste pipe using 0.1% Teepol solution in water and wipe dry.
6.4
Wash interior surface of commode bowl using bowl cleaner solution with a bowl mop. Wash exterior surface of bowl seat using 0.1% Teepol solution in water.
6.5
Damp mop all accessible are using lint free or rubber lined handle mops initially with a 0.1% Teepol solution in water then with plain water and finally with a disinfectant solution. Bucket 1 – To squeeze out the dirty water from mop. Bucket 2- To Contain clean water for rinsing the mop.
6.6
Use two bucket system.
6.7
Dispose off the used water promptly.
6.8
Allow the floor to dry up.
6.9
Flush out the drainage channel after removing any solid debris.
TITLE: SOP FOR CLEANING AND SANITATION OF Page : 02-03 GENERAL AREA PRODUCTION BLOCK Deptt.: PRODUCTION SOP NO.: SPD/15 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.………...…
Sign.…….……….
6.10
Wipe the surrounding area with a mop soaked in disinfectant solution.
6.11
Wash hands before carrying out any other activities.
6.12
Rotate the disinfectant to be used on daily basis and record the same in daily cleaning.
6.13
Mop up any spillages as soon as it occurs.
6.14
Carryout the cleaning operation as and when necessary to ensure the aera as clean and hygienic.
6.15
Fill the daily cleaning and sanitation record and get it Signed.
Weekly Schedule: 1. Clean the wall using sponge impregnated with 0.1% Teepol solution in water. 2. Wipe down the handrails, stairways with an approved disinfectant solution. 3. Dedust all the shelves, floors and walls of change rooms, the storage and weighting area using a sponge. 4. Damp wipe all surfaces with 0.1% Teepol solutions in water after moving out any movable equipment such as container, weighing balance. 5. Damp wipe the accessible parts of intercom with sponge or cloth. 6. Damp wipe the doors, push plates, view panels and glasses with a spray of aerosols cleaner (Colin) and wipe dry. 7. Dedust exhaust fan, light fixer with sponge or cloth. 8. Damp wipe all other fixer with a sponge or cloth using 0.1% Teepol solution in water. 9. Hose down the passages with plenty of water. Flush out the water. TITLE: SOP FOR CLEANING AND SANITATION OF Page : 03-03 GENERAL AREA PRODUCTION BLOCK Deptt.: PRODUCTION SOP NO.: SPD/15 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.………...…
Sign.…….……….
Monthly Schedule 1)
Wash waste bin with a disinfectant solution.
2)
Apply the floor finish on clean and dry floor and rub it to polish.
3)
Clean wipe the light diffuser and U.V. Light tube with a wet cloth.
4)
Clean wipe the light switches with I.P.A.
TITLE: SOP FOR CALIBRATION AND OPERATION OF WEIGHING BALANCE SOP No.: SPD/16 Effective Date: 15-07-2007 Revision No.: Prepared by: Checked By:
Page : 01-02 Deptt.: PRODUCTION Review Date: 14-07-2009 Approved By
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Asstt. Production Chemist
Production Manager
Q.A. Manager
Sign.…………………….… Sign.………………………. Sign.…………...
Director Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Calibration and Operation of Weighing Balance. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
6)
CALIBRATION : 6.1
Switch off the electric supply to the balance, in case of an electric balance.
6.2
Clean the pan/ platform of the balance with a brush. If required cleaning is done with clean cloth dipped in 0.1% Teepol solution followed by clean water.
6.3
Check the level of balance and ensure that the balance is properly leveled.
6.4
Select the standard weights for various weighing balance based upon the capacity of balance to be calibrated.
6.5
In case of electronic balance switch “ON” the balance, adjust the balance whether electronic or mechanical to zero. Place standard weight s one by one on the platform/ pan. Record the rading in respect calibration record. These records are available at weighing station.
6.6
Check that the observed weights are within the limits, as given in this SOP.
6.7
If the error is more than acceptable limits, the error is rectified before the balance is to be used.
6.8
Do not use the balance if the error is not rectified. Inform the Production Executive and call the Service Engineer. Balance Capacity 200 gm 6 kg 60 kg 100 kg
Standard Weight 1.00 gm 400 gm 5 kg. 5 kg.
Standard Weight 10 gm 5 kg. 10 kg. 50 kg.
Acceptable Limit +0.1 % max. +0.25% max. +0.25% max. +0.25% max.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE TITLE: SOP FOR CALIBRATION AND OPERATION OF Page : 02-02 WEIGHING BALANCE Deptt.: PRODUCTION SOP No.: SPD/16 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Checked By: Approved By Prepared by: Production Manager Asstt. Production Chemist Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 6.9 7.0
Sign.…….……….
Selection of standard weights for interpretation of data is given below :-
OPERATION:7.1
In case of electronic balance, switch “OFF” electric supply to the balance.
7.2
Clean the pan of the balance with brush. If required, Teepol solution 0.1% followed by D.M. water and wipe dry with clean cloth.
7.3
Level the balance property.
7.4
Keep pallets and stainless steel containers near the balance.
7.5
In case of electronic balance, switch “ON” the power supply.
7.6
In case of electronic balance, press the “ON” switch on the digital control and wait till it indicates ZERO. In case of mechanical balance check ZERO reading.
7.7
Balance set to zero, if any error is observed.
7.8
Place the material on the balance platform / pan by one and check. Check the weights against requisition slip and batch production record.
7.9
Material tags are tally with the details on Batch Production Record. Checks tally the name of material, A.R. No., gross weight, tare weight and net weight of material.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE TITLE: SOP FOR CLEANING AND OPERATION OF MANUAL Page : 01-02 CAPSULE FILLING MACHINE Deptt.: PRODUCTION SOP No.: SPD/17 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1)
To lay down a Procedure for Cleaning and Operation of Manual Capsule Filling Machine. Q/C Manager.
CLEANING : 5.1.1
Loosen the bolt of the capsule filling machine.
5.1.2
Dismantle all the supporting plates & lock plates from the machine dip in water.
and
5.1.3
Remove the powder from the machine by the Nylon brush. Transfer all parts to washing area. First clean with 0.1% Teepol solution or equivalent soap solution by moping with non woven cloth.
5.1.4
Wash the machine with raw water.
5.1.5
Rinse with DM water.
5.1.6
Dry the machine.
5.1.7
Send a wash water sample for analysis of previous product to Q/A, Q/C Department.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE TITLE: SOP FOR CLEANING AND OPERATION OF MANUAL Page : 02-02 CAPSULE FILLING MACHINE Deptt.: PRODUCTION SOP No.: SPD/17 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 5.2)
Sign.…….……….
OPERATION:5.1.1
After receiving the QC report fix a label. “READY FOR USE”.
5.1.2
After getting QC report, reassemble the capsule machine for filling of next batch (Product).
5.1.3
Fix the Guide Plate on the machine.
5.1.4
Weigh qty. of powder to be filled for 300 capsules. Put the powder on the capsule magazine, spray the powder by a plastic made spreader.
5.1.5
Press the top plate on filled magazine.
5.1.6
Load the caps part of the capsules, and lock the plate by pressing with handle.
5.1.7
Loosen the lock bolt, remove the filled capsules.
5.1.8
Continue the same process, till the batch is finished.
5.1.9
Record the machine cleaning / operation in record. Format.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE TITLE: SOP FOR CLEANING AND OPERATION OF BLISTER Page : 01-02 PACKING MACHINE Deptt.: PRODUCTION SOP No.: SPD/18 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Cleaning and Operation of Blister Packing Machine. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. CLEANING
5.1
Switch OFF the mains.
5.2
Clean the blister packing machine with Teepol solution (0.1%) or eq. soap solution by nylon cloth / foam.
5.3
Remove the blister forming roller, ink device, hopper, chute, channel, plate ,sealing roller etc.
5.4
Clean them with Teepol solution (0.1%) or eq. soap solution by nylon cloth / foam.
5.5
Rinse with raw water, and finally with DM Water.
5.6
Clean the conveyor belt with the Teepol solution (0.1%) or eq. soap solution by nylon cloth / foam.
5.7
Rinse with raw water, and then rinse with DM Water.
5.8
Close the valve of compressed air, raw water supply line.
5.9
Proper oiling and greasing in the machine are necessary before installation of machine.
5.10
After drying, reassemble the machine.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE TITLE: SOP FOR CLEANING AND OPERATION OF Page : 02-02 BLISTER PACKING MACHINE Deptt.: PRODUCTION SOP No.: SPD/18 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
6. OPERATION : 6.1 Before the starting of the machine check the sealing roller, forming rolls, guide track, chute, hopper etc. 6.2 Open the valve of compressed air and raw water. 6.3 Fill the ink pot with the ink, and fix the stores. 6.4 Start the temperature heating element and roller forming switch. 6.5 When temperature reaches at approx. 160OC, fix the blister/ PVC roll and printed aluminum foil of the required product. 6.6 Now start the machine to check the forming cavity and sealing of blister strip. 6.7 Load the hopper with tablets/ capsules for commercial packing. 6.8 Check the sealing by Leak Test method.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE TITLE: SOP FOR CLEANING AND OPERATION OF Page : 01-02 DOUBLE CONE BLENDER Deptt.: PRODUCTION SOP No.: SPD/19 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Cleaning and Operation of Double Cone Blender. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. CLEANING:
5.1
Switch OFF the mains of Cone Blender.
5.2
Loosen the bolt/ clamp of the cone blender.
5.3
Remove the gasket and top of the mouth from the cone blender, dip in a soap or Teepol solution (0.05%).
5.4
Clean the cone blender with 0.1% Teepol solution by moping with non woven cloth.
5.5
Rinse with raw water, finally clean with DM Water.
5.6
Mop the external parts of the cone blender/ frames by the non woven cloth.
5.7
After complete cleaning of cone blender send wash water sample for analysis.
TITLE: SOP FOR CLEANING AND OPERATION OF
Page : 02-02
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE DOUBLE CONE BLENDER Deptt.: PRODUCTION SOP No.: SPD/19 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 6.
Sign.…….……….
OPERATION:6.1
After getting the wash water report, fix a label “MACHINE IS READY FOR USE”.
6.2
Switch “ON” the mains.
6.3
Add the batch (Powder) for mixing.
6.4
Close the top lid, fitted with gasket.
6.5
Tight the bolts/ clamps.
6.6
Start the machine for mixing
CAUTION: – Before starting of the machine, keep distance at least 3 ft. from the machine to avoid the accident.
TITLE: SOP FOR CLEANING AND OPERATION OF DRY
Page : 01-02
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE FILLING MACHINE Deptt.: PRODUCTION SOP No.: SPD/20 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1)
To lay down a Procedure for Cleaning and Operation of Dry Filling Macnine. Q/C Manager.
CLEANING:5.1.1
Switch OFF the mains.
5.1.2
Loosen the bolt, remove the lock of hopper of dry syrup filing machine.
5.1.3
Dismantle the auger & nozzle.
5.1.4
Loose the weight variation adjustment lock.
5.1.5
Dip all the dismantled parts in 0.1% Teepol solution.
5.1.6
Mop the dismantled parts by non woven cloth.
5.1.7
Rinse with raw water till frothing is removed.
5.1.8
Clean the external machine parts and body with DM Water by wet moping and dry the machine.
5.1.9
Finally rinse with DM Water and send a sample of wash water to the Q.A. department.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE TITLE: SOP FOR CLEANING AND OPERATION OF DRY Page : 02-02 FILLING MACHINE Deptt.: PRODUCTION SOP No.: SPD/20 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
5.2)
Sign.…….……….
OPERATION 5.2.1
After getting the result form Q.A. department fix a label “MACHINE IS READY FOR USE”.
5.2.2
Reassemble all the dismantled parts of the machine i.e. auger, weight wheel, hopper etc.
5.2.3
Add the powder/ granules of next batch; switch “ON” the mains.
5.2.4
Start the machine and check the weight of fixed quantity of each bottle.
5.2.5
Check the adjusted weight for at least 10 bottles of dry syrup.
5.2.6
Now start the production till the batch is finished.
5.2.7
Checking of weight variation of filled dry syrup bottles is done after every 30 minutes.
5.2.8
Record pertaining to cleaning, operation and weight variation is recorded in format.
TITLE: SOP FOR CLEANING AND OPERATION OF ROPP
Page : 01-01
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE CAP BOTTLE SEALING MACHINE Deptt.: PRODUCTION SOP No.: SPD/21 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1
CLEANING:5.1.1
Switch OFF the mains.
5.1.2
Clean he machine with Teepol solution (0.1%) or eq. soap solution.
5.1.3
Dismantle the sealing die. Clean with the dry cloth dipped in diesel to avoid the rust from environment.
5.1.4 5.1.5
Clean the footrest with dry cloth by moping. Apply the grease / Lubricant oil to the axle of the footrest and lever of sealing die guide.
5.1.6 5.2
To lay down a Procedure for Cleaning and Operation of R.O.P.P. Cap Bottle Sealing Machine. Q/C Manager.
Reassemble the die. Finally clean the machine with dry cloth.
OPERATION:5.2.1
Adjust the height of bottle with ROPP cap dry inching method.
5.2.2
Check the sealing of 10 dry syrup bottles for good quality of sealing.
5.2.3
Adjust the guide of the bottle pressing plate / lifting plate with sealing die.
5.2.4
Now start the production till the batch is finished.
5.2.5
Record the total cleaning and operation in record book format.
TITLE: SOP FOR DECARTONING OF CONTAINERS AND
Page : 01-01
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE CLOSURES Deptt.: PRODUCTION SOP No.: SPD/22 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1
To lay down a Procedure for Decartoning of Containers and Clousres. Q/C Manager.
General Rules :
5.1.1
All filling materials must be requested from the warehouse well in advance. These are supplied in their shipping boxes or shrink wrapped trays. No shipping box is slowed in clean area.
5.1.2
All excess material supplied which is not used is returned to warehouse. No unnecessary material is allowed to accumulate in clean area.
5.1.3
Tearing off paper in the clean area is not permitted.
5.1.4
All wastage is deposited in the dustbins provided.
TITLE: SOP FOR CONTROLLING MICROBIAL
Page : 01-01
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE CONTAMINATION (OINTMENT SECTION) Deptt.: PRODUCTION SOP No.: SPD/23 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. Controlling Microbial Contamination:- Producing product of 100% efficacy by adopting following procedures:
a)
b)
c)
To lay down a Procedure for Controlling Microbial Contamination (Ointment Section). Q/C Manager.
Compounding room cleans up:
Moping the floor and working table with hot 0.1% Teepol solution
Rinse the floor and working table with hot water.
Keep personnel traffic to a minimum.
Compounding equipment cleans up:
It is done just after completion of current batch
Clean the melting and compounding vessel with hot 0.1% Teepol solution.
Scrub the vessel, cover, agitator, scrapper with nylon scrubber to remover trace of the pervious product.
Disassemble the other equipment which comes in to content with product and clean with hot 0.1% Teepol solution and rinse with DM water and sanitize with 70% IPA.
If manufacturing equipment is stored for more than three days it must be resanitize before Use.
Filling equipment clean up and sanitization:
Dissemble all parts that come in contact with product.
Scrub all contact parts with 0.1% hot Teepol solution
Now finally rinse with DM water
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE TITLE: SOP FOR LINE CLEARANCE (PACKING)
Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/24 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Line Clearance (Packing).
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1 Packing line is cleared after every product changeover. 5.2 All unpacked goods are packed in one container and properly labeled. It is send to quarantine for storage till next packing schedule. 5.3 All rejected goods, if recoverable, are properly labeled and send to recovery quarantine. 5.4 All intact packing materials, boxes, shipper carton, labels are properly counted and tied and returned to packing store. 5.5 All torn / rejected packing material and rejected goods are shifted to scrap yard in a polythene bag for disposal. 5.6 The finished goods are accounted for and transferred to Finished Goods stores along with finished good transfer slip. 5.7 The packing belt / tables are cleaned both from top and floor and waste is collected in dust bin. 5.8 The packing area/ belt/ table are cleaned and mopped before starting packing of next product / batch. 5.9 Production Manager / Q.A. Manager jointly conduct line clearance operation. 5.10
Line clearance operation is recorded in prescribed format and duly signed by Q.A. Manager/ Production Manager.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE TITLE: SOP FOR VISUAL INSPECTION
Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/25 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Visual Inspection.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1
Test and release filled bottle of the product received from quarantine area to visual inspection area.
5.2
Depute the visual inspection team for proper checking of fiber / glass / black white particles and any foreign matter.
5.3
Check the proper sealing of bottle.
5.4
The complete visual inspection team is divided into 2 group of expert team.
5.5
Visual inspection is done by unaided naked eye.
5.6
The percentage of rejection found is to be recorded in flow sheet and register.
5.7
The visual inspection team personnel are needed maintained accordingly to ensure the proper checking of foreign matter.
5.8
Rotation gap between one group to other group is two hourly.
5.9
Finally calculate the percentage of rejection of complete batch and transfer to packing department with details bearing product name, B. No. Size, D/M, D/E.
TITLE: SOP FOR BATCH CODING
Page : 01-01
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Deptt.: PRODUCTION SOP No.: SPD/26 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Cleaning and Operation of R.O.P.P. Cap Bottle Sealing Machine. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. All the dosage forms are properly categorized with different codes explaining the details of each individual batch which is prepared and approved by the authorized personnel only.
A.
Name of the authorized personnel
B.
Details of the dosage forms for which batch coding requires.
C.
B1
Capsules/ Tablets
B2
Dry Syrup
B3
Topical Creams and Ointment.
Procedure of batch coding. D1
Batch Code have minimum 3-4 digits.
D2
1st and 2nd place are denote product code as per attached list e.g.
D3
3rd and 4th place are denote serial No. of batch e.g. 02 denotes 2 nd batch of the year of that particular product.
TITLE: SOP FOR REPROCESSING OF RECOVERY
Page : 01-01 Deptt.: PRODUCTION
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE SOP No.: SPD/27 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Reprocessing of Recovery.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1
The recoverable bottle of the different batches are collected and reported in new flow sheet with a batch no., batch size and expiry date must be mentioned of the first batch of recovery.
5.2
The bottle are collected and transferred in a clean area and reopened and solution is collected in a S.S. closed container.
5.3
Nitrogen flushing of the recovered solution is done till the batch is filled.
5.4
Recovered bulk solution is sent for testing to check the pH, assay and other tests as required.
5.5
After getting the approval from the Q.A. Department – recovered solution is filtered through sterile membrane filter in a sterile filling vessel.
5.6
Filtered solution is filled as a new batch and new Batch No. M/D, E/D, is mentioned in each and every stage.
5.7
The expiry of the new batch is the expiry of the oldest recorded batch.
5.8
Recovery details are to be recorded in the presented format of the Batch Record.
TITLE: SOP FOR LEAK TEST FOR CAPSULES/TABLETS (STRIP AND BLISTER PACKING) SOP No.: SPD/28 Effective Date: 15-07-2007 Revision No.:
Page : 01-02 Deptt.: PRODUCTION Review Date: 14-07-2009
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Prepared by: Asstt. Production Chemist
Checked By: Production Manager
Approved By Q.A. Manager Director
Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Leak Test for Capsules / Tablets (Strip and Blister Packing). Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1
A sample of 4 strips (pr equivalent to 40 pockets, whichever is higher) to be collected from the machine at the time of start up and then at an interval of 1 hours.
5.2
Place the sample into a vacuum dessicator containing enough water to cover the sample with at least one inch of water (measured from the top surface of package). Use a metal grid or screen to hold the sample submerged.
5.3
Close the dessicator and slowly apply 10 inches (25 cm) of vacuum as read on a vacuum gauge, taking between 30 seconds and one minute to raise the vacuum. Hold under vacuum for 3 minutes. Present the vacuum line for 10 inches of vacuum by means of valve.
5.4
Slowly release the vacuum and remove the samples.
5.5
Carefully dry the samples with tissue paper or soft cloth.
TITLE: SOP FOR LEAK TEST FOR CAPSULES/TABLETS (STRIP AND BLISTER PACKING)
Page : 02-02 Deptt.: PRODUCTION
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE SOP No.: SPD/28 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
5.6
Examine all pockets for evidence of leakage, i.e. water.
5.7
If one pocket shows evidence of leakage, reject the sample, stop the line, and immediately notify the packing line supervisor so that corrective action may be taken.
5.8
After adjustment of the sealing machine, select another representative set of samples, and repeat the leak test. If no leakage is detected, the line may be restarted. If leakage of any sample is still evident, adjust the machine and perform re-testing until the process is demonstrated to be under control.
5.9
Record the results of all tests in the packing record, indicating the time tested, the sample size, the number of leaking samples, found, the corrective action taken and the result of further testing.
TITLE: SOP FOR CLEANING & OPERATION OF CAPSULE LOADER MACHINE
Page : 01-03 Deptt.: PRODUCTION
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE SOP No.: SPD/29 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. FOR PRODUCT TO PRODUCT CHANGEOVER:
1.
To lay down a Procedure for Cleaning and Operation of Capsule Loader Machine. Q/C Manager.
Dedusting external surfaces:-
Use clean nylon brush and wipe with clean dry lint free duster.
2.
3.
Dismantling Remove:-
(a)
Back and front cover.
(b)
Empty capsule hopper.
(c)
Magazine followed by pusher plate and raceway.
Cleaning of parts:Clean the above parts by washing with 0.1% Teepol solution and scrubbing with soft nylon brush. Rinse with jet of potable water followed by rinsing with D.M. water. Clean loading platform with wet duster. Clean back and front cover and empty capsules hopper using clean dry lint free duster.
TITLE: SOP FOR CLEANING & OPERATION OF CAPSULE LOADER MACHINE SOP No.: SPD/29 Effective Date: 15-07-2007 Revision No.:
Page : 02-03 Deptt.: PRODUCTION Review Date: 14-07-2009
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Prepared by: Asstt. Production Chemist
Checked By: Production Manager
Approved By Q.A. Manager Director
Sign.…………………….… Sign.………………………. Sign.…………... 4.
Sign.…….……….
Drying:The cleaned parts as mentioned in step 3 are wiped and dried using clean dry lint free duster.
5.
Assembling:Reassemble all the parts of the machine carefully checking the correctness of assembling.
Note:
6.
5.1
Fix the ‘cleaned’ label.
5.2
If the cleaned loader is not used within 24 hours after cleaning or there are sign of dust or powder settled on loader, then wipe the body by using a freshly laundered lint free duster.
PROCEDURE FOR BATCH TO BATCH CHANGEOVER:6.1
Empty out the hopper.
6.2
Remove back and front cover.
6.3
Remove empty capsules from loading platform by bursh.
6.4
Dry-clean the loader with clean dry lint free duster.
CAUTION: In case of any abnormal sound from machine during its operation, stop the machine and report to maintenance.
TITLE: SOP FOR CLEANING & OPERATION OF CAPSULE LOADER MACHINE SOP No.: SPD/29 Effective Date: 15-07-2007 Revision No.: Prepared by: Checked By:
Page : 03-03 Deptt.: PRODUCTION Review Date: 14-07-2009 Approved By
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Asstt. Production Chemist
Production Manager
Q.A. Manager
Sign.…………………….… Sign.………………………. Sign.…………... 7.
8.
9.
10.
Director Sign.…….……….
ASSEMBLING:7.1
Assemble clean and dry accessories in following manner.
7.2
Raceway along with pusher slide and magazine
7.3
Front and back cover.
7.4
Empty capsules hopper.
OPERATION:8.1
Ensure that all parts of machine are cleaned as per standard procedure.
8.2
Load empty capsules in hopper.
8.3
Switch on mains of machine.
8.4
Fit capsules loading plate on loading table.
8.5
Push loading plate inside by turning front knob in clockwise direction. Push the green button to load capsules.
DISMANTLING:9.1
Remove the front and back cover.
9.2
Remove the empty capsules hopper.
9.3
Remove magazine followed by pusher plate and raceway. Clean machine and dismantled parts as per standard cleaning procedure.
CAUTIONS: Switch off the electrical mains of the machine.
TITLE: SOP FOR CLEANING & OPERATION OF Page : 01-02 DEHUMIDIFIER Deptt.: PRODUCTION SOP No.: SPD/30 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1) 5.2)
5.3) 5.4)
5.5)
To lay down a Procedure for Cleaning and Operation of Dehumidifier. Q/C Manager.
Switch off the mains Clean all surfaces of instruments by clean dry cloth, then with wet cloth dipped in 0.1% Teepol solution. Clean it again with next dry lint free cloth. Take out the Pre-filter and wash it with 0.01% Teepol solution and finally with DM Water. Dry pre-filter with the dry heat blow.
5.6)
The water storage SS tank is thoroughly washed and cleaned with 0.1% Teepol solution and finally with DM Water.
5.7)
1st ice formation takes place on the inner surface of Pre-filter. Get it cleaned by spraying hot DM Water spray and finally get it dried by blowing warm air current.
TITLE: SOP FOR CLEANING & OPERATION OF Page : 02-02 DEHUMIDIFIER Deptt.: PRODUCTION SOP No.: SPD/30 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.…………... 6.
Sign.…….……….
OPERATION:6.1
Ensure that all parts of machine are cleaned as per standard procedure.
6.2
Check the manufacturing area from the point of exposures and disturbances.
6.3
Switch on mains of electricity supply after all setting of its implements, if area is found perfect.
6.4
Keep it ON before one and half hours of the start of working.
6.5
Check relative humidity percent of the area half on hourly.
6.6
After getting the desired temperature and relative humidity percentage, production conducted scientifically.
6.7
Temperature regulation of the working area is to be controlled by air conditioning procedure.
6.8
Record all valuable data in record format.
CAUTION: In case of any abnormal sound or disturbance from machine during operation, stop it and report to maintenance for overhauling.
TITLE: SOP FOR CLEANING & OPERATION OF STRIP Page : 01-02 PACKING MACHINE Deptt.: PRODUCTION SOP No.: SPD/31 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1
To lay down a Procedure for Cleaning and Operation of Strip Packing Machine. Q/C Manager.
CLEANING:
5.1.1
Switch OFF the mains.
5.1.2
Clean the strip-packing machine with Teepol solution (0.1%) or eq. soap solution by nylon cloth / foam.
5.1.3
Remove the strip forming roller, ink device, hopper, chute, channel, plate, sealing roller etc.
5.1.4
Clean them with Teepol solution (0.1%) or eq. soap solution by nylon brush/ brass brush.
5.1.5 5.1.6 5.1.7 5.1.8 5.1.9
Rinse with raw water, and finally with DM Water. Clean the conveyor belt with the Teepol solution (0.5%) or eq. soap solution by nylon cloth / foam. Rinse with raw water. Then Rinse with DM Water. Proper oiling and greasing in the machine is necessary before installation of machine. After drying, reassemble the machine.
TITLE: SOP FOR CLEANING & OPERATION OF STRIP Page : 02-02 PACKING MACHINE Deptt.: PRODUCTION SOP No.: 31 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.……..……... Sign.…….………. 5.2
OPERATION : 5.2.1 5.2.2
Switch OFF the mains. Before the starting of the machine, check the sealing roller, forming rolls, guide track, chute, hopper etc.
5.2.3
Fill ink with the inkpot, and fix the stereos.
5.2.4
Start the temperature-heating element and forming roller switch.
5.2.5
When temperature reaches at approx 120OC. fix the aluminum foil of the required product.
5.2.6
Now start the machine to check the forming cavity and sealing of strip.
5.2.7
Load the hopper with capsules/ tablets for commercial packing.
5.2.8
Check the sealing of strip by leak test method.
TITLE: SOP FOR CLEANING & OPERATION OF SIFTER
Page : 01-02 Deptt.: PRODUCTION SOP No.: SPD/32 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Cleaning and Operation of Sifter. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. As soon as the shifting process is over, dismantle the following parts:
a)
SS feed hopper
b)
SS frame, holding the sieve in place
c)
SS wire mesh sieve.
5.1 Remove all the residual powder adhering to the above mentioned articles with the help of a nylon brush. 5.2 Wash these articles with hot water. 5.3 Wash these articles with 0.1% Teepol solution. 5.4 Clean these articles with running water to remove all traces of detergent. 5.5 Drain off all the water and dry all the articles. 5.6 Clean the exterior of the sifter stand and motor assembly with the help of a lint free wet cloth. 5.7 Carry out step 1 to 5 for the SS base plate with discharge outlet attached to the sifter stand. 5.8 Assemble all the cleaned / dried articles from step 5 on the Sifter stand frame. TITLE: SOP FOR CLEANING & OPERATION OF SIFTER
Page : 02-02 Deptt.: PRODUCTION SOP No.: SPD/32 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.…………... 6.
7.
Sign.…….……….
Affix a clean label giving following information: a)
Name of the equipment.
b)
Name of the last product shifted.
c)
Name of the operator who cleaned the equipment.
d)
Date of cleaning.
e)
Supervised by
OPERATION: 7.1
Before starting the shifting operation, ensure that the machine is clean.
7.2
Put appropriate quantity of material to be shifted on the SS mesh sieve using cleaned SS scoops.
7.3
Tie polybags kept in SPD/Plastic drums to the outlet of Sifters with the help of twine.
7.4
Switch “ON” the machine.
7.5
After the drum is filled to 80-90% capacity, tie the polybag, close the lid of drum and fix identification label on it showing the Name, Batch No. & Batch Size of the product.
7.6
Repeat steps 2 to 5 until the shifting process is completed.
7.7
After the operation is over, fix ‘To be cleaned’ label on the machine.
7.8
Clean the Sifter as per SOP.
CAUTION: Please clean before use. TITLE: SOP FOR HANDLING OF FINISHED PRODUCTS IN STORE SOP No.: SPD/33 Effective Date: 15-07-2007 Revision No.: Prepared by: Checked By:
Page : 01-03 Deptt.: PRODUCTION Review Date: 14-07-2009 Approved By
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Asstt. Production Chemist
Production Manager
Q.A. Manager
Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
4)
SCOPE :
5)
PROCEDURE
Director Sign.…….……….
To lay down a Procedure for Handling of Finished Products in Store. Q/C Manager. Production Manager/Q.A. Manager
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. :
5.1
Goods laying in the factory goods distribution store.
5.2
If the product has remained in the above stores for a longer period then on the request of store In-Charge, the goods are sampled and subjected to stringent inspection and required analysis by Q.C. Department.
5.3
Random sampling is carried out by the in process supervisor in presence of Q.C. officer in accordance with the statistical Production & for this purpose normal level of sampling to be done.
5.4
Samples collected from the stores and sent to the Q.C. Department for analysis Within 15 days along with format test reports are reported. The operation on the suitability or otherwise of product for distribution is also forwarded along with analysis report by Q.C. Manager to the store In-charge.
5.5
If the product is found satisfactory by Q.C. department it can be released for distribution.
5.6
If the results are unsatisfactory the product returned by the stores in charge to the factory for reprocessing and repacking if required, immediately after the receipt of the Q.C. report.
5.7
If the quality of the product during storage is found to have deteriorated / degraded to an extent that it is unfit for re-processing the same is destroyed with the permission of production director/ production manger in presence of representative of Q.C. department certificate to this effect in triplicate and Signed by the store in charge and Q.C. manager issued, one copy to be retained by the Signing authorities and third copy to be filled in the BPR, of concerned batch of the product.
TITLE: SOP FOR HANDLING OF FINISHED PRODUCTS IN Page : 02-03 STORE Deptt.: PRODUCTION SOP No.: SPD/33 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.…………... 5.8
5.9
Sign.…….……….
The following particulars are entered in the register maintained by stores:5.8.1
Serial No.
5.8.2
Name of the product.
5.8.3
Date of Mfg. and Date of Exp.
5.8.4
Quantity involved.
5.8.5
Randomly sampled Quantity
5.8.6
Stock in hand.
The following particulars are entered in the register maintained by Q.C. Department:5.9.1
Serial No.
5.9.2
Name of the product.
5.9.3
Date of Mfg. & Date of Exp.
5.9.4
Sample received from
5.9.5
Date of receipt
5.9.6
Date of analytical report
5.9.7
QA Manager’s opinion
5.9.8
Quantity destroyed.
5.9.9
Date of destruction of stocks.
5.9.10
Signature of Q.C. Manager.
5.10
Goods lying in branch ware /house company depots if any :-
5.11
Products may be damaged during transport. It can be in the form of breakages without damage to content or physical damage. Base on the type and extent of damage. Branch or depot in-charge is decide the action. The inchange samples the product as per sampling plan and send for Q.C. Department.
TITLE: SOP FOR HANDLING OF FINISHED PRODUCTS IN Page : 03-03 STORE Deptt.: PRODUCTION SOP No.: SPD/33 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
5.12
Goods lying in the transporter’s go-down or received back by the depot from market.
5.13
The product inspected for physical damage, if any on receipt from the transporter’s go-down by the stores in-charge at the branch depot, based on the type and extent of damage. The branch personnel are further action.
5.14
If the product needs any re-dressing or reprocessing the same is subjected to treatment as above.
TITLE: SOP FOR PACKING OPERATION
Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/34 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Packing Operation.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE :
5)
PROCEDURE
Production Manager/Q.A. Manager
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. :
5.1
After issue of packing material from warehouse, check for identity and quantity.
5.2
Store printed material properly
5.3
Before starting of operation the labels and cartons are checked for any defect. Check identity of product & Quantity of product before starting of packing operation.
5.4
Before starting fresh batch all material required are brought and kept at relevant place only.
5.5
Get the line clearance.
5.6
After packing is over, inform Q.A. for their check.
5.7
Deliver the goods to the warehouse only on receipt of final approval from Q.A.
5.8
Disposal of excess labels, cartons and records is done as per SOP No. SPD/12.
5.9
Clean up the area at the end of days work.
TITLE: SOP FOR CLEANING OF PASTE KETTLE
Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/35 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 1)
PURPOSE
:
To lay down a Procedure for Cleaning of Paste Kettle.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
4)
SCOPE :
5)
PROCEDURE
Production Manager/Q.A. Manager
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. :
5.1
The General Utensils like S.S. Container, S.S. Scoops, and S.S. Trays etc. are washed with water.
5.2
Wash with liquid soap or detergent with gentle rubbing. Then wash with fresh water until the detergent foam is completely washed out.
5.3
Finally wash with DM water and get wash utensils checked from the Q.C. lab.
5.4
Mop with dry, clean cloth.
TITLE: SOP FOR GENERAL CLEANING OF EQUIPMENT IN Page : 01-01 MANUFACTURING AREA Deptt.: PRODUCTION SOP No.: SPD/36 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
4)
SCOPE :
5)
PROCEDURE
To lay down a Procedure for General Cleaning of Equipment in Manufacturing Area. Q/C Manager. Production Manager/Q.A. Manager
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. :
5.1
Check electrical terminals for insulation and soundness of terminal connections. Check soundness of electrical switches and its contacts.
5.2
At the end of the shift the equipment is cleaned.
5.3
Clean all the machine parts using potable water. Then wash with 0.1% Teepol solution. Then rinse with potable water and then rinse with D.M. Water.
5.4
Finally rinse with D.M. water and send the wash water to Q.C. Department for analysis.
5.5
Wipe dry the surfaces, using clean dry cloth.
5.6
After getting O.K. report from Q.C. Department, put a tag on machine “CLEAN & READY FOR USE”.
TITLE: SOP FOR ADVERSE HEALTH CONDITION OF Page : 01-01 PERSON IN MANUFACTUEING AREA Deptt.: PRODUCTION SOP No.: SPD/37 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
4)
SCOPE :
5)
PROCEDURE
To lay down a Procedure for Adverse Health Condition of Person in Manufacturing Area. Q/C Manager. Production Manager/Q.A. Manager
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. :
5.1
The people who are sick & ill or suffering from any disease are not permitted in production area.
5.2
The production Deptt. allows sick leave to sick person.
5.3
If any person feels discomfort in the production area or feel ill then inform immediately to concern supervisors / in-charge.
5.4
As a fixed policy of organization, the people are shifted outside the production area under medical aid.
TITLE: SOP FOR INTERNAL LABELING DURING Page : 01-02 QUARANTINE, STORAGE AND PROCESSING Deptt.: PRODUCTION SOP No.: SPD/38 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
Sign.…….……….
To lay down a Procedure for Internal Labeling during Quarantine, Storage and Processing.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
4)
SCOPE :
5)
PROCEDURE
Q/C Manager. Production Manager/Q.A. Manager
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. :
5.1
Paste “Material under Test” printed yellow sticker on all the containers, of that material, which are under test.
5.2
Paste “Approved slip” printed green sticker on the entire container, of those material which are Tested by Q.C. Deptt.
5.3
Paste “Sampled” printed sticker on those containers, whose content are sampled.
5.4
Paste “Rejected” printed red sticker on those containers, which contain rejected material.
5.5
Paste the following sticker on containers which are under operation.
TITLE: SOP FOR INTERNAL LABELING DURING Page : 02-02 QUARANTINE, STORAGE AND PRICESSING Deptt.: PRODUCTION SOP No.: SPD/38 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sticker 1. 2. 3. 4. 5. 6.
3.3 IDENTIFICATION SLIP Name of Product ……………….. Batch No………………. Batch Size………………… Mfg. Date………………….. Exp. Date…………………… Remarks………………… Signature
TITLE: SOP FOR RECEIPT OF PACKING MATERIAL IN Page : 01-01 PRODUCTION Deptt.: PRODUCTION SOP No.: SPD/39 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
4)
SCOPE :
5)
PROCEDURE
To lay down a Procedure for Receipt of Packing Material in Production. Q/C Manager. Production Manager/Q.A. Manager
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. :
5.1
Prepare requisition slip for the packing material.
5.2
Check and certify that the requisition slip is correct in all respect and get it authorized from production manager.
5.3
Deposit in stores for issuing the packing material.
5.4
Receive the issued material through the packing store material gate of production block.
5.5
Physically check and count all packing material received against requisition slip.
5.6
Acknowledge the receipt of material on requisition slip and file the departmental copy of BPR.
5.7
Stock the issue quantities properly in a manner to avoid damage due to over loading or fall down.
5.8
Store the received labels in cupboard and other printed packing components in a locked room. Restrict the access to this area.
5.9
Segregate the similar looking packing components.
5.10
Store the adhesives in tight container.
TITLE: SOP FOR DISPOSAL & SALAVAGE OF REJECTED/ Page : 01-03 EXPIRED/ UNUSABLE MATERIALS Deptt.: PRODUCTION SOP No.: SPD/40 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
4)
SCOPE :
5)
PROCEDURE
5.1)
To lay down a Procedure for Disposal and Salavage of Rejected / Expired / Unusable Material. Q/C Manager. Production Manager/Q.A. Manager
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. : The procedure mentioned has deals with three categories of unusable materials:-
Rejected Material: a)
Which does not confirm the stipulated standard?
b)
Rejection during processing to store.
c)
Final product which fails to meet the standard.
5.2)
Expired Materials: Input materials or finished product which has lost its credential due to non-usage for a period of over the years.
5.3)
Unusable Materials: a)
Information of such items, which have become obsolete due to change of process / packing materials, which have lost its physical / chemical or biochemical properties.
b)
All rejected, expired and unusable materials are pasted with red stickers, so that they can be identified and are physically separated from the other materials.
c)
These materials are kept either in its original packing or in double poly bags duly knitted or sealed and bearing a sticker (red) with following informations.
TITLE: SOP FOR DISPOSAL & SALAVAGE OF REJECTED/ Page : 02-03 EXPIRED/ UNUSABLE MATERIALS Deptt.: PRODUCTION SOP No.: SPD/40 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE RED COLOURED STICKER OF REJECTED MATERIALS SARTHAK BIOTECH Pvt. Ltd., 198/A, Sector-3, HSIIDC, KARNAL-132 001 D.L. No. : 619 B (H) & 977 OSP (H)
REJECTED Pack No.______________ Raw Material___________________________________ Batch No.______________________________________ Date of Mfg.____________________________________ Date of Exp.____________________________________ Qty.___________________________________________ Mfg. By________________________________________ Supplied By_____________________________________ Test Date_______________________________________ Analytical Report No._____________________________ Control Ref. No__________________________________ Failed Parameter_________________________________
Sig. of Q.C. Person These materials are kept in a separate area in stores and periodically disposed off by either returning them to the supplier or sending them to scrap yard. From scrap yard the saleable items are sold through scrap dealers. Other materials are destroyed by burning. Raw materials, Chemicals, powders are drained out after proper treatment. The record of disposal is maintained at production/ stores department, in the form of registers. TITLE: SOP FOR DISPOSAL & SALAVAGE OF REJECTED/ Page : 03-03 EXPIRED/ UNUSABLE MATERIALS Deptt.: PRODUCTION SOP No.: SPD/40 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE All the salvage by burning is authentic carSed by the following person.
1)
In charge of either Production / Stores (concurred deptt.)
2)
In-charge of Production.
The record of such goods disposal are maintained in the following format. S.No.
Material
Reason of non usage Qty.
Date of Disposal /Salvage
Signature of I/C Q.A.D.
Signature of I/C Prod Deptt
Salvage of materials that release foul smell or toxic gases on burning. a)
Such materials are dumped in a closed 3’ x 3’ x 2’ (deep) pit by removing the cover/li
b)
The Pit contains earth, salt & Caustic Soda.
c)
Every fortnight water is poured in the pit, so that over the years, the material become part of the earth itself.
TITLE: SOP FOR THE WASTE COLLECTION FROM Page : 01-01 PRODUCTION AREA Deptt.: PRODUCTION SOP No.: SPD/41 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
Sign.…….……….
To lay down a Procedure for the Waste Collection from Production Area.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1
Clean any spoilage on shop floor immediately.
5.2
Empty the dustbin of packing department at an interval of every one hour.
5.3
Collect waste from all the sections in scrap yard.
5.4
Sort out the waste from packing section in presence of packing supervisor.
5.5
Dispose the waste into the scrap yard.
5.6
Destroy all scrap printed packing material by incineration in presence of quality assurance and security personnel. Record the destruction.
5.7
Lift the scrap from scrap yard every evening.
TITLE: SOP FOR CLEANING OF CONVENTIONAL COATING Page : 01-02 PAN Deptt.: PRODUCTION SOP No.: SPD/42 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
Sign.…….……….
To lay down a Procedure for Cleaning of Conventional Coating Pan. Q/C Manager.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1
As soon as the coating operation is over, remove the coated tablets in suitable containers. Remove the dry powder from the pan, if any.
5.2
Pour approximately 20 liters of hot water (80-85OC) into the pan and allow the pan to rotate for about 10 minutes. Remove this turbid water using a plastic mug and transfer it into a plastic bucket. Clean the inner surface of the pan with angular wooden brush having nylon bristles.
5.3
Place about 500g of sodium bicarbonate into this pan and gradually put about 20 liters of hot water (80-85OC) into the pan taking care that the eyes are well protected by goggles and full size PVC gloves are worm to cover arms. Allow the pan to rotate for 10 minutes. Remove this turbid water.
5.4
Place about 10 liters of warm water (40-45OC) into the pan. Allow the pan to rotate and continue to clean the inner surface of the pan with the angular wooden brush having nylon bristles. Remove the water and check that the inner surface of the pan is free from any powder of foreign particles.
5.5
Place approximately 10 liters of warm water (40-45 OC) into the pan and allow the pan to rotate for about 5 minutes. Remove this water. This rinse water is free from alkali. Repeat rinsing with 10 liters of warm water until the rinse water is free from alkali as indicated by a pH paper.
5.6
Allow the pan to rotate and wipe the inner surface of the pan with a lint free cloth. Look for any scratch pits on the inner surface of the pan.
TITLE: SOP FOR CLEANING OF CONVENTIONAL COATING Page : 02-02 PAN Deptt.: PRODUCTION SOP No.: SPD/42 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 5.7
Sign.…….……….
Cover the mouth of the coating pan with a nylon lid, affix the cleaning ticket indicating the following. - Equipment / Machine - Last Production -
Batch No.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE - Cleaned and ready for product -
Batch No.
- Cleaned by - Date - Signature. 6)
BLOWER ASSEMBLY: A
B.
PROCEURE FOR BATCH TO BATCH CHANGEOVER 1.
Dismantling – Remove the blower pipe from the body.
2.
Cleaning of blower pipe – Clean the blower pipe from inside and outside using compressed air. Wipe the external surface with a duster.
3.
Cleaning of the blower body – Wipe the external surface with a duster.
PROCEDURE FOR PRODUCT TO PRODUCT CHANGEOVER. 1.
Dismantling – Remove the blower pipe from the body.
2.
Cleaning of blower body – Clean the body surface, motor and fan using compressed air from outside as well as inside. Deduct the external surface with a duster. Wipe it with wet duster and dry it with a duster.
3.
Cleaning of blower pipe – First clean it from inside and outside with a jet of potable water using a soft nylon brush. Then clean with 0.1% Teepol solution and again with a jet of potable water. Finally rinse with DM Water.
4.
Drying of the blower pipe – a)
Fix the cleaned pipe on the cleaned blower body
b)
Start the hot air blower.
c)
Adjust the temperature of the air to 100OC.
d)
Continue air flow till pipe gets totally dried.
e)
Switch off the heater of air blower and allow to cool to room temperature.
TITLE: SOP FOR CLEANING OF FLUIDIZED BED DRYER
Page : 01-02 Deptt.: PRODUCTION SOP No.: SPD/43 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Cleaning of Fluidized Bed Dryer. Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4) 5)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. PROCEDURE : Drying is required to remove moisture from wet granulation. Fluidized bed dryer offers saving of time and labour thus increasing efficiency. It is better described as air diffusion drying system. It is essential that the Production Manager confirm that the equipment is in clean condition before the same is used for any of the operations, in order to avoid cross contamination. Following cleaning and assembly procedure are followed whenever there is a product change over or after the completion of 10 batches of the product even if the same product granulation is to be continued thereafter. A.
Procedure for Product Changeover: 1.
Cleaning external surface and plenum: – Clean the body of the drier and plenum with a dry clean duster. Then wipe it with a duster soaked in 0.1% Teepol solution followed by a duster soaked in D.M. Water.
2.
Dismantling: a)
Detach finger bag from hook by opening Perspex windows in the retarding chamber.
b)
Unclamp the fixing bolts of retarding chamber and allow it to rest on the trolley. Take out trolley along with the finger bag and retarding chamber.
c)
Remove the finger bag.
d)
Remove bowl.
TITLE: SOP FOR CLEANING OF FLUIDIZED BED DRYER
Page : 02-02 Deptt.: PRODUCTION SOP No.: SPD/43 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
3.
Cleaning of finger bag- Dedust individual finger chamber of finger bag. Keep it in a polythene bag and send it for laundering to linen Deptt.
4
Cleaning of retarding chamber, trolley and bowl – Take retarding chamber along with trolley and bowl to washing area. Wash retarding chamber,
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE trolley with hot water scrubbing with clean nylon scrubber. Then wash them 0.1% Teepol solution, rinsing thoroughly with hot water followed by D.M. Water. In case of sticky powder use steam. 5
Confirming effectiveness of cleaning – The DM Water rinse of retarding chamber and bowl is sent to Q.C. Department to confirm absence of previous product.
6
Assembling – Fix the laundered finger bag in a metallic hanger around the retiring chamber. Clamp the retarding chamber on the body with the fixed bolts. Lift the bottom of FBD. And seal the trolley with bowl to the retarding chamber.
Note: 1) 2) B.
Fix the ‘Cleaned Slip’ Label. Step No. 5 is a validatory exercise to be conducted at the time of product changeover.
Procedure for batch to batch changeover:
6)
Clean the body of the drier and plenum with a dry clean duster.
6)
Clean the interior surface of the retarding chamber, bowl, trolley.
6)
Wipe the interior of the retarding chamber and bowl with a clean dry duster.
6)
Dedust the fingers of the finger bag.
TITLE: SOP FOR CLEANING AND OPERATION OF Page : 01-04 MULTIMILL Deptt.: PRODUCTION SOP No.: SPD/44 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Cleaning and Operation of Multimill. Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
The entire Machine Operation & Cleaning procedure is divided in three stages.
5.1
Pre-operative Cleaning & Setting.
5.2
Operation
5.3
Post Operative Cleaning and equipment preparation.
STAGE – I a)
The exterior of the machine is cleaned with dry cloth
b)
The electrical connections are restored by pulling the plug top into the socket.
c)
The “MACHINE READY FOR USE” Sticker is removed and sticker/tag showing product, Batch No. etc. is put on the top cover of the machine.
d)
Set the required size of sieve on the machine.
e)
A plastic bag having two sides opening are tied to the delivery chute.
f)
Below the chute, collection bag in fiber down is kept.
g)
The container containing 6.wet) mass is brought near the machine.
TITLE: SOP FOR CLEANING AND OPERATION OF Page : 02-04 MULTIMILL Deptt.: PRODUCTION SOP No.: SPD/44 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
STAGE – II a)
The multi-mill is switched on and run for few seconds to observe whether if is running normally or not.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE b)
Fix knives in rotor as per requirement of sizing i.e. ‘impact edge’ or ‘knife edge’ forward.
c)
Ensure that blades fixed in the rotor are in 4, 3, 4, 3, sequence and none of the blades are missing. Fix the key to the central shaft.
d)
Fix the rotor with blades to the central rod of multimill with rotor fixing screw.
e)
Fit the required intact screen base plate on multimill properly tightening two side’s nuts.
f)
Fix the belt on the appropriate wheel of the pulley, so as to get required speed fast, medium or slow. Give proper tension to the belt by moving movable pulley apart and lock it in position.
g)
Check the knives of the rotor are not touching the screen by turning the belt by hand.
h)
Close and lock the milling chamber guards.
i)
Fix the feeding hopper and cover it with lid.
j)
If any abnormal sound is heard the machine is referred to maintenance dept. for rectification.
k)
In other case the machine is started and the mass is put on the hopper slowly and gradually.
l)
The granulated mass is collected in the poly bag kept in fiber drum.
m)
The process is continued till the entire mass is granulated.
n)
If further granulation of the same batch is required it is continued.
TITLE: SOP FOR CLEANING AND OPERATION OF Page : 03-04 MULTIMILL Deptt.: PRODUCTION SOP No.: SPD/44 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
o)
In case of batch changes the contact parts are cleaned by clean cloths.
p)
In case of Product or composition change the entire m/c is washed and wash water analysis is to be done to by Q.C.D. render the m/c ready for further use.
STAGE – III
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE a)
After the day’s operation or Production change or change of composition all the contact parts like cutter knives, screen, cover and hopper etc. are thoroughly cleaned using liquid soap/detergent and wash the machine till foam of detergent/liquid soap completely washed out. Finally wash with D.M. water and wash water is sent to Q.C.D. for testing.
b)
Place a new polythene bag in a clean plastic container and tie to the bottom of the multi-mill chamber.
c)
Load the material to be milled into feeding hopper by means of a clean SS scoop with handle.
d)
Switch on the main switch and start milling.
NOTE: When the container is full, switch off the mill and the untie the poly bag from the mill chamber. Tie the bag and fix appropriate ‘label’ to the container. Repeat the procedure as often as required, always fixing the container in similar manner to the discharge chamber of the mill e)
At end of the milling operation, switch off the mill and disconnect the electrical mains.
NOTE: The dismantled parts are cleaned on the same day of the operation. If the mill is to be used the same product, do not dismantle but tie a fresh poly bag on bottom of milling chamber, awaiting a new load for milling. If any unusual noise is heard during the milling operation, stop the machine to remove the receiving container. Dismantle the mill and note the cause of noise. Inform the maintenance department of the problem. Quarantine the mill as well as the container pending further packing. f)
Once the wash water analysis is cleared by Q.C.D. The contact parts and other parts are moped and dried.
TITLE: SOP FOR CLEANING AND OPERATION OF Page : 04-04 MULTIMILL Deptt.: PRODUCTION SOP No.: SPD/44 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... Sign.…….………. g) Taking out the plug top then cuts off the connection from the socket. h)
A sticker starting “MACHINE READY FOR USE” is put on the machine to render it ready for use.
A logbook is kept for each machine of aeration in the following format: LOG BOOK OF MACHINE/EQUIPMENT
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Name of Machine/Equipments: MULTIMILL
Page No.:………......……….
Machine/Equipment Code:
SOP No.: SPD/10
Location:……….......……….. Date
Start Time
Finish Time
Total Hours of Running
Break Down START END
Down Time Hours
Production/ Batch No.
Operated By
Checked By
TITLE: SOP FOR CLEANING OF POLISHING PAN
Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/45 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Cleaning of Polishing Pan.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
:
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5) 6)
PRECAUTION
:
Wear rubber gloves, goggles and protective clothing during this procedure. PROCEDURE : TABLET: As soon as the polishing operation for a particular batch of coated tables is over, remove the polished tablets in a suitable poly – lined aluminium containers. Label these containers appropriately and store these containers in the quarantine. Ensure that the other equipment in the polishing room such as tray drier, multimill, trolley etc is suitably covered. Carry out the cleaning operation as follows: 6.1
Remove all the identification of previous batch.
6.2
Vacuum cleans the inside of the pan to remove loose particles.
6.3
Remove excess wax by scrapping with the knife and then clean with a nylon brush.
6.4
Remove the canvas cloth.
6.5
Apply a fresh coat of wax ( White Bees Wax dissolved in Chloroform).
6.6
Cover the equipment with a fresh cloth over till the commencement of the next operation.
6.7
Affix a ‘Label for Cleaning’ indicating the following. -
Equipment/ Machine
-
Last Product
-
Cleaned and ready for Product
-
Cleaned by
-
Date
-
Signature
TITLE: SOP FOR CLEANING AND OPERATION OF CAPSULE Page : 01-02 FILLING MACHINE (SEMI-AUTOMATIC) Deptt.: PRODUCTION SOP No.: SPD/46 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Cleaning and Operation of Capsule Filling Machine (Semi-Automatic). Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. CLEANING :
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.1 Dedust external surfaces using clean nylon brush. Remove the filter bag of the vacuum placed behind the machine.
5.2 Clean the parts by washing with 0.1% Teepol solution and scrubbing with soft clean nylon brush. Rinse with potable water followed by rinsing with DM water.
5.3 Clean the capsule plates by soaking in hot water for 10 minutes. The holes are cleaned using 0.1% Teepol solution. Rinse with potable water followed by rinsing with DM water.
5.4 Clean the machine body with 0.1% Teepol solution & scrubbing with soft nylon brush. Then rinse with potable water.
5.5 The DM water rinse of capsule plates is sent to QC Department to confirm absence of previous product.
5.6 The cleaned parts are dried using clean lint free cloth. The capsule plates are air dried TITLE: SOP FOR CLEANING AND OPERATION OF CAPSULE Page : 02-02 FILLING MACHINE (SEMI-AUTOMATIC) Deptt.: PRODUCTION SOP No.: SPD/46 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 6)
Sign.…….……….
OPERATION: 6.1
After receiving the QC report fix a label. “READY FOR USE”.
6.2
After getting QC report, reassemble the capsule machine for filling of next batch (Product).
6.3
Fix the Guide Plate on the machine.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 6.4
Weigh qty. of powder to be filled for 300 capsules. Put the powder on the capsule magazine; spray the powder by a plastic made spreader.
6.5
Press the top plate on filled magazine.
6.6
Load the caps part of the capsules, and lock the plate by pressing with handle.
6.7
Loosen the lock bolt, remove the filled capsules.
6.8
Continue the same process, till the batch is finished.
6.9
Record the machine cleaning / operation in record. Format.
PRECAUTIONS: Rejected capsules are separately packed in a corrugated carton and labeled as “REJECTED” and transferred to quarantine area.
TITLE: SOP FOR CLEANING OF SPRAY GUN
Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/47 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Cleaning of Spray Gun.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.1
Dismantling: - Remove the gun from stand. Dismantle parts of the gun (aircap/needle/nozzle).
5.2
Cleaning of gun: a.
Dip the gun is SS bowl containing hot potable water, for about ½ hour.
b.
Mop with nylon brush.
c.
Rinse thoroughly with running water.
d.
Scrub the external surface of gun air cap and needle with 0.1% Teepol solution. Rinse with potable water.
e.
Finally clean it with DM Water.
f.
Send the wash water sample for analysis.
g.
After getting analysis report, reassemble the parts.
5.3
Drying of the Gun body: – Wipe the dismantled part and body of the gun with lint free duster.
5.4
Storage: - Store the gun and its part in an appropriate clean poly bag until use.
TITLE: SOP FOR CLEANING OF TABLET DEPARTMENT
Page : 01-02 Deptt.: PRODUCTION SOP No.: SPD/48 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Cleaning of Tablet Department.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
:
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5)
PURPOSE : Cleaning of the floor and wall surfaces in the non-sterile manufacturing area help in removal of the accumulated dust disinfection of the area. This is essential keeping in view the need to preclude any contamination of formulation processed in the manufacturing area. Cleaning and disinfection of the non-sterile manufacturing area is a primary requirement of GMP and is of utmost importance since the particles are continuously generated during the operations contaminating the entire area. The viable /non viable particles settling on the equipment not in use, walls, floors may lead to potential cross contamination if the effective cleaning procedures are not followed.
6)
FREQUENCY: Cleaning and disinfection of the non-sterile area used in order to prevent development of resistant strains of the common contaminating microorganisms.
7)
CLEANING EQUIPMENT: Various equipment such as floor mops, vacuum cleaner and mechanical cleaners are used accordance with the requirements in each area.
8)
AREA COVERED: Granulation, coating, drying compression, strip & blister packing and passages.
TITLE: SOP FOR CLEANING OF TABLET DEPARTMENT
Page : 02-02 Deptt.: PRODUCTION SOP No.: SPD/48 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 9)
Sign.…….……….
CAUTION: No cleaning operation is carried out while processing of a product is on in any of the manufacturing sections like granulation, coating, tablet compression areas etc. In granulation department, individual equipment covered with the cloth cover with the appropriate status label as soon as processing on that particular equipment is over. As soon as the entire processing activity is over, the granulation area cleaned as per the procedure laid down below. All the equipment /machines are covered with fresh cloth covers and labeled appropriately. Same practice is followed for other manufacturing area.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 11)
CLEANING AGENTS AND CONCENTRATION: Phenyl 0.5%, Dettol 5% and Lysol 1.0%.
12)
PROCEDURE: a.
Any spoilage of the materials are cleaned up as soon as it takes place. For this, the vacuum cleaner is used. The tracking of powders from one area to the other caused by the Footwear of the personnel therefore the Personnel is instructed to clean their footwear intermittently.
b.
Cleaning of the floors and the walls is done at the end of the day or shift only after all the equipment/ machine / containers have cleaned and suitably covered.
c.
Initially clean with vacuum cleaner all the floor and wall edges to dislodge any accumulated dust in the crevices.
d.
The entire floor is then cleaned with water and disinfecting agent of the specified concentration and subsequently the floor is dried.
e.
Whenever the product changeover takes place, the Production Manager carefully inspect all the areas and ensure that there is no residue of the previous product and the entire area is ready for use for the subsequent product operation.
f.
Cleaning agent to be changed every fortnight.
TITLE: SOP FOR PASTE PREPARATION VESSEL
Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/49 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Paste Preparation Vessel.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5.1
Check that the knob of gas cylinder is closed.
5.2
Pour the required quantity of material into the vessel as per sequence specified in the product batch manufacturing record.
5.3
Light up the burner of the stove.
5.4
Close the knob of the cylinder after attaining suitable temperature.
5.5
Allow the prepared paste to cool to room temperature
5.6
Unload the cooked paste into suitable container.
5.7
Clean the paste vessel daily as per defined standard operating procedure.
TITLE: SOP FOR DISPOSAL OPERATION IN TABLET Page : 01-01 DEPARTMENT Deptt.: PRODUCTION SOP No.: SPD/50 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Disposal Operation in Tablet Department. Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5.1
POLYTHNE BAGS: All discarded poly bags are collected in container labeled as “Used Poly Bags” slip and send to scrap yard.
5.2
LABELS: Discarded labels are collected in container labeled as “Used Poly Bags” slip and send to scrap yard along with poly bag by house keeping person. Labels of dispensed raw material are teared off and then discarded as above only after the batch is released for packing.
5.3
REJECTED TABLETS: Rejected tablets during the initial run from compression machine are destroyed in a bucket of water. All In-process checked tablets during compression and coating are destroyed in Bucket of water.
5.4
DUST: Dust is collected by vaccum cleaner and machine dust collector. Put it in a poly bag and then discarded by putting it in water.
Discarded punches, damaged finger bags, bowl cover, sieves and screens are handed over to stores on the scrap note after approval by Production & Safety In-charge. The embossed punches are to be defeated under the supervision of Production Manager. These materials are then transferred to scrap yard for destroying.
TITLE: SOP FOR CLEANING & ASSEMBLING OF Page : 01-03 COMPRESSION MACHINE Deptt.: PRODUCTION SOP No.: SPD/51 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Cleaning and Assembling of Compression Machine Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. As soon as the compression of a particular batch is over, clean the entire exterior of the machine as well as the room. Following procedure is adhered to:
1)
Disconnect the electric supply
2)
Dismantle carefully the following parts: -
Feed hopper
-
Acrylic guards
-
Feed-frames.
-
Turret guards
-
Cover plate of the worn shaft.
-
Nylon break plugs along with the spring steel strips
-
Die screws
-
Tablets collecting chutes.
Clean all the above mentioned parts along with relevant bolts thoroughly with hot tap water and keep them aside. a)
Remove carefully all the lower punches by removing the plug and keep these punches in a specially designed wooden tray, serially arranged. Similarly remove all the upper punches and keep them in a separate wooden tray serially arranged. Remove all the dies with the help of SS rod and keep them serially arranged in a one of the above trays.
TITLE: SOP FOR CLEANING & ASSEMBLING OF Page : 02-03 COMPRESSION MACHINE Deptt.: PRODUCTION SOP No.: SPD/51 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... b)
Sign.…….……….
Clean all the interior area of the machine like base plate on which the turret is fitted, cam tracks, die seats , upper and lower punch holes turret surface, first with a dry nylon brush and then with denatured spirit (70% I.P.A.). Care are taken with cleaning the punch hole and die sets so that they are free from any particulate matter.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE c)
Wipe clean the exterior of the machine with a lint free duster.
d)
Cleaning and fitting of dies and punches Take out 2 liters of hot tap water, 10% Teepol (non toxic detergent solution) mixture and clean all the punches by dipping each in hot water, then in Teepol mixture and then cleaning thoroughly with hot DM water. After cleaning all the punches and dies should be put serially in the clean wooden trays meant for storing them.
e)
Use 15 liters of distilled water to give couple of washing to the cleaned parts and the dismantled punches and dies. Inspect the final rinse water for absence of any suspended matter. If required use additional distilled water to get the “clear” rinse water.
f)
Wipe all the cleaned parts from step ‘e’ with a clean dry lint free cloth.
5.1
FITTING OF DIES: - Before the dies are fitted, ensure all the die seats are free from any foreign matter place the die face downwards on the die hole. Apply light pressure with fingers on the top phase of the die to locate centrally over the die hole. After locating the die correctly, drive the die position with the help of SS rod introduced through the upper punch guide holes. Once the die is fitted the top portion of the die flushed with the turret surface.
TITLE: SOP FOR CLEANING & ASSEMBLING OF Page : 03-03 COMPRESSION MACHINE Deptt.: PRODUCTION SOP No.: SPD/51 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 5.2
Sign.…….……….
FITTING OF LOWER PUNCHES: -Take a lower punch and wipe its dry smear with liquid paraffin and introduce it through the lower punch die hole taking care that each numbered punch goes into its corresponding compression station. All the lower punches thus introduced are move freely up and down. Put the plug back into its position. Fix all the cleaned and dried nylon plugs with spring steel strips.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.3
FITTING OF UPPER PUNCHES: -The cleaned and dried upper punches are smeared with liquid paraffin and introduced them in to their respective holes: A)
Put back all the turret guards after wiping them dry. Fit the cleaned and dried feed frame at their respective positions. Install the cleaned and dried acrylic guards and hoppers in their relevant position.
B)
Cover the cleaned machine with a clean cover. Affix a cleaning ticket indicating the following:-
-
Equipment / machine
-
Last Product-
Batch No.
-
Cleaned and ready for production-
Batch No.
-
Cleaned by
-
Date
Supervisor Signature TITLE: SOP FOR TABLETS COMPRESSION TOOLING
Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/52 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Tablets Compression Tooling.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
The quality of the tablet significantly dependent on the condition and quality of the tooling used for compression. The tablet compression tooling consist of a set having I upper punch, I lower punch and die. The concerned Production Manager maintain the following data of the compression machine (for which the tooling is to be used. Name of the Compression Machine (for which tooling set is to be used) Name of the product (for which tooling set is to be used) Number of Upper Punches Number of Lower Punches Name of the manufacturer (of the tooling set) Date of the manufacturer ( of the tooling set) Details of tools received (No. of upper punches, lower punches & dies) Date on which the tooling set was put to use 5.1 TOOLING USE LOG:Date
Product
Est. No. of tablets compressed (in lacs)
Initials of Supervisor
TITLE: SOP FOR STORAGE OF IN-PROCESS TABLETS & Page : 01-01 GRANULES Deptt.: PRODUCTION SOP No.: SPD/53 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Storage of In-process Tablets and Granules. Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
A)
GRANULES: -At the end of granulation process, the lubricated granules are unloaded in suitable no. of Pre-shifting weighed aluminum / plastic containers with polythene bags, up to approx. 80-90% holding capacity of the bags to facilitate proper tying with twine. A label indicating product, batch no., S.No. of container & total no. of the containers for the batch are affixed on the inner side of the lid and one on the exterior of the container. All the containers are weighed again to determine the net wt. of granules. These containers then transfer to quarantine area and stored on SS pallets in 2 roll with maximum height of 2 containers having label on the front side. The containers of different batches are segregated.
B)
TABLETS: - Compressed tablets from the machine are stored in suitable no. of labeled, pre weighed aluminium / plastic containers with polythene bags, up to approx. 80-90% holding capacity of the bags to facilitate proper tying with twine. The label which are affixed on the inner side of the lid and on the exterior of the container with the detail about product, Batch No., S.No. of container & total No. of the containers for the batch. At the end of the compression process all containers are weighed again to determine gross wt. and consequently the net wt. of tablets. The containers are transferred to quarantine area and stores in stacks of four containers not more than three rows per batch having label on the front side of the containers.
TITLE: SOP FOR OPERATION OF FLUIDIZED BED DRYER
Page : 01-02 Deptt.: PRODUCTION SOP No.: SPD/54 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Operation of Fluidized Bed Dryer. Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
CAUTION: i)
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
Check and certify that area and equipment are clean and suitable for starting the operation.
ii)
A.
Ensure that main switch is in ‘OFF’ position before dismantling FBD for loading.
ASSEMBLING: 1.
Unclamp the fixing bolts of retarding chamber and allow it to rest on the trolley. Take out trolley along with the retarding chamber.
2.
Check and certify the suitability of the clean finger bag.
3.
Fix the finger bag in a hanger. Fix the loops of the finger to the hooks of the shaker.
4.
Place the bag in between retarding chamber and fluidization chamber.
5.
Clamp the retarding chamber on the body with fixing bolts.
TITLE: SOP FOR OPERATION OF FLUIDIZED BED DRYER
Page : 02-02 Deptt.: PRODUCTION SOP No.: SPD/54 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... B.
Sign.…….……….
OPERATION: 1.
Load the bowl with material to be dried.
2.
Take the product uniformity in the bowl to avoid lumps.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 3.
Move the product bowl in the retarding chamber keeping the window in viewing position.
4.
Position the bowl.
5.
Lift the bottom of the FBD moving the jack handle to the opposite side and seal the trolley to the retarding chamber.
6.
Check and ensure that there is no leakage.
7.
Set the timer and switch on heating and fluidization, maintaining the desired inlet air temperature.
8.
Stop drying at intervals and dedust the finger bag by shaking it.
9.
Take out trolley and shake the granules to avoid formulation of lumps
10. Watch the fluidized flow through the Perspex window. 11. Continue heating until required outlet air temperature is achieved. 12. Put off the heaters and bring the timer to zero.
C.
UNLOADING: 1
After drying is complete put off main switch.
2
Shake the finger bag vigorously and dedust retarding chamber.
3
Unlock and withdraw the bowl.
TITLE: SOP FOR CLEANING AND OPERATION OF MASS Page : 01-03 MIXER Deptt.: PRODUCTION SOP No.: SPD/55 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Cleaning and Operation of Mass Mixer. Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE : The entire Machine Operation is divided in three stages. I) Pre-operative Cleaning & Setting. II) Operation III) Post Operative Cleaning and equipment preparation. Stage – I a) The shaft, Blade, Cover and inner & outer surface of the machine is cleaned with dry cloth. b) The electrical connections are restored by pulling the plug top into the socket. c) Clean the lid and vessel of the mixer with tap water. d) The mixer is rinsed with hot tap water, to remove adhered lumps of powder, keeping it in tilting position. e) Pour approximately 100-liter water into the mixer. To it add 100 ml of Teepol solution and run the mixer for 15 minutes. Then use nylon brush to remove any adhered material. f) Ensure that no material is adhered to the corner and edges of the shaft. g) Remove the water and rinse with fresh DM Water and dry it by using clean muslin cloth. h) Collect the rinse of the final checking and send to QC Department for checking of contamination from previous product. i) Paste the specified ‘CLEAN SLIP’ label after getting approval from QC Department. j) Cover the mixer lid, when in use.
TITLE: SOP FOR CLEANING AND OPERATION OF MASS Page : 02-03 MIXER Deptt.: PRODUCTION SOP No.: SPD/55 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... k) Protect the mixer from atmosphere dust by using polythene bag. l) Clean the mixer prior to use to manufacturing operation.
Sign.…….……….
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE m) The “MACHINE READY FOR USE” Sticker is removed & sticker/tag 6.identity slip) showing name of product, Batch No. etc. is put on the top cover of the machine. PRECAUTION: A)
Ensure that micro switch is in proper working condition.
B)
Never run the mixer with the lid open continuously.
Stage – II a) The Mass Mixer is switched on and run for few seconds to observe whether it is running normally or not. b) If any abnormal sound is heard the machine is referred to maintenance deptt. for rectification. c) In other case the Bulk (Sieved powder) put into the mass mixer, covers the machine and starts the machine. d) After mixing the content for required time (e.g. for 30 minutes). machine then add the binder (paste).
Stop the
e) Run the mixer for further 15 minutes and get the required wet mass. This wet mass is now ready for milling. Collect out the mass in S.S. Container. f) If further granulation of the same product is required it is continued. g) In case of product or composition change the entire machine is washed and wash water analysis is to be done to by Q.C.D. render the machine ready for further used. TITLE: SOP FOR CLEANING AND OPERATION OF MASS Page : 03-03 MIXER Deptt.: PRODUCTION SOP No.: SPD/55 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
Stage – III a) After the day’s operation or Production change or change of composition all the parts like mass mixer cover, shaft blade & joints, surface (inner & outer) etc.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE are thoroughly cleaned and washed. Final washing to be done by D.M. water and wash water sent to Q.C.D. for testing. b) Once the wash water analysis is cleared by Q.C.D. The Mass Mixer surface (inner & outer), cover, blade shaft etc. are moped and dried. c) The connection is then cut off by taking out the plug from the socket. d) A sticker starting “Machine ready for use” is put on the machine to render it ready for use. A logbook is kept for each machine of aeration in the following format:
LOG BOOK (Mass Mixer) Machine No. ________ Date
Start Time
Page No. ______
Finish Time
Total hrs. of running
Breakdown Start
End
Down Time hrs.
Product & Batch No.
TITLE: SOP FOR TABLETS INSPECTION
Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/56 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Tablets Inspection.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5.1 Before starting the new product / batch, tablets from the previous product/ batch are removed from the inspection area.
5.2 All the containers etc. are removed from the inspection area.
5.3 A label having details about product Batch no. of the new product to be inspected is affixed on the table at which the inspection is done.
5.4 Checker for the inspection of the tablets are changed after every four hours.
5.5 Clean cotton gloves are used for inspection of tablets, gloves are changed after every four hours.
5.6 Proper record are maintained of rejected tablets and type of rejection found as per SOP.
TITLE: SOP FOR HOUSE KEEPING IN TABLETS Page : 01-01 COMPRESSIONS SECTION Deptt.: PRODUCTION SOP No.: SPD/57 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for House Keeping in Tablets Compression Section. Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
TABLET COMPRESSION AREA: 1)
Ensure that all the compressed tablets of the previous product / batch have been removed.
2)
With the help of a vacuum cleaner remove all the dust accumulated on the floor, walls and the exterior surface of the machine
3)
Clean all the SS plates as well as the floor with the help of a wet mop.
4)
All the accessories of the DT apparatus and weighing balance are properly cleaned before commencing compression of the next product / batch.
5)
Inspect the empty aluminium / plastic containers and the polythene bags designated for the product to be compressed, for proper cleanliness and for the label having details about Product Batch No. and Serial No. of containers etc.
6)
Ensure that the compression operator wears proper hand gloves, cap and mask.
TITLE: SOP FOR HOUSE KEEPING IN TABLETS PACKING Page : 01-01 AREA Deptt.: PRODUCTION SOP No.: SPD/58 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for House Keeping in Tablets Packing Area. Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
5.1
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
TABLET PACKING AREA:5.1.1
Ensure proper line clearance before starting packing operation for the next product / batch.
5.1.2
All packing material including over printed material received in full quantity as per indent before starting of any packing operation for the next product / batch.
5.1.3
All the packing material and the bulk tablets are stored in such a way that the product identification is easy and movements of these materials do not lead to accident and hindrance to the movement of personnel.
5.1.4
With help of vacuum cleaner, all the dust on the floor as well as walls and exterior of strip/ blister-packing machine is be removed periodically.
5.1.5
All employees working in the packing area wore clean uniforms. Operator responsible for running the strip-packing machine wore hand gloves and face mask.
5.1.6
At suitable intervals the floors is cleaned by the janitors to clear any spoilage of bulk tablets/ packing materials. Trashes from dustbins are removed regularly. Spoilage of any liquid on the floor should be immediately cleaned and floor should be wiped dry.
TITLE: SOP FOR CLEANING OF MANUFACTURING VESSEL Page : 01-02 (TOPICAL SECTION) Deptt.: PRODUCTION SOP No.: SPD/59 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Cleaning of Manufacturing Vessel (Topical Section). Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5.1 As soon as the manufacturing of the previous product over, disassemble the following parts:a) b) c) d) e) f)
All the Teflon scrappers attached to the anchor. All the stainless steel pipe, valves & tridover joints. Flanges, glass and gaskets. Circular silicon rubber gasket connecting the bowl with top roof. All the homogenizer, parts such as stator, rotor & the housing. All the parts of the pump.
5.2 Connect the bottom discharge valve to the draining with the help of PVC pipe used for draining out the washing.
5.3 Bring the top hood downwards.
5.4 Now pass steam for 5 minutes through the steam inlet to melt wax contents.
5.5 Drain out melted waxy contents through the bottom discharge valve.
TITLE: SOP FOR CLEANING OF MANUFACTURING VESSEL Page : 02-02 (TOPICAL SECTION) Deptt.: PRODUCTION SOP No.: SPD/59 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 5.6 Wipe the entire exterior with cotton cloth.
5.7 Raise the hood and clean interior of the hood and the bowl.
Sign.…….……….
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.8 Introduce 50 Ltrs. D.M. water and bring the hood to the correct position to introduce steam and boil. 5.9 Run 15 minutes to facilitate proper cleaning of the interior Kettle.
5.10
Rinse the interior of compounding vessel with hot tap water and then subsequently with D. M. water to remove all the traces of detergent. It is confirmed by checking the pH of the water.
5.11
Dry the interior and exterior of the compounding vessel with lint free fresh cotton cloth.
5.12
Sanitize the entire interior surface as well as the contra rotary heater with the help of 70% I.P.A. and leave it for drying.
5.13
Reassemble the sets and bring down the hood to its lowest position. After cleaning, the label should stick & mention “READY FOR USE”.
TITLE: SOP FOR CLEANING OF BULK TANK (TOPICAL
Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/60 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director SECTION)
Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Cleaning of Bulk Tank (Topical Section). Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
S.S. Tank used to store bulk until Production Report. In order to exclude the possibility of cross contamination, it is cleaned as per the following procedure.
5.1
Wipe the wax contents from the tank with a lint free clean cotton cloth.
5.2
Clean entire exterior and interior with the help of hot Teepol solution (0.1%).
5.3
Rinse with D.M. Water at least thrice to remove the traces of detergent by checking pH, if detergent is present then rinse with D.M. water again.
5.4
Dry the interior and exterior surface with lint free cloth and after drying sanitize with 70% IPA and affix an appropriate cleaning label.
TITLE: SOP FOR CLEANING AND ASSEMBLING PROCEDURE Page : 01-01 OF TUBE FILLING MACHINE (TOPICAL SECTION) Deptt.: PRODUCTION SOP No.: SPD/61 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Cleaning and Assembling Procedure of Tube Filling Machine (Topical Section). Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
It works on the principle of suctions:-
5.1)
Isolate the machine from power and remover hopper along with valve housing.
5.2)
Remove the nozzle and release pin.
5.3)
Remove the caps holding tube.
5.4)
Check the jaws of the first fold, second fold and embossing and clean with hot Teepol solution (0.1%) and then with plain hot water.
5.5)
The hopper valve housing nozzle release pin, and cap holders are first washed with hot Teepol solution (0.1%). Then use plain hot water at least twice to remove the detergent and dried with lint free cloth.
5.6)
Overall, clean the outside of the machine with hot Teepol solution (0.1%) and rinse twice with plain hot water and dry with lint free wet cloth. If there is any sign of the presence of cream / ointment, repeat the cleaning process. Now sanitize all the parts coming in contact with product with 70% I.P.A.
5.7)
Now reassemble valve housing nozzle and hopper, place the caps back in the belt and the fix the outlet can suitably.
TITLE: SOP FOR POLISHING OF CAPSULES
Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/62 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Polishing of Capsules.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
POLISHING PROCEDURE OF FILLED CAPSULES:-
A separate cubicle is allocated in capsule section for this job. 1)
Remove filled capsule from hopper / container.
2)
Remove powder from powder collection trays.
3)
Dedust external surface with vacuum cleaner and then clean properly with lint free cloth duster. Use clean towel and cotton gloves.
4)
Sometimes, liquid paraffin is used for the polishing.
5)
After polishing keep polished capsule in cleaned, moisture and light free air tight containers.
6)
Separate polishing cloth from polishing chamber and replace it with a fresh polishing cloth. Record is maintained in the format.
TITLE: SOP FOR CLEANING OF S.S. WAX MELTING VESSEL Page : 01-01 (TOPICAL SECTION) Deptt.: PRODUCTION SOP No.: SPD/63 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Cleaning of S.S. Wax Melting Vessel (Topical Section). Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
To prevent from yield variation and assay the melting tank is cleaned as per below direction:-
5.1 When the oil phase is transferred compounding vessel, fill the tank with hot tap water (60OC) and clean inner surface with the help of nylon cloth brush. Again fill the tank up to 90% water of its capacity and steam is passed until the temperature set to 90OC. So that wax melts and get mixed with hot water and drains it. Again fill the tank with (0.1% Teepol solution) and heated to 90 OC. Leave for 20 minutes and drawn off from the mixture and run the tank with plain hot water at least thrice to remove detergent.
5.2 Take 0.01% NaOH and rub the inner surface of the tank to remove any trace of wax.
5.3 Rinse tank with plain hot water and repeat the process three times, to remove trace of alkali and checked by using pH paper.
5.4 Clean the interior of the tank with freshly D.M. water collected.
5.5 Finally clean the lid and place it over the tank and label ‘READY FOR USE’ it. TITLE: SOP FOR FOR POLISHING OF PUNCHES AND DIES
Page : 01-02 Deptt.: PRODUCTION SOP No.: SPD/64 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Polishing of Puches and Dies.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
A.
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
Punches are polished when:1. There is burr or claw on punch tip. 2. Punch tip turns black. 3. Roughness on the tip is observed. 4. Sticking continues on embossing. 5. Appearance of tablet becomes dull.
B.
Dies are polished when:1.
There is ring formation inside die-bore.
2.
Die bore turns black
3.
Corrosion is observed inside die-bore.
4.
Wear or binding takes place in die-bore.
TITLE: SOP FOR POLISHING OF PUNCHES AND DIES
Page : 02-02 Deptt.: PRODUCTION SOP No.: SPD/64 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... C.
Equipment to be used for polishing:1. Motorized polishing machine. 2. RMP of the machine can be controlled.
Sign.…….……….
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 3. Used for cleaning and polishing of punch-Tip and die-bore. D.
Recommended Tools and Compounds:1. Magnifying glass, for identifying the damaged surface and finished of the tip. 2. Nylon brush, (cup type) with emery paste, for cleaning and polishing of punch tip. 3. Oil-stone and lapping stick, for removing the burr or claw. 4. Felt-bob, with emery paste, for polishing the die-bore. 5. Emery paper 150 grit, for removing corrosion from the tools. 6. Diamond past (3 micron) for removing continuous sticking. 7. Silicon paste or luster bar or emery flour, for improving the surface finish. 8. Nylon brush, (wheel type) for polishing embossed tips.
E.
Before starting polishing operation, inspect the tools carefully using magnifying glass and carry out finger nail test, for signs of damage of tip.
TITLE: SOP FOR CLEANING OF UTENSILS, SCRAPPER, Page : 01-01 SPOONS AND SCOOPS (TOPICAL SECTION) Deptt.: PRODUCTION SOP No.: SPD/65 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Cleaning of Utensils, Scrapper, Spoons and Scoops (Topical Section). Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
These are used to transfer bulk form one place to another so there are potentials of cross contamination so it should clean as per the prescribed procedure.
5.1
After using scrapper and utensils, clean all utensils and remove the wax material.
5.2
Clean with (70OC) hot DM water.
5.3
Clean with hot Teepol solution (0.1%).
5.4
Clean all the area like grooves and sharp angle with tiny Nylon brush to remove the left over.
5.5
Clean with hot DM water thrice to remove traces of detergent.
5.6
Wash with hot fresh D.M. water (70OC).
5.7
Sanitize with 70% I.P.A.
5.8
Affix ‘READY FOR USE’ label.
TITLE: SOP FOR REMOVAL OF BULK FROM TUBE FILLING Page : 01-01 MACHINE (TOPICAL SECTION) Deptt.: PRODUCTION SOP No.: SPD/66 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Removal of Bulk from Tube Filling Machine (Topical Section). Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
During filling material is leaked from the side nozzle adjacent to the valve. Discarding of leaked material:-
5.1 Finished material leaked from side and back side of the valve connected in a S.S. container and labeled as “Container For Rejection”.
5.2 This amount is converted into equivalent number of filled tubes utilized for reconciliation.
5.3 Such leaked semisolid is disposed off after filling operation for each batch.
TITLE: SOP FOR IN-PROCESS CONTOL IN MANUFACTURING Page : 01-01 (TOPICAL SECTION) Deptt.: PRODUCTION SOP No.: SPD/67 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for In-process Control in Manufacturing (Topical Section) Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5.1
pH Checking.
5.2
Hopper is filled only half of the capacity.
5.3
While the tube filling operation is on, weight of net filled quantity per tube is checked at the interval of 30 minutes by the I.P., Q/C. by checking the weight of empty tubes and gross weight.
5.4
I.P., Q/C. should check the crimping, coding of the filled Aluminum collapsible tube or plastic tube take and the embossing of Batch number and manufacturing date at the interval of 30 minutes. Quality for embossing is controlled by adjusting pressure excreted by jaws, to prevent pinhole developments on the embossed letter.
5.5
At every interval of 30 minutes following measurements are recorded. i.
Tare weight of tube.
ii.
Minimum weight and maximum weight.
TITLE: SOP FOR HOUSE KEEPING IN TOPICAL SECTION
Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/68 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for House Keeping in Topical Section. Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
i.
Ensure proper line clearance before starting.
ii.
All packing materials are received as per packing.
iii.
Equipment and accessories not in use are properly covered and labeled.
iv.
All employees wore neat & clean uniform, footwear & Surgeon’s cap and mouth cover.
v.
At suitable interval the floor is cleaned, to clear any spoilage from floor.
vi.
The accessories i.e. scoops, spatulas, though in continuous use are nevertheless be adequately covered with polythene sheets and kept at a pre-designated place.
vii.
The operator wore rubber / plastic/ disposable hand gloves, facemask, and as per required.
TITLE: SOP FOR INSTALLATION OF NEW PUNCH SET
Page : 01-02 Deptt.: PRODUCTION SOP No.: SPD/69 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Installation of New Punch Set.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5.1 Before setting of compression machine, immerse all new punches and dies (including extra sets) into sufficient quantity of diesel for 30 minutes.
5.2 Wipe all punches and dies with cotton rags to remove any traces of grease.
5.3 Discard diesel after use, clean the tray of diesel to ensure the absence of any particulate matter from diesel and punch sets.
5.4 Immerse all punches and dies into fresh diesel (sufficient) for 10 minutes and then wipe with cotton rags.
5.5 Check any 2 dies by dipping in fresh clear diesel to confirm the absence any particulate matter.
5.6 Issue the required no. of punches and dies for setting on compression machine and keep remaining extra sets in respective box after oiling. TITLE: SOP FOR INSTALLATION OF NEW PUNCH SET
Page : 02-02 Deptt.: PRODUCTION SOP No.: SPD/69 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
FOR USED PUNCHES AND DIES:a)
Before fixing on machine : 1)
Wipe required no. of punches and dies with duster dipped in clear diesel.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE
b)
2)
Clean the die bore with cotton rags.
3)
After visual inspection of punch tip and die bore, start setting as per SOP.
After removing from machine: 1)
Immerse all punches and dies into sufficient diesel for minimum 30 minute.
2)
Wipe all punches, dies & dies bore with cotton rags and make respective entries in punch stock record.
3)
Apply a thin layer of oil (SAE 40) on punch tip, body head & die bore, after inspecting them in absence of previous material and any damage to punch set.
4)
Keep punches and dies in respective punch boxes in spare part room.
TITLE: SOP FOR IN-PROCESS PACKING (TOPICAL SECTION) Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/70 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for In-process Packing (Topical Section). Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
It gives the product identity, strength and quantity along with information regarding batch no., date of manufacture, date of expiry and price etc. During packing operation, following in process check is carried out at every 30 minutes.
5.1
Correctness of Batch No.
5.2
Correctness of carton, and shipper.
5.3
Correctness of all embossed text.
5.4
Present of filled tubes in the carton .
5.5
Correct no. of outer box per shipper.
5.6
Use of correct colour of the ink.
5.7
Correct weight of filled tube.
TITLE: SOP FOR LINE CLEARANCE (TOPICAL SECTION)
Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/71 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Line Clearance (Topical Section). Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5.1 The packing line should be free from filled product and packing material of previous batch i.e. overprinted carton, rejected tubes, shipper. 5.2 On line rejection are removed. 5.3 Any spoilage is moped & cleaned. 5.4 Packing equipment is properly cleaned. 5.5 If packing machine is not used for one week, it should be re-inspected and if required re-cleaned. 5.6 If above condition is OK, It means line is clear and signed by concerned Q.A. Manager. 5.7 Packing should not commence, until line clearance is endorsed by Q.A. Manager. 5.8 Line clearance is recorded on a suitable FORMAT.
TITLE: SOP FOR CLEANING OF S.S. WATER VESSEL
Page : 01-01 (TOPICAL SECTION) Deptt.: PRODUCTION SOP No.: SPD/72 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Cleaning of S.S. Water Vessel (Topical Section). Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
To prevent from yield variation and assay the water tank is cleaned as per below direction:-
5.1 When the water phase is transferred to compounding vessel, fill the tank with hot tap water (60OC) and clean inner surface with the help of nylon cloth brush. Again fill the tank up to 90% water of its capacity and steam is passed till the temperature set to 90OC drain it. Again fill the tank with (0.1% Teepol solution) and heated to 90OC. Leave for 20 minutes and drawn off from the mixture & run the tank with plain hot water at least thrice to remove detergent.
5.2 Take 0.01% NaOH & rub the inner surface of the tank to remove any trace of wax.
5.3 Rinse tank with plain hot water and repeat the process three times, to remove trace of alkali and checked by using pH paper.
5.4 Clean the interior of the tank with freshly D.M. water collected.
5.5 Finally clean the lid and place it over the tank and label it. TITLE: SOP FOR IN – PROCESS FILL WEIGHT Page : 01-01 DETERMINATION Deptt.: PRODUCTION SOP No.: SPD/73 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for In-process Fill Weight Dentermination. Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
A)
B)
C)
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
During filling operation: 1.
Fill weight is checked at the start of filling and at the interval of 30 minutes from each filling head.
2.
Minimum and Maximum limits for fill weight is established & recorded on the in process sheet.
3.
In case of unacceptable fill weight, re-inspected the filled tube.
After filling operations: 1.
The filled tube must be cleaned.
2.
Finished package contain filled tube.
During filling: 1.
Pre weight and marked two individual tubes.
2.
Fill and record the individual gross, tare & net weights.
3.
Compare net filled weight, obtained net weight to determine average fill weight.
The average net weight is not less than the labeled amount and the net weight of any single container is between 91% to 109% for 5gm to 50gm tubes and between 95.5% to 104.5% for 50 gm to 100gm. TITLE: SOP FOR LABELING & PACKING OF ORAL LIQUID Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/74 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Labeling and Packing of Oral Liquid. Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5.1
Before issuance, check the packing materials.
5.2
Check the overprinting details i.e. Batch No, Mfg. Date, Exp. Date and M.R.P. etc. and tick mark after checking of correctness of overprinting matter enter these data in logbook & get it verified.
5.3
Paste samples of overprinted label and carton, sign. on them and get certified from QA.
5.4
Packing quantity and filled quantity to be checked every 1-hour interval.
5.5
Filled quantity for CB box to be checked every 1-hour interval.
TITLE: SOP FOR CLEANING OF GENERAL UTENSILS, SS Page : 01-01 CONTAINERS. Deptt.: PRODUCTION SOP No.: SPD/75 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Cleaning of General Utensils, S.S. Containers. Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5.1.
The General Utensils like S.S. Container, S.S. Scoops; S.S. Trays etc. are washed with water.
5.2.
Wash with liquid soap or detergent with gentle rubbing then again wash with fresh water until the detergent foam is completely washed out.
5.3.
Finally washed with DM Water and are checked from the Q.C. Lab.
5.4.
Moped with dry clean cloth.
TITLE: SOP FOR CLEANING OF MANUFACTURING AREA Page : 01-04 (TABLET, CAPSULE & LIQUID ORALS) Deptt.: PRODUCTION SOP No.: SPD/76 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Sign.…….……….
To lay down a Procedure for Cleaning of Manufacturing Area (Tablet, Capsule and Orals Liquid). Q/C Manager. Production Manager/Q.A. Manager
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
SCOPE
:
5)
PROCEDURE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5.1 Doors, windows and portion are de-dusted once in the evening after the days work is over. The dust is collected in a closed dustbin. 5.2 Floors of mining blending, tableting, coating & capsule filling etc. areas are de-dusted in the evening after the days work and the dusts are collected in the dust bin. 5.3 Similarly all the hoopers & extensors machines, tables and other furniture and fixtures are de-dusted and the resulting dust is collected in the same dustbin. 5.4 The entire collected dust is dumped in the pit meant for disposal of sensitizing material 5.5 The entire area including windows, doors, table hoops etc. are then moped by using Non Ionic soap:a)
Preparation of soap solution.
b)
Formula:
c)
Process water
-
d)
Non Ionic soap -
20 gm
10 Liters
5.6 The floor of working area is de-dusted with broom slice and moped with detergent solution just before the start of day’s work. 5.7 The machine interiors are not required to be wet moped.
TITLE: SOP FOR CLEANING OF MANUFACTURING AREA Page : 02-04 (TABLET, CAPSULE & LIQUID ORALS) Deptt.: PRODUCTION SOP No.: SPD/76 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
5.8
The moping dish should be strained in the bucket and then dried.
5.9
The remnant of the moping solution is put in the mainhole where the wash water effluent from hormone/ ß-Lactum section is coming.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.10
The walls of the rooms are painted once a year using alkaline/neutral epoxy bound distemper.
5.11
In liquid oral section window pans, doors are moped daily.
5.12
Floors are moped daily in evening after completion of work.
5.13
All m/c & parts are cleaned after completion of work.
TITLE: SOP FOR CLEANING OF MANUFACTURING AREA Page : 03-04 (TABLET, CAPSULE & LIQUID ORALS) Deptt.: PRODUCTION SOP No.: SPD/76 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 6.0
Sign.…….……….
The record is maintained as per following format:
CLEANING RECORD FOR TABLET, CAPSULE & DRY SYRUP MANUFACTURING SECTION
S. No.
Area
Floors
Platform
Walls
Doors/ Windows
Ceilings
Exhaust fan
Ceiling Fan
Tube lights
Done by
Chec ked by
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Date
Washing using scrubber and hose of water, damp mop with disinfectant Twice a day
Cleaning of Cleaning with surface with scrubber and scrubber & hose of water water, mop with disinfectant Twice a week
Vacuum cleaning
Cleaning with 0.1% solution of detergent with moping
Daily
Monthly
Vaccum of Vaccum of Cleaning moping Cleaning moping with 0.1% detergent with 0.1% solution detergent solution
Vaccum of Cleaning moping with 0.1% detergent solution Weekly
Once a day
Weekly
Weekly
TITLE: SOP FOR CLEANING OF MANUFACTURING AREA Page : 04-04 (TABLET, CAPSULE & LIQUID ORALS) Deptt.: PRODUCTION SOP No.: SPD/76 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…...………... Sign.…….………. 7.0
Cleaning Schedule: S. No.
Area Name
Cleaning Schedule
1.
Floors
Twice a day
2.
Platform & Tables
Once a day or after completion of work.
3.
Walls
Twice a week
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4.
Doors / Windows
Daily
5.
Ceilings
Monthly
6.
Exhaust Fan
Weekly
7.
Ceiling Fan
Weekly
8.
Tube Lights
Weekly
TITLE: SOP FOR CLEANING OF S.S. CONTAINERS, PRESSURE Page : 01-01 VESSELS, S.S. TANKS & STIRRER Deptt.: PRODUCTION SOP No.: SPD/77 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
:
To lay down a Procedure for Cleaning of S.S. Containers, Pressure Vessels, S.S. Tanks and Stirrer. Q/C Manager.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5)
PROCEDURE
:
5.1
Transfer the tank, containers with its lid, membrane filter holder and pressure vessels to the washing area.
5.2
Keep aside the lid and other part of vessels at sufficient height.
5.3
Flush the tank and vessel with D.M. Water. Scrub with 0.1% Teepol solution using nylon ball. Wash the lid similarly.
5.4
Wash with D.M. Water to remove all traces of the detergent.
5.5
Rinse with filtered Distilled water, and drain off completely. Fix the lid properly.
5.6
Washing to be monitor by Q.C. Manager regularly.
5.7
Affix a status label and date.
TITLE: SOP FOR CLEANING OF CONVEYOR BELT
Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/78 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
To lay down a Procedure for Cleaning of Conveyor Belt.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE
5.1.
Check electrical terminals for insulation and soundness of terminal connections. Check soundness of electrical switches and its contacts.
5.2.
At the end of the shift the equipment should be cleaned.
5.3.
Check oil in the gearbox and wipe the excess of oil using cotton waste.
5.4.
Wipe the surfaces of conveyor belt and table, using clean dry cloth. Use vacuum cleaner, if required.
5.5.
Moping the surfaces of tabletop and conveyor belt using, 0.5% solution of Teepol. Remove any stains or pieces of gum tape sticked on the surfaces, using clean cloth. Again moping the surfaces repeatedly, using clean cloth dipped in water. Ensure complete removal of detergent. Wipe dry the surfaces using clean dry cloth.
5.6.
Switch on the machine and bring the lower portion of conveyor belt, on the top to facilitate cleaning.
5.7.
Put status label ‘CLEANED’ and date.
TITLE: SOP FOR OPERATION & CLEANING OF BOTTLE Page : 01-03 FILLING MACHINE Deptt.: PRODUCTION SOP No.: SPD/79 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
To lay down a Procedure for Operation and Cleaning of Bottle Filling Machine. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE MACHINE NAME
Bottle Filling Machine
M/C No.: _____________
The entire Machine Operation & Cleaning procedure is divided in three stages. i)
Pre-operative Cleaning & Setting.
ii)
Operation
iii)
Post Operative Cleaning and equipment preparation.
STAGE – I a)
The exterior of the machine is cleaned with dry cloth
b)
The electrical connections are restored by pulling the plug top into the socket.
c)
The “MACHINE READY FOR USE” sticker is removed and sticker/tag showing product Batch No. etc. is put on the top cover of the machine.
d)
The filling syringe inlet pipe fitted with the filling machine is cleaned by D.M. water.
e)
Empty glass bottle kept near the filling machine.
TITLE: SOP FOR OPERATION & CLEANING OF BOTTLE Page : 02-03 FILLING MACHINE Deptt.: PRODUCTION SOP No.: SPD/79 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….……….
STAGE – II a)
The Bottle Filling Machine is switched on and run for few seconds to observe whether it is running normally or not.
b)
If any abnormal sound is heard the machine is referred to maintenance dept. for rectification.
c)
In other case, the machine is started and the liquid is out from the syringe and the volume set as required.
d)
The process is continued until the entire liquid is filled.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE e)
In case of Product or composition change, the entire m/c is washed and wash water analysis is done by Q.C.D. render the m/c ready for further use.
STAGE – III a)
After the day’s operation or Production change or change of composition all the contact parts like inlet and outlet pipe, syringe and nozzle etc. are thoroughly cleaned and wash water is sent to Q.C.D. for testing.
b)
Once the wash water analysis is cleared by Q.C.D. The contact parts and other parts are moped and dried.
c)
The connection is then cut off by taking out the plug top from the socket.
d)
A sticker stating “MACHINE READY FOR USE” is put on the machine to render it ready for use.
A logbook is kept for each machine of operation in the format given in annexure 1
TITLE: SOP FOR OPERATION & CLEANING OF BOTTLE Page : 03-03 FILLING MACHINE Deptt.: PRODUCTION SOP No.: SPD/79 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….……….
ANNEXURE-I LOG BOOK
M/C: BOTTLE FILLING MACHINE Date
Start Time
Finish Time
Total hrs. of running
Machine No.
Breakdown Start
End
Down Time hrs.
Page No.____ Product, Batch No., B. Size, Mfd. & Exp.
Operator & Checked By
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE
TITLE: SOP FOR OPERATION & CLEANING OF BOTTLE Page : 01-03 WASHING MACHINE Deptt.: PRODUCTION SOP No.: SPD/80 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
To lay down a Procedure for Operation and Cleaning of Bottle Washing Machine. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE MACHINE NAME: Jet Bottle Washing Machine
M/C No. :_____________
The entire Machine Operation & Cleaning is divided in three stages. 5.1 Pre-operative Cleaning & Setting. 5.2 Operation 5.3 Post Operative Cleaning and equipment preparation.
STAGE – I a)
The exterior of the machine is cleaned with dry cloth
b)
The electrical connections are restored by pulling the plug top into the socket.
c)
The “Machine Ready for use” sticker is removed and sticker/tag showing product Batch No. etc. is put on the top cover of the machine.
d)
Connect the jet with D. M. Water and check the pressure of the water flow.
TITLE: SOP FOR OPERATION & CLEANING OF BOTTLE Page : 02-03 WASHING MACHINE Deptt.: PRODUCTION SOP No.: SPD/80 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….……….
STAGE – II a)
The Bottle Washing Machine is switched on and run for few seconds to observe whether it is running normally or not.
b)
If any abnormal sound is heard the machine is referred to maintenance dept. for rectification.
c)
In other case the machine is started and the bottle wash with the help of brush.
d)
The brushed bottle is dipped into fresh D. M. Water and then these bottle washed with the jet.
e)
The process is continued until all the bottles are washed.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE f)
In case of Size or product change, the brush is changed.
STAGE – III a)
After the day’s operation or production change or change of composition all the contact parts like brush and containers etc. are thoroughly cleaned by detergent potable water and finally by D. M. Water.
b)
Once the wash water analysis is cleared by Q.C.D. The contact parts and other parts are moped and dried.
c)
The connection is then cut off by taking out the plug top from the socket.
d)
A sticker stating “MACHINE READY FOR USE” is put on the machine to render it ready for use.
A logbook is kept for each machine of operation in the format given in annexure 1
TITLE: SOP FOR OPERATION & CLEANING OF BOTTLE Page : 03-03 WASHING MACHINE Deptt.: PRODUCTION SOP No.: SPD/80 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….……….
ANNEXURE-I LOG BOOK
M/C: JET BOTTLE WASHING MACHINE
Date
Start Time
Finish Time
Total hrs. of running
Breakdown Start
End
Machine No.
Down Time hrs.
Product, Batch No., B. Size, Mfd. & Exp.
Page No._
Operator & Checked By
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE
TITLE: SOP FOR OPERATION & CLEANING OF COLLOIDAL Page : 01-03 MACHINE Deptt.: PRODUCTION SOP No.: SPD/81 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
To lay down a Procedure for Operation and Cleaning of Colloidal Machine. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
MACHINE NAME: Colloidal Mill
M/C No.: _______________
The entire Machine Operation & Cleaning is divided in three stages.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE i)
Pre-operative Cleaning & Setting.
ii)
Operation
iii)
Post Operative Cleaning and equipment preparation.
STAGE – I a.
The exterior of the machine is cleaned with dry cloth
b.
The electrical connections are restored by pulling the plug top into the socket.
c.
The “MACHINE READY FOR USE” sticker is removed and sticker/tag showing product Batch No. etc. is put on the top cover of the machine.
d.
A plastic/S.S. container is kept below the outlet of the M/c.
e.
The container containing the material is brought near the machine.
TITLE: SOP FOR OPERATION & CLEANING OF COLLOIDAL Page : 02-03 MACHINE Deptt.: PRODUCTION SOP No.: SPD/81 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….……….
STAGE – II a.
The colloidal mill is switched on and run for few seconds to observe whether if is running normally or not.
b.
If any abnormal sound is heard the machine is referred to maintenance dept. for rectification.
c.
In other case the machine is started and the liquid is out on the hopper slowly and gradually.
d.
The colloidal liquid is collected in the S.S. container.
e.
The process is continued until the entire liquid is colloid.
f.
If further colloid of the same batch is required it is continued.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE g.
In case of batch changes, the contact parts are cleaned by water and then D.M. water.
STAGE – III a.
After the day’s operation or Production change or change of composition all the contact parts like hopper, pipe and grinding parts are thoroughly cleaned and wash water is sent to Q.C.D. for testing.
b.
Once the wash water analysis is cleared by Q.C.D. The contact parts and other parts are moped and dried.
c.
The connection is then cut off by taking out the plug top from the socket.
d.
A sticker stating “MACHINE READY FOR USE” is put on the machine to render it ready for use.
A logbook is kept for each machine of operation in the format given in annexure 1 TITLE: SOP FOR OPERATION & CLEANING OF COLLOIDAL Page : 03-03 MACHINE Deptt.: PRODUCTION SOP No.: SPD/81 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….……….
ANNEXURE-I LOG BOOK
M/C: COLLOIDAL MILL Date
Start Time
Finish Time
Total hrs. of running
Machine No. Breakdown Start
End
Page No.____ Down Time hrs.
Product, Batch No., B. Size, Mfd. & Exp.
Operator & Checked By
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE
TITLE: SOP FOR OPERATION & CLEANING OF HIGH SPEED Page : 01-03 STIRRER Deptt.: PRODUCTION SOP No.: SPD/82 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
To lay down a Procedure for Operation and Cleaning of High Speed Stirrer. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
MACHINE NAME: High Speed Stirrer
M/C No. :___________
The entire Machine Operation & Cleaning is divided in three stages. 6.1
Pre-operative Cleaning & Setting.
6.2
Operation
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 6.3
Post Operative Cleaning and equipment preparation.
STAGE – I a.
The exterior of the machine is cleaned with dry cloth
b.
The electrical connections are restored by pulling the plug top into the socket.
c.
The “MACHINE READY FOR USE” sticker is removed and sticker/tag. showing product Batch No. etc. is put on the top cover of the machine.
d.
The S.S. Drum 1000 or 500 Lts. fitted with stirrer. Stirring rod fitted with stirrer and solution kept into S.S. Drum.
TITLE: SOP FOR OPERATION & CLEANING OF HIGH SPEED Page : 02-03 STIRRER Deptt.: PRODUCTION SOP No.: SPD/82 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….……….
STAGE – II a.
The High Speed Stirrer is switched on and run for few seconds to observe whether it is running normally or not.
b.
If any abnormal sound is heard, the machine is referred to maintenance dept. for rectification.
c.
In other case, the machine is started slow check the machine.
d.
The stirring continue until the mass mixed properly.
e.
In case of batch changes, the contact parts are cleaned with water.
f.
In case of Product or composition change, the entire machine is washed and wash water analysis is to be done to by Q.C.D. render the machine ready for further use.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE STAGE – III a.
After the day’s operation or Production change or change of composition all the contact parts like mixing blade & shaft are thoroughly cleaned and washed. Final washing to be done by D.M water and wash water is sent to Q.C.D. for testing.
b.
Once the wash water analysis is cleared by Q.C.D. The Mass Mixer surface (inner & outer), cover, blade shaft etc. are moped and dried.
c.
The connection is then cut off by taking out the plug top from the socket.
d.
A sticker stating “MACHINE READY FOR USE” is put on the machine to render it ready for use.
TITLE: SOP FOR OPERATION & CLEANING OF HIGH SPEED Page : 03-03 STIRRER Deptt.: PRODUCTION SOP No.: SPD/82 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. A logbook is kept for each machine of operation in the format given in annexure 1
ANNEXURE-I LOG BOOK M/C: HIGH SPEED STIRRER Date
Start Time
Finish Time
Total hrs. of running
Machine No. Breakdown Start
End
Page No.____ Down Time hrs.
Product, Batch No., B. Size, Mfd. & Exp.
Operator & Checked By
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE
TITLE: SOP FOR OPERATION & CLEANING OF FILTER Page : 01-03 PRESS Deptt.: PRODUCTION SOP No.: SPD/83 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
To lay down a Procedure for Operation and Cleaning of Filter Press. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
MACHINE NAME: Filter Press
M/C No. :_______________
The entire Machine Operation & Cleaning is divided in three stages. 6.1
Pre-operative Cleaning & Setting.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 6.2
Operation
6.3
Post Operative Cleaning and equipment preparation.
STAGE – I a)
The exterior of the machine is cleaned with dry cloth
b)
The electrical connections are restored by pulling the plug top into the socket.
c)
The “MACHINE READY FOR USE” sticker is removed and sticker/tag showing product Batch No. etc. is put on the top cover of the machine.
d)
The inlet pipe is connected with filtering liquid and outlet pipe with reservoir tank.
e)
The filter liquid is contained in to S.S. tank.
f)
The container containing the filter liquid brought near the machine.
TITLE: SOP FOR OPERATION & CLEANING OF FILTER Page : 02-03 PRESS Deptt.: PRODUCTION SOP No.: SPD/83 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….……….
STAGE – II
a)
The Filter Press is switched on and run for few seconds to observe whether if is running normally or not.
b)
If any abnormal sound is heard the machine is referred to maintenance dept. for rectification.
c)
In other case the machine is started and the liquid is out throw out let pipe slowly and gradually.
d)
The filter liquid is contained in to S.S. tank.
e)
The process is continued until the entire liquid filter.
f)
If further filtration of the same batch is required it’s continued.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE g)
In case of batch changes, the contact parts are cleaned by D.M water and wash water analysis is to be done by Q.C.D. render the machine ready for the use.
STAGE – III
a)
After the day’s operation or Production change or change of composition all the contact parts like filter pads, pipe and filter assembly etc. are thoroughly cleaned and wash water is sent to Q.C.D. for testing.
b)
Once the wash water analysis is cleared by Q.C.D. The contact parts and other parts are moped and dried.
c)
The connection is then cut off by taking out the plug top from the socket.
d)
A sticker stating “MACHINE READY FOR USE” is put on the machine to render it ready for use.
TITLE: SOP FOR OPERATION & CLEANING OF FILTER Page : 03-03 PRESS Deptt.: PRODUCTION SOP No.: SPD/83 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. A logbook is kept for each machine of operation in the format given in annexure 1
ANNEXURE-I LOG BOOK Machine Name: Filter Press Date
Start Time
Finish Time
Machine No. __________
Total hrs. of running
Breakdown Start
End
Down Time hrs.
Page No.____ Product, Batch No., B. Size, Mfd. & Exp.
Operator & Checked By
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE
TITLE: SOP FOR OPERATION & CLEANING OF PP CAP Page : 01-03 SEALING MACHINE Deptt.: PRODUCTION SOP No.: SPD/84 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
MACHINE NAME :
To lay down a Procedure for Operation and Cleaning of P.P. Cap Sealing Machine. Q/C Manager.
P. P. Cap Sealing Machine
M/C No. :____________
The entire Machine Operation & Cleaning is divided in three stages. 6.1
Pre-operative Cleaning & Setting.
6.2
Operation
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 6.3
Post Operative Cleaning and equipment preparation.
STAGE – I a)
The exterior of the machine is cleaned with dry cloth
b)
The electrical connections are restored by pulling the plug top into the socket.
c)
The “MACHINE READY FOR USE” sticker is removed and sticker/tag showing product Batch No. etc. is put on the top cover of the machine.
d)
Bottle guides to adjust sealing machine according to the size of the bottle.
e)
The machine shifted near the filling machine for easy handling of the bottle.
TITLE: SOP FOR OPERATION & CLEANING OF PP CAP Page : 02-03 SEALING MACHINE Deptt.: PRODUCTION SOP No.: SPD/84 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….……….
STAGE – II
a)
The P. P.Cap sealing Machine is switched on and run for few seconds to observe whether it is running normally or not.
b)
If any abnormal sound is heard the machine is referred to maintenance dept. for rectification.
c)
In other case the machine is started and check the sealing and threading of the P. P. Caps.
d)
If the seal is abnormal, set the sealing and threading roller.
e)
The process is continued until all the bottles are sealed.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE STAGE – III
a)
After the day’s operation or Production change or change of composition all the contact parts like rubber pad and sealing head etc. are thoroughly cleaned with water and moped with dry cloth.
b)
The connection is then cut off by taking out the plug top from the socket.
c)
A sticker stating “MACHINE READY FOR USE” is put on the machine to render it ready for use.
TITLE: SOP FOR OPERATION & CLEANING OF PP CAP Page : 03-03 SEALING MACHINE Deptt.: PRODUCTION SOP No.: SPD/84 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. A logbook is kept for each machine of operation in the format given in annexure 1 ANNEXURE-I LOG BOOK
M/C: PP CAP SEALING MACHINE Date
Start Time
Finish Time
Total hrs. of running
Machine No. Breakdown
Start
End
Down Time hrs.
Page No.____ Product, Batch No., B. Size, Mfd. & Exp.
Operator & Checked By
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE
TITLE: SOP FOR VISUAL INSPECTION OF LIQUID ORALS
Page : 01-02 Deptt.: PRODUCTION SOP No.: SPD/85 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1.
To lay down a Procedure for Visual Inspection of Orals Liquid. Q/C Manager.
Inspection of filled unit in front of illuminated light for following type of foreign particle:
a.
Black Particle on white background.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE b.
White Particle on black background.
c.
Glass Particle on black background.
d.
Rubber Particle on black background.
e.
Fibers on black background.
5.2
After checking of these particle on inspection board unit are to be sent for labeling & packing after getting O.K. report from Q.C. Dept.
5.3
Units with particles are to be kept aside for rejection.
5.4
The Status Label of rejection are kept with rejection containers.
5.5
The OK material is transfer in approved quarantine alongwith the status label.
5.6
Record is to be maintained stating the date, name of inspectors, rejection (as fibred, glass particle, black & white particle) breakage and damage seal, percentage of rejection.
TITLE: SOP FOR VISUAL INSPECTION OF LIQUID ORALS
Page : 02-02 Deptt.: PRODUCTION SOP No.: SPD/85 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….……….
RECORD OF INSPECTION OF BOTTLE/AMPOULES Product:
Mfg Date.:
Batch No.:
Exp. Date:
Qty of Bottle Received for visual inspection: Date of Inspected Rejection Rejection Rejection Rejection Breakage Insp. By glass Fiber Black White particles particles particles
Damage seal
% of Rejection
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE
Signature of Production Manager
TITLE: SOP FOR CLEANING OF S.S TANKS & STIRRER Page : 01-01 (LIQUID SECTION) Deptt.: PRODUCTION SOP No.: SPD/86 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
To lay down a Procedure for Cleaning of S.S. Tanks and Stirrer (Liquid Section). Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1.
Transfer the tanks with stirrer in the washing area.
5.2.
Keep aside the lid and other part of tanks.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.3.
Flush the tank and stirrer with D.M. Water. Scrub with 0.1% Teepol solution using nylon brush. Wash the lid similarly.
5.4.
Wash with D.M. Water to remove all traces of the detergent.
5.5.
Again rinse with D.M. water and drain off completely. Fix the lid properly.
5.6.
Washing to be monitor by Q.A. Manager regularly.
5.7.
Affix a status label “CLEAN” and date.
TITLE: SOP FOR MIXING, GRANULATION & PUNCHING
Page : 01-02 Deptt.: PRODUCTION SOP No.: SPD/87 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
To lay down a Procedure for Mixing, Granulation and Punching. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1.
Take the active & non-active contents on per product requirement mention in R.M. Requisition.
5.2.
Before starting, ensure that the every bag is properly tagged from store department.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.3.
Cross, check the wt. of every bag.
5.4.
Check the cleaning of granulation area.
5.5.
Shift all active & non-active material by sifter.
5.6.
Ensure that all equipments are ready to use.
5.7.
Transfer the materials in mass mixer for dry mixing as mention in master formula.
5.8.
Rotate the mass mixer as the time mention in master formula.
5.9.
Prepare the binder.
5.10.
Add the binder in mass mixer & rotate as the dens mass is formed.
TITLE: SOP FOR MIXING, GRANULATION & PUNCHING
Page : 02-02 Deptt.: PRODUCTION SOP No.: SPD/87 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 5.11.
Pass the mass through multimill.
5.12.
Dry the granules in FBD as the temperature & time mention in master formula.
5.13.
When the moisture content is below 2% unload the granule & add lubricants in granules as mention in master formula.
5.14.
Transfer the granules in drums & check the wt. & drop the job card in drum.
5.15.
Send granules for bulk analysis.
5.16.
After getting the Q.C. report OK. Send the granules for compression.
5.17.
Before starting the compression ensure the cleaning & wash water analysis report.
5.18.
Start the compression & check the hardness & wt. variation of tablet.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.19.
After getting OK the in process report starts the compression.
TITLE: SOP FOR STRIP VISUAL INSPECTION
Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/88 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
To lay down a Procedure for Strip Visual Inspection.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1.
Transfer the strips in visual inspection area
5.2.
Check the status card & job card in container.
5.3.
Check the line clearance of visual checking belt.
5.4.
Spread the strips on visual belt.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.5.
Check the stripping quality with respect of cutting. It should be sharp & straight.
5.6.
Check the printing quality of B.No, Mfg. Date, Exp. Date & MRP. The ink should not be spread on the strips.
5.7.
The cavity should not have any cut as the strips.
TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 01-06 COMPRESSION MACHINE (ROTARY MACHINE) Deptt.: PRODUCTION SOP No.: SPD/89 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1
To lay down a Procedure for Operation and Cleaning of Tablet Compression Machine (Rotary Machine). Q/C Manager.
PRE START UP: 5.1.1
Check the Equipment Usage and Cleaning Log and ensure that equipment cleaning operation has been recorded.
5.1.2
Visually check the equipment and area for its cleanliness.
5.1.3
Check the temperature, relative humidity and differential pressure of the area and record the details in respective logbooks.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.1.4
If the conditions are not within the limit, do not start the operation and inform to the Engineering department.
5.1.5
If the conditions are within the limit, then start the operation.
5.1.6
Ensure that the dies punches fitted in the machine are as per the product specification in the Batch Manufacturing Record.
5.1.7
Check that punches are free in punch guide and upper punches dropped under their own weight.
5.1.8
Lubricate the machine with food grade lubricant.
5.1.9
Turn the hand wheel in clockwise direction for two to three rotations. Ensure that turret rotates smoothly.
5.1.10 Affix the status label on the equipment. TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 02-06 COMPRESSION MACHINE (ROTARY MACHINE) Deptt.: PRODUCTION SOP No.: SPD/89 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 5.1.11 Get the approval from In Process Quality Assurance Manager to start the operation. 5.1.12 Ensure that balance to be used for weighing is calibrated, by checking the balance calibration record. 5.1.13 Ensure the batch identity, status and weight of the bulk, which is to be compressed as per the “INPROCESS STAGE” label affixed on the Intermediate Product Container. 5.1.14 Check the signature of Inprocess Quality Assurance Manager in the approved by column of “INPROCESS STAGE” label of Intermediate Product Container. 5.1.15 Load the bulk to be compressed in the hopper of machine. 5.1.16 Bring the polythene lined high-density polyethylene container in the compression room for the storage of tablets. 5.2
OPERATION: 5.2.1
Switch “ON” the main electric supply of the machine.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.2.2
Set the desired hydraulic pressure of machine.
5.2.3
Take a polythene lined high-density polyethylene container and put the “CONTAINER STATUS” label on it.
5.2.4
Weigh the container and write Tare weight of container on the “CONTAINER STATUS” label.
5.2.5
Place the duly labeled polythene bag lined high-density polyethylene container below the discharge chute of compression machine, for collection of the compressed tablets.
5.2.6
Operate the machine in “INCH” mode to check the smooth running of machine.
5.2.7
Start the feeder switch to fill the powder in the feeder.
TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 03-06 COMPRESSION MACHINE (ROTARY MACHINE) Deptt.: PRODUCTION SOP No.: SPD/89 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 5.2.8
Switch “ON” the machine by pressing green push button.
5.2.9
Run the machine for two minutes.
5.2.10 Check the tablets for weight variation, thickness, hardness, friability, disintegration time and other parameters as specified in Batch Manufacturing Record. 5.2.11 Adjust the parameters to the desired specifications as specified in Batch Manufacturing Record. 5.2.12 After achieving desired parameters, stop the machine. 5.2.13 Inform In-process quality assurance officer to collect the sample for dissolution test, if required or as specified in Batch Manufacturing Record. 5.2.14 Remove the high-density polyethylene container in which the tablets are collected and keep it aside on the container trolly. 5.2.15 Replace the “CONTAINER STATUS” label of polyethylene container with “RECOVERABLES” label.
high-density
5.2.16 Tear off the “CONTAINER STATUS” label after confirming the details on it and put it in the waste bin.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.2.17 Place the “TABLET DE-DUSTER” exactly below the discharge chute of compression machine. 5.2.18 Take a fresh polythene lined high-density polyethylene container and put the “CONTAINER STATUS” label on it. 5.2.19 Weigh the container and write Tare weight of container on the “CONTAINER STATUS” label. 5.2.20 After getting approval from Quality Assurance Manager, start the operation. 5.2.21 Record the operation start time in equipment usage and cleaning log and in Batch Manufacturing Record. TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 04-06 COMPRESSION MACHINE (ROTARY MACHINE) Deptt.: PRODUCTION SOP No.: SPD/89 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 5.2.22 Inform the In-Process Quality Assurance Officer to check the parameters. 5.2.23 Check the compressed tablets for In-process test parameters at regular intervals as specified in Batch Manufacturing Record and record the details in In-process Control Chart. 5.2.24 After the high-density polyethylene container is filled, replace it with another polythene lined high-density polyethylene container. 5.2.25 Take the gross weight of filled container and record the details on “CONTAINER STATUS” label, tie the polythene bag with tie band and keep the container on container trolly. 5.3
SHUT DOWN 5.3.1
After completion of operation switch “OFF” the machine by pushing the red button.
5.3.2
Release the pressure in hydraulic system.
5.3.3
Switch “OFF” the main electric supply of machine.
5.3.4
Transfer the filled tablet containers and recoverables container to the respective place.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.3.5
In case of day end compression (compression operation of batch not completed), transfer the bulk, remaining for compression, to the Intermediate Product Container and transfer to respective place.
5.3.6
Remove the status label from the equipment, tear it off, and put in the waste bin.
5.3.7
Affix duly filled “TO BE CLEANED” label on the equipment.
TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 05-06 COMPRESSION MACHINE (ROTARY MACHINE) Deptt.: PRODUCTION SOP No.: SPD/89 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 5.4
CLEANING: 5.4.1
5.4.2
AT THE TIME OF DAY END AND BATCH CHANGE OVER: 5.4.1.1
Remove the “TO BE CLEANED” Label from the equipment. Tear the label after checking the details on it.
5.4.1.2
Record the cleaning start time in the equipment usage and cleaning log.
5.4.1.3
Clean the punches and dies by vacuum cleaner.
5.4.1.4
Clean the machine by dry lint free cloth.
5.4.1.5
Clean throughly, compression machine after every 3 batches as mentioned in 5.4.2.
AT THE TIME OF PRODUCT CHANGE OVER: 5.4.2.1
Remove the dies, punches from machine, and dipped in 70% Isopropyl Alcohol for cleaning.
5.4.2.2
Dry the dies and punches with lint free cloth.
5.4.2.3
Lubricate the dies and punches with food grade oil and transfer to the respective place.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.4.2.4
Remove the change parts of the machine and send to the equipment washing area.
5.4.2.5
Clean the parts with raw water and ensure that the parts are visually clean.
5.4.2.6
Clean the parts with 0.1 % w/v of Teepol solution & flush with plenty of raw water to remove traces of Teepol solution.
5.4.2.7
Finally clean the parts with purified water.
TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 06-06 COMPRESSION MACHINE (ROTARY MACHINE) Deptt.: PRODUCTION SOP No.: SPD/89 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 5.4.2.8
Clean the machine body using lint free cloth dipped in potable water followed by dry lint free cloth.
5.4.2.9
Send the rinse water-sampling request to the Quality Assurance department to collect the rinse water sample for analysis of traces as per respective standard operating procedure.
5.4.2.10
Dry the parts using dryer.
5.4.2.11
Record the cleaning details in equipment usage and cleaning log and in area cleaning log.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE
TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 01-06 COMPRESSION MACHINE (MULTIPUNCHING MACHINE) Deptt.: PRODUCTION SOP No.: SPD/90 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
To lay down a Procedure for Operation and Cleaning of Tablet compression Machine (Multipunch Machine). Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1 PRE START UP: 5.1.1
Check the Equipment Usage and Cleaning Log and ensure that equipmentcleaning operation has been recorded.
5.1.2
Visually check the equipment and area for its cleanliness.
5.1.3
Check the temperature, relative humidity and differential pressure of the area and record the details in respective logbooks.
5.1.4
If the conditions are not within the limit, do not start the operation and inform to the Engineering department.
5.1.5
If the conditions are within the limit, then start the operation.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.1.6
Ensure that the dies punches fitted in the machine are as per the product specification in the Batch Manufacturing Record.
5.1.7
Check that punches are free in punch guide and upper punches dropped under their own weight.
5.1.8
Lubricate the machine with food grade lubricant.
5.1.9
Turn the hand wheel in clockwise direction for two to three rotations. Ensure that turret rotates smoothly.
5.1.10 Affix the status label on the equipment. TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 02-06 COMPRESSION MACHINE (MULTIPUNCHING MACHINE) Deptt.: PRODUCTION SOP No.: SPD/90 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 5.1.11 Get the approval from In-Process Quality Assurance Manager to start the operation. 5.1.12 Ensure that balance to be used for weighing is calibrated, by checking the balance calibration record. 5.1.13 Ensure the batch identity, status and weight of the bulk, which is to be compressed as per the “INPROCESS STAGE” label affixed on the Intermediate Product Container. 5.1.14 Check the signature of Inprocess Quality Assurance Manager in the approved by column of “INPROCESS STAGE” label of Intermediate Product Container. 5.1.15 Load the bulk to be compressed in the hopper of machine. 5.1.16 Bring the polythene lined high-density polyethylene container in the compression room for the storage of tablets. 5.2 OPERATION: 5.2.1
Switch “ON” the main electric supply of the machine.
5.2.2
Set the desired hydraulic pressure of machine.
5.2.3
Take a polythene lined high-density polyethylene container and put the “CONTAINER STATUS” label on it.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.2.4
Weigh the container and write Tare weight of container on the “CONTAINER STATUS” label.
5.2.5
Place the duly labeled polythene bag lined high-density polyethylene container below the discharge chute of compression machine, for collection of the compressed tablets.
5.2.6
Operate the machine in “INCH” mode to check the smooth running of machine.
5.2.7
Start the feeder switch to fill the powder in the feeder.
TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 03-06 COMPRESSION MACHINE (MULTIPUNCHING MACHINE) Deptt.: PRODUCTION SOP No.: SPD/90 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 5.2.8
Switch “ON” the machine by pressing green push button.
5.2.9
Run the machine for two minute.
5.2.10 Check the tablets for weight variation, thickness, hardness, friability, disintegration time and other parameters as specified in Batch Manufacturing Record. 5.2.11 Adjust the parameters to the desired specifications as specified in Batch Manufacturing Record. 5.2.12 After achieving desired parameters, stop the machine. 5.2.13 Inform In-process quality assurance officer to collect the sample for dissolution test, if required or as specified in Batch Manufacturing Record. 5.2.14 Remove the high-density polyethylene container in which the tablets are collected and keep it aside on the container trolley. 5.2.15 Replace the “CONTAINER STATUS” label of polyethylene container with “RECOVERABLES” label.
high-density
5.2.16 Tear off the “CONTAINER STATUS” label after confirming the details on it and put it in the waste bin. 5.2.17 Place the “Tablet De-duster” exactly below the discharge chute of compression machine.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.2.18 Take a fresh polythene lined high-density polyethylene container and put the “CONTAINER STATUS” label on it. 5.2.19 Weigh the container and write Tare weight of container on the “CONTAINER STATUS” label. 5.2.20 After getting approval from Quality Assurance Manager, start the operation. 5.2.21 Record the operation start time in equipment usage and cleaning log and in Batch Manufacturing Record. TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 04-06 COMPRESSION MACHINE (MULTIPUNCHING MACHINE) Deptt.: PRODUCTION SOP No.: SPD/90 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 5.2.22 Inform the In Process Quality Assurance Officer to check the parameters. 5.2.23 Check the compressed tablets for In-process test parameters at regular intervals as specified in Batch Manufacturing Record and record the details in In process Control Chart. 5.2.24 After the high-density polyethylene container is filled, replace it with another polythene lined high-density polyethylene container. 5.2.25 Take the gross weight of filled container and record the details on “CONTAINER STATUS” label, tie the polythene bag with tie band and keep the container on container trolley. 5.3 SHUT DOWN: 5.3.1
After completion of operation switch “OFF” the machine by pushing the red button.
5.3.2
Release the pressure in hydraulic system.
5.3.3
Switch “OFF” the main electric supply of machine.
5.3.4
Transfer the filled tablet containers and recoverables container to the respective place.
5.3.5
In case of day end compression (compression operation of batch not completed), transfer the bulk, remaining for compression, to the Intermediate Product Container and transfer to respective place.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.3.6
Remove the status label from the equipment, tear it off, and put in the dustbin.
5.3.7
Affix duly filled “TO BE CLEANED” label on the equipment.
TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 05-06 COMPRESSION MACHINE (MULTIPUNCHING MACHINE) Deptt.: PRODUCTION SOP No.: SPD/90 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 5.4
CLEANING: 5.4.1
AT THE TIME OF DAY END AND BATCH CHANGE OVER: 5.4.1.1
Remove the “TO BE CLEANED” Label from the equipment. Tear the label after checking the details on it.
5.4.1.2
Record the cleaning start time in the equipment usage and cleaning log.
5.4.1.3
Clean the punches and dies by vacuum cleaner.
5.4.1.4
Clean the machine by dry lint free cloth.
5.4.1.5 5.4.2
Clean thoroughly, compression machine after every three batches as mentioned in 5.4.2.
AT THE TIME OF PRODUCT CHANGE OVER: 5.4.2.1 5.4.2.2
Remove the dies, punches from machine, and dipped in 70% v/v Isopropyl Alcohol for cleaning. Dry the dies and punches with lint free cloth.
5.4.2.3
Lubricate the dies and punches with food grade oil and transfer to the respective place.
5.4.2.4
Remove the change parts of the machine and send to the equipment washing area.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.4.2.5
Clean the parts with raw water and ensure that the parts are visually clean.
5.4.2.6
Clean the parts with 0.1 % w/v of Teepol solution & flush with plenty of raw water to remove traces of Teepol solution.
5.4.2.7
Finally clean the parts with purified water.
TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 06-06 COMPRESSION MACHINE (MULTIPUNCHING MACHINE) Deptt.: PRODUCTION SOP No.: SPD/90 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 5.4.2.8
Clean the machine body using lint free cloth dipped in potable water followed by dry lint free cloth.
5.4.2.9
Send the rinse water-sampling request to the Quality Assurance department to collect the rinse water sample for analysis of traces as per respective standard operating procedure.
5.4.2.10
Dry the parts using dryer.
5.4.2.11
Record the cleaning details in equipment usage and cleaning log and in area cleaning log.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE
TITLE: SOP FOR OPERATION OF TUBE FILLING, SEALING, Page : 01-02 CLEANING, CRIMPING & BATCH CODING Deptt.: PRODUCTION MACHINE (TOPICAL SECTION) SOP No.: SPD/91 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
To lay down a Procedure for Operation of Tube Filling, Sealing, Cleaning, Crimping and Batch Coding Machine (Topical Section). Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
Cleaning:-
1.
Dismantle the hopper & filling nozzle & clean it throughly with jet of water. Use 0.2% teepol solution to remove the deposited medicine.
2.
Rinse twice with tap water followed by twice with purified water IP.
3.
Clean machine body & other parts of the machine, (which cannot be detached) with a wet cloth followed by a dry cloth.
4.
Request Q.C. Dept. to withdraw sample of wash water. Put “CLEAN” equipment tag after getting approval from Q.C. Dept.
OPERATION:1.
Load the ointment (to be filled) in the hopper.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 2.
Adjust weight, folding & crimping & start filling operation.
3.
Check weights / Crimping & batch coding every 45 minutes.
TITLE: SOP FOR OPERATION OF TUBE FILLING, SEALING, Page : 02-02 CLEANING, CRIMPING & BATCH CODING Deptt.: PRODUCTION MACHINE (TOPICAL SECTION) SOP No.: SPD/91 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. A)
Tube Filling: - Load clean tubes in the filling trays fill the hopper of filling machine with product and cover it. Fit filling nozzle of appropriate size, set fill weight as per requirement. Run the machine for 2 minutes but do not fill the product in the tubes. After 2 minutes, check average weight per stroke .Adjust if necessary.
B)
Crimping :- Crimp each tube , check the finishing of crimped tubes regularly & also ensure that tubes don't get pressurized during crimping.
C)
Batch Coding: - Set the batch No, print it on the tube and cross check with the B.P.R . The print must be clear.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE
TITLE: SOP FOR INSPECTION, CLEANING & PACKING OF Page : 01-01 TUBES Deptt.: PRODUCTION SOP No.: SPD/92 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
To lay down a Procedure for Inspection, Cleaning and Packing of Tubes. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
Introduction: The base of the cream and ointments is generally petroleum. Paint is soluble in petroleum bases. During filling and other process of mfg., some amount of cream sticks to the outer surfaces of tubes. If this cream is not removed early, the paint on the outer side of the tube may come off. It is therefore necessary to clean the tube as early as possible after filling. CLEANING & INSPECTION: - Inspect each filled tube individually. Reject the tube with following characteristics: 1.
Printing and paint has peeled off.
2.
Tube is punctured.
3.
Crimping is not proper.
4.
Batch No. & Mfg. DT. It not displayed clearly.
5.
Empty tubes, low weight tubes.
6.
Collapsed tubes.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Put “RED COLOUR” identification tag in the rejected tubes tray COLOUR” identification tag in the approved tubes tray.
and “GREEN
PROCEDURE: Take a damp cloth & clean the tube surface followed by cleaning with a dry cloth. Check that tubes paint & printing is not damaged during cleaning. Pack the tube in the unit carton or as described in this master formula. TITLE: SOP FOR BATCH DESTRUCTION
Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/93 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
To lay down a Procedure for Batch Destruction.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
(A)
(B)
PARENTERAL SECTION: 1.
Destruction of batches failing in sterility: - The batches failing in sterility are autoclaved or D.H.S in case of oily prepn. Before destruction.
2.
Destruction of batches due to other reasons: - The ampoules, bottles are broken & solution drained in the sewer. Toxic batches are neutralised before destruction.
EXTERNAL APPLICATION SECTION: 1.
Remove the preparation from the tube.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 2.
Dig & bury the cream underground.
TITLE: SOP FOR CLEANING AND OPERATION OF Page : 01-02 PLANETARY MIXER Deptt.: PRODUCTION SOP No.: SPD/94 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
To lay down a Procedure for Cleaning and Operation of Palnetary Mixer Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
INTRODUCTION: - Planetary mixer is used for preparing batches of creams, ointments & gels etc. It is called planetary mixer due to its rotation which resembles that of planets. (Planets revolve on their axis and also around sun.) This mixer is used to prepare homogeneous batches of Semi Solid nature. Construction: - Planetary mixer consists of a motor, a gearbox to control speed of stirrer, a jacketed tank, stirring blade, a handle to move tank up and down and a lid to cover the tank. Operation:1.
Take the jacketed tank and load it on the mixer.
2.
Assemble the stirrer blade inside the tank and place items to be mixed in the tank
3.
Raise the tank by moving the handle clockwise to fit the tank on the lid .
4.
Switch on motor by pressing green button on the starter. Now motor is in neutral gear. Shift the gear as the speed required i.e. first gear, IInd gear or IIIrd gear.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.
Pass hot or cold water through the jacket of stirrer if required.
6.
Switch off the stirrer when mixing is complete by pushing red button on the starter.
7.
Bring the tank down by rotating the handle anticlockwise. Remove tank & stirrer blade from the stand and cover them.
TITLE: SOP FOR CLEANING AND OPERATION OF Page : 02-02 PLANETARY MIXER Deptt.: PRODUCTION SOP No.: SPD/94 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. Cleaning of Planetary Mixer: Requirements: 1.
Fibre free plastic brush.
2.
50 Ltrs D.M. water I.P.
3.
10 Ltrs Hot water (60oC).
4.
2 Ltrs 2% Teepol soln. (40 ml teepol + q.s. 2 ltrs water)
Procedure: 1.
Hose down sides of the tank, stirrer shaft & blades and lid of the tank with tap water. Drain the water.
2.
Scrub tank, shaft blades etc with teepol solution & brush. Use hot water to remove deposited material.
3.
Rinse all parts with tap water thrice.
4.
Drain the water & rinse tank with D.M. water I.P. and ask Q.C.Deptt to withdraw sample of wash water and give test report.
5.
Keep mixer covered with lid.
6.
Make entry in equipment logbook.
7.
Put “CLEAN” equipment tag on the mixer when lab approves the wash water.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE
TITLE: SOP FOR CLEANING, OPERATION & Page : 01-01 MAINTENANCE OF COLLOIDAL MILL Deptt.: PRODUCTION SOP No.: SPD/95 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
To lay down a Procedure for Cleaning, Operation and Maintenance of Colloidal Mill. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
CLEANING:-
1.
Detach hopper and wash with 0.2% teepol solution rinse with several washes of water. Fit it back to its position.
2.
Fill water in hopper & operate the machine so that medicine in the grinding slit is also removed .Drain the water.
3.
Take hot water & repeat the above process. Drain the water.
4.
Take purified water IP in the hopper & run the machine for 2 minutes. Drain the water.
5.
Refill purified water IP in the hopper & run the machine for 2 minutes .Request Q.C Deptt. to withdraw sample of wash water.
6.
Put clean equipment tag in the machine after getting approval from Q.C Dept.
OPERATION:1.
Check direction of rotation of mill, it must be clock wise.
2.
Fill the hopper with liquid & start milling.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 3.
In case the mill stops abruptly switch it off. Enlarge the grinding slit & restart.
4.
Switch off the machine after completion of milling.
TITLE: SOP FOR WASHING & CLEANING OF EQUIPMENTS Page : 01-01 (EXTERNAL PREPARATION SECTION) Deptt.: PRODUCTION SOP No.: SPD/96 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
To lay down a Procedure for Washing and Cleaning of Equipments (External Preparation Section). Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1
Wash down sides of the tank, stirrer shaft & blades and lid of the tank with tap water. Drain the water.
5.2
Scrub tank, shaft blades etc with teepol solution & brush. Use hot water to remove deposited material.
5.3
Rinse all parts with tap water thrice.
5.4
Drain the water & rinse tank with purified water I.P. and ask Q.C.Deptt to withdraw sample of wash water and give test report.
5.5
Keep mixer covered with lid.
5.6
Make entry in equipment log book.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 5.7
Put clean equipment tag on the mixer when lab approves the wash water.
TITLE: SOP FOR BATCH PREPARATION OF EXTERNAL Page : 01-02 PREPARATION Deptt.: PRODUCTION SOP No.: SPD/97 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
To lay down a Procedure for Batch Preparation of External Preparation. Q/C Manager.
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
Three types of batches are prepared in external application section viz:
1.)
Cream
2.)
Ointment
3.)
Liquid e.g. Shampoo, Gum-Paint etc.
5.1 PROCEDURE FOR CREAM:1.1.1
Heat aqueous base in S.S. tank by LP G gas stove .
1.1.2
Heat oily base in S.S. tank by LPG gas stove
1.1.3
Add any raw material to above phases as per direction given in MFR.
1.1.4
Filter the oily phase into planetary mixer tank.
1.1.5
Now filter aqueous phase into planetary mixer tank.
1.1.6
Switch on planetary mixer & continue till cream formation tanks place. This will take 6-7 hours in summer & 3-4 hours in winter.
1.1.7
Add any leftover Raw material.
1.1.8
Check weight of batch add purified water to make up weight.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 1.1.9
After all the ingredients has been added & weight of batch has been made upto mark switch on shrives & continue for minimum one hour.
1.1.10 Pass the batch through colloid mill, send sample for bulk analysis. TITLE: SOP FOR BATCH PREPARATION OF EXTERNAL Page : 02-02 PREPARATION Deptt.: PRODUCTION SOP No.: SPD/97 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1.2
PROCEDURE FOR OINTMENT:As the Ointment generally do not contain water. Protect the batch from water. Use dry equipment only.
5.3
A.
Take the base in S.S. container & heat to melt.
B.
Add raw material as per MFR shrive.
C.
The batch with a scoop till solidifier.
D.
Check WFI batch & send sample for bulk analysis.
PROCEDURE FOR LIQUIDS:-
A.
Take measured quantity of base in the S.S. table
B.
Add raw material as per MFR & shrive.
C.
Make up volume & send sample for bulk analysis.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE
TITLE: SOP FOR WASHING, CLEANING & STORAGE OF Page : 01-02 EQUIPMENT,VESSELS, STIRRER & MACHINE Deptt.: PRODUCTION PARTS FOR OINTMENT & CREAM SOP No.: SPD/98 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1)
PURPOSE
:
2)
RESPONSIBILITY
:
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
REQUIREMENTS
:
6.
To lay down a Procedure for Washing, Cleaning and Storage of Equipment, Vessels, Stirrer and Machine Parts for Ointment and Cream. Q/C Manager.
5.1
0.2% Teepol solution.
5.2
Scrubbing brush.
5.3
Potable water
5.4
Purified water
5.5
Water for injection.
5.6
Butter paper & rubber bands.
PROCEDURE: Following steps are involved:
6.1 EQUIPMENT DISASSEMBLY: - Equipment or machine parts like syringe should be completely disassembled to render complete cleaning .
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 6.2 PRE-WASH: - Collect all the vessels to be washed in the washing section & sprinkle hot water over them. Keep equipment & machine parts in hot water for 30 minutes. TITLE: SOP FOR WASHING, CLEANING & STORAGE OF Page : 02-02 EQUIPMENT,VESSELS, STIRRER & MACHINE Deptt.: PRODUCTION PARTS FOR OINTMENT & CREAM SOP No.: SPD/98 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 6.3 SCRUBBING: - With a plastic brush soaked in 0.2% teepol solution, scrub all equipments to remove stains, medicine depositions etc.
6.4 INITIAL RINSE: - Rinse with potable water until they are free from teepol.
6.5 FINAL RINSE: - Rinse all washed articles twice each with purified water followed by water for injection.
6.6 WASH WATER ANALYSIS: - Request Q.C. Dept to withdraw sample of wash water & send their results for the testing of detergent & last batch traces. Put clean equipment tag after getting approval from Q.C Dept.
7.
STORAGE OF CLEAN EQUIPMENTS: - After completion of washing, washed articles should be stored under conditions, which minimize the risk of contamination by particulate matter & after sterilization by viable organisms. To the extent, possible components should be covered with lid or with butter paper or aluminum foils.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE
TITLE: SOP FOR COATING PAN
Page : 01-02 Deptt.: PRODUCTION SOP No.: SPD/99 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1.
PURPOSE
:
To lay down a Procedure for Coating Pan.
2.
RESPONSIBILITY
:
Q/C Manager.
3.
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4.
SCOPE
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5.
PROCEDURE:
:
MACHINE NAME: COATING PAN
M/C No.:
Loading weighed quantity of uncoated tablets:- Load weighed quantity of uncoated tablets from the containers into the coating pan. Operation:1)
Coating Pan
2)
Exhaust System
3)
Hot air blower a)
Ensure the working and effectiveness of exhaust system and the hot air blower.
b)
Arrange the position of hot air blower and exhaust system.
c)
Carry out coating operation as per the standard procedure laid down in the product BMR. Following parameters must be strictly adhered to: 1)
Required temperature of the bed.
2)
Compressed air pressure
3)
Rate of atomizing air pressure.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE 4)
Excaust System
5)
Spray pattern
TITLE: SOP FOR COATING PAN
Page : 02-02 Deptt.: PRODUCTION SOP No.: SPD/99 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. d)
After completion of coating, check laid down physical parameters of coated tablets as per the laid down procedure in the Product.
e)
Remove the coated tablets from the pan into double poly bags in aluminium containers properly labelled.
DISMANTLING:-
1)
2)
Switch off the mains of the following: a)
Hot air blowers
b)
Exhaust system
c)
Coating Pan
Remove:a)
Hot air blowers pipes
b)
Exhaust Pipes
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE TITLE: SOP FOR TRANSFER OF FINISHED GOODS TO Page : 01-02 FINISHED GOODS STORE Deptt.: PRODUCTION SOP No.: SPD/100 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Transfer of Finished Goods to Finished Goods Strore.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1 Finished formulations are kept in quarantine stores till it is cleared by Q.C.D. 5.2 Once cleared by Q.C.D. They are packed in strips/blister strip/bottles/jars etc. as per the individual case. 5.3 Once the product is packed they are transferred to commercial store vide the transfer note as per the following format:
FINISHED GOODS TRANSFER NOTE Product Name ____________________
Mfg. Date _____________
Batch No. ________________________
Exp. Date _____________
A.R. No. ________________________
M.R.P. Rs. ____________
Date of Release by Q.C. Deptt. ____________________________________________ Qty. transfer to warehouse ________________________________________________ Date of transfer of goods to warehouse ______________________________________ Packing Supervisor
Q.C. Deptt.
Q.A. Deptt.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE TITLE: SOP FOR TRANSFER OF FINISHED GOODS TO Page : 02-02 FINISHED GOODS STORE Deptt.: PRODUCTION SOP No.: SPD/100 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
5.4 Once the Product is transferred they are kept Product-wise with separate identity Slip/BIN Card attached. 5.5 Production dept. maintains a register indicating daily transfer details in the following format: Date
Product
Batch No.
Units Transferred
No. of cases
Sent by
Received by
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE TITLE: SOP FOR OPERATION & CLEANING OF TRAY Page : 01-03 DRIER Deptt.: PRODUCTION SOP No.: SPD/101 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Operation and Cleaning of Tray Drier.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
The entire Machine Operation is divided in three stages.
5.1
Pre-operative Cleaning & Setting.
5.2
Operation
5.3
Post Operative Cleaning and equipment preparation.
STAGE – I a) The electrical connections are restored by pulling the plug top into the socket. b) The exterior of the machine is cleaned with dry cloth. c) The “MACHINE READY FOR USE” Sticker is removed and sticker/tag showing product, Batch No. etc. is put on the top cover of the machine. d) Arrange a polythene bag kept in a plastic drum for storage of dried granules/material. STAGE – II a) The machine is switched on and run for few seconds to observe whether it is running normally or not. b) If any abnormal sound is heard the machine is referred to maintenance deptt. for rectification. c) Put the granule & powder in the trays & kept for drying.
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE TITLE: SOP FOR OPERATION & CLEANING OF TRAY Page : 02-03 DRIER Deptt.: PRODUCTION SOP No.: SPD/101 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
d) Then set the required temperature & drying time for 30 minutes & start the machine. e) After 30 minutes stop the machine & manipulate the material of trays. f) Again start the machine check the granules in between. g) Check the moisture content of granules if found under the limit, stop the drying. If not, continue the drying till the required moisture content is obtained collect the granules in a plastic bag in a fiber drum. h) The process is continued till the entire granules are dried. i) In case of batch change the contact parts are cleaned with dry clothes. j) Once the process is over put the sticker starting “to be cleaned” on the machine. k) In case of product or composition change the entire machine is washed and wash water analysis is to be done to by Q.C.D. render the machine is ready for further use. STAGE – III a) The connection is cut off by taking out the plug to from the socket. b) After the days operation a product change or change of composition the sticker starting “ to be cleaned” is removed. c) The trays are thoroughly washed with the help of detergent & wash with water till the to am is washed out then wash with D.M. Water. d) Once the wash water analysis is cleared by Q.C.D. set the machine. Below the F.B.D. A sticker starting “MACHINE READY FOR USE” in put on the machine to render it ready for use.
TITLE: SOP FOR OPERATION & CLEANING OF TRAY
Page : 03-03
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE DRIER Deptt.: PRODUCTION SOP No.: SPD/101 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
A logbook is kept for each machine of aeration in the following format: LOG BOOK OF MACHINE/EQUIPMENT Name of Machine/Equipments: TRAY DRIER
Page No.:………......……….
Machine/Equipment Code:
SOP No.: SPD/10
Location:……….......……….. Date
Start Time
Finish Time
Total Hours of Running
Break Down START END
Down Time Hours
TITLE: SOP FOR OPERATION & CLEANING OF ALU-ALU PACK MACHINE
Production/ Batch No.
Operated By
Checked By
Page : 01-03 Deptt.: PRODUCTION
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE SOP No.: SPD/102 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Oeration and Cleaning of ALU-ALU Pack Machine.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
OPERATION
5.1
Switch ‘ON’ the main supply of the machine
5.2
Switch ‘ON’ compressed air and chilled water to the machine.
5.3
Load the base material on to the base material reel feed shaft.
5.4
Maintain the distance of approx. 150 mm from the machine body surface to the center of the reel.
5.5
Load the lidding foil on the lidding foil red feed shaft.
5.6
Check the set the temperature of the pre-heater top heater top platen, bottom platen and sealing heater according to the base material and lidding material on the MMI.
5.7
Manually switch ‘OFF’ the pneumatically operated basic valve lever to pinch roller that is located on the indexing unit.
5.8
Then pass the base film to the indexing unit through pre – heater platen in between the top platen and bottom platen through dancing arm and guide rollers to the sealing station though the forming die and blow head of forming station pass over the web guide track.
5.9
On the MMI (Man – Machine Interface) recalled the program for particular formatting by switch ‘ON’ control panel and scrolling the MMI screen by entering the multiple level of password.
TITLE: SOP FOR OPERATION & CLEANING OF ALU-ALU PACK MACHINE
Page : 02-03 Deptt.: PRODUCTION
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE SOP No.: SPD/102 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
5.10
Enter all the information in the formatting part according to the product.
5.11
Switch ‘OFF’ the product feeding system.
5.12
Check all the safety guards are locked or closed.
5.13
Manually switch ‘ON’ the pneumatically operated basic value lever for engagement of pinch roller with indexing roller.
5.14
Then switch ‘ON’ the machine in ‘RUN MODE’ by pressing the ‘START’ push button.
5.15
The machine will form the blister in a continuous web from. Machine run for few cycles and then switches ‘OFF’ the machine.
5.16
Check the formed web for consisting of the form of blisters and the quality parameters of the formed web.
5.17
Drawn the Sealing / Lidding foil to the sealing station over the formed web passes through the batch code printing station.
5.18
Press the ‘START’ switch again for RUN the machine.
5.19
RUN the machine in the ‘RUN MODE’ for few cycles.
5.20
Then STOP the machine by pressing red push button and check the sealing performance.
5.21
Then pass the sealed web to the punching station where the quality blister pack punches out.
5.22
Again press ‘START’ push button.
5.23
RUN the machine in the ‘RUN MODE’ for few cycles. Then STOP the machine by pressing red push button and check for the blister pack correctness.
5.24
For any adjustment in sealing station for proper engagement of form blisters to the sealing die easily by moving the stations horizontally at LHS or RHS at required position.
TITLE: SOP FOR OPERATION & CLEANING OF ALU-ALU PACK MACHINE
Page : 03-03 Deptt.: PRODUCTION
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE SOP No.: SPD/102 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………...
6)
Sign.…….……….
5.25
For proper sealing of form blister web to the lidding foil by adjust the pressure adjustable screws.
5.26
For any adjustment in punching station moving the station horizontally at LHS or RHS can do according with blister pack that or RHS at require position.
5.27
Then waste web pass over the dancing arm trim winding assembly through the guide rollers where the waste firm wound over the trim winding shaft.
5.28
When the blister packs meet all the quality parameters then adjust the feeding system.
5.29
Above all the adjustments have been completed then gradually increase the machine speed recommended by the instruction manual.
5.30
Load the standard and specified input packing materials means base film and lidding foil with their specified dimensions and according with the product.
CLEANING PROCEDURE : 6.1
Cleaning the machine with mild hot distilled water.
6.2
Clean the hopper foil red feed shaft with distilled water.
6.3
Mope all the machine & machine parts with IPA.
6.4
Dry with open cloth.
6.5
Put the sticker ‘READ TO USE’.
TITLE: SOP FOR OPERATING OF AIR COMPRESSOR SOP No.: SPD/103 Effective Date: 15-07-2007
Revision No.:
Page : 01-01 Deptt.: PRODUCTION Review Date: 14-07-2009
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Prepared by: Asstt. Production Chemist
Checked By: Production Manager
Approved By Q.A. Manager Director
Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Operating of Air Compressor.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
5.1
Switch on the start switch of panel of air compressor.
5.2
Atmospheric air should come through free filter and is stored in receiver having a safety valve.
5.3
At the pressure of 7 kg or above the main machine releases out the excess air.
5.4
The air is passed through air drier. Firstly the air passed through carbon column and then silica column.
5.5
Then this air is passed through 0.2 micron in line air filter. Now this sterile air ready of use in production.
TITLE: SOP FOR OVER PRINTING ON STRIPS SOP No.: SPD/104 Effective Date: 15-07-2007 Revision No.: Prepared by: Checked By:
Page : 01-01 Deptt.: PRODUCTION Review Date: 14-07-2009 Approved By
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Asstt. Production Chemist
Production Manager
Q.A. Manager
Sign.…………………….… Sign.………………………. Sign.…………...
Director Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Over Printing on Strips.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
OPERATION
5.1
As the capsule or tablet passes in analysis the material shifted in stripping area.
5.2
For printing the sterio are prepared from approved vendor.
5.3
For sterio preparation the B. No., Mfg., Exp. & rates are taken from mfg. record.
5.4
As the sterio are received, all matter is checked in all respect.
5.5
The sterio are fixed on the machine.
5.6
Before starting the stripping the line clearance is checked & approval is taken from Q.A. person.
5.7
Final approval of matter coding on the strip is taken from Q.A. Person.
5.8
The approved foil is preserved in the record.
5.9
As the stripping starts random, sample is sent for Leak Test.
5.10
If the sample passes the stripping starts.
5.11
In process check is done after every 30 minutes of strips.
TITLE: SOP FOR LEAKAGE CHECK IN FILLED BOTTLE
Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/105 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Leakage Check in Filled Bottle.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
OPERATION
5.1
Draw the sample atleast 10 containers randomly.
5.2
Check whether the sealing is PERFECTLY done.
5.3
Keep all the bottle in inverted position.
5.4
After 24 hr. check the leakage in all bottle.
5.5
If there is any leakage it will be accumulated on the sealing side on the cap.
5.6
Maximum Tolerance limit is 0.1%.
TITLE: SOP FOR OVER PRINTING ON BOXES & LABELS
Page : 01-1 Deptt.: PRODUCTION SOP No.: SPD/106 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director
SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)
STANDARD OPERATING PROCEDURE Sign.…………………….… Sign.………………………. Sign.…………...
Sign.…….……….
1)
PURPOSE
:
To lay down a Procedure for Over Printing on Boxes and Labels.
2)
RESPONSIBILITY
:
Q/C Manager.
3)
ACCOUNTABILITY :
Production Manager/Q.A. Manager
4)
SCOPE
:
The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.
5)
PROCEDURE
:
OPERATION
5.1 Requisition is issued to the packing material store. 5.2 According the qty. mention in requisition, the boxes or labels are issued from packing material store to production department. 5.3 From production department the boxes or labels are sent to batch coding room. 5.4 First of all the line clearance is checked before starting the work. 5.5 Before batch coding the sorting of labels & boxes are done. 5.6 Percentage rejection is noted in B.P.R. 5.7 For overprinting the B. No., Mfg., Exp. & M.R.P. is given by production Incharge. 5.8 After printing of few boxes or labels, the matter is checked by Q.A. person. 5.9 If the everything is OK, the approved packing material is preserve in a register& overprinting starts.
REVISION STATUS: NEW
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