Document No. SMF/01/01
TITLE: Site Master File EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
PAGE No No. 1 of 35
SITE MASTER FILE OF
SOLITAIRE PHARMACIA PVT.LTD . PLOT NO.25 NO.25 Ext -1 -1 HPSIDC AREA BADDI DISTT SOLAN HIMACHAL PRADESH-173205
Dosage Dosage Forms Forms : Tablets Tablets (General (General & Hormonal Hormonal )
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TITLE: Index EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
Document No. SMF/01/01 Sr.No 1 2 3 4
Ti Title Cover Page Index General Detail
PAGE No No. 2 of 35 Page No. 01 02 03 04&05
Plant Location
5
General Information
06&07
6
Process Approach
08&09
7
Personal
10 To 12
8
Premises
13 To 15
9
Ventilation system & Utilities
16 To 19
10
Equipments
20 To 25
11
Sanitation & Documentation
26 & 27
12
Production
28 & 29
13
Quality Control
30 To 32
14
Dist Distri ribu buti tion on,, Com Compl plai aint nts s and and Prod Produc uctt Rec Recal alll
33
15
Self Inspection
34
16
Quality policy
35 REVISION INDEX
Sr. No.
Date
Document No.
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Document No. SMF/01/01
TITLE: General Detail EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
PAGE No No. 3 of 35
General Detail
3.1 3.1
Type Type of Indu Indust stri ries es
: Phar Pharma mace ceut utic ical alss Indu Indust stry ry..
3.2
Name of of Dosage Fo Forms
: Ge General Tablet, Ho Hormonal Ta Table blet
3.3
Works (Factory)
3.4
Marketing Office
:
Solitaire Pharmacia Pvt.Ltd Plot No. 25 Ext-1 HPSIDC Area, Baddi, Tehsil Nalagarh , Dist solan.(H.P) -173 205. Tel.: 09815777744 E-mail :
[email protected] :
[email protected]
: Solitaire Pharmacia Pvt.Ltd PLOT NO. 73,INDUSTRIAL AREA, PHASE II, CHANDIGARH.
Tel.: 0172-5000477,5000478 0172-5000477,5000478 Fax:5000477,2653293
3.5
Contact Persons
: Mr. Sanjeev Kumar Sethi (Managing Director)
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TITLE: Site Location Plan EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
Document No. SMF/01/01
PAGE No. 4 of 35 A M
Annexure:4.1
A R A V A T
Road No. 3
Plot no.19
SOLITAIRE PHARMACIA PVT. LTD. Plot no.25 Plot no26.
Plot no.
I
Plot no. R O A D
Plot no. Plot no.18
Road
Plot no 27 Plot no.28
Plot no.
Plot no.29
Plot no.
Road
Road
Spray Eng.
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Document No. SMF/01/01
PAGE No. 5 of 35
DRAW SCATCH OF PLANT LOCATION FROM RAILWAY STATION Amaravati Appt.
N.R.I Hospital
KALKA RAILWAY STATION
Solitaire Pharmacia Pvt. Ltd. Ltd.
NALAGARH
BADDI BUS STOP
BADDI
Annexure:4.2
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A L M I H S
PINJOR
H R A G I D N A H C
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Document No. SMF/01/01
TITLE: General Information EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
PAGE No No. 6 of 35
5.0 GENERAL INFORMATION
INTRODUCTION: SOLITAIRE PHARMACIA PVT LTD., a Baddi (H.P.) based company established by Mr.Sanjeev Kumar Sethi, who has deep knowledge and vast experience of pharmaceutical business .He has now ventured in setting up state of the art pharma manufacturing facility of WHO,cGMP standards. LOCATION :The plant is located at Baddi (Himachal Pradesh) in well connected industrial belt at a distance of 40 kms from Chandigarh Chandigarh on Pinjore Pinjore – Nalagarh Highway and is engaged in the manufacturing of solid dosage forms. The location is well connected with roads & railway station is i s about 20 kms at Kalka. Kalka. The plant is located on 997 square meter plot. The factory is constructed constructed and designed to meet the WHO, cGMP standards in consultation with highly qualified and experienced technical personnel’s approved by FDA for manufacturing and testing. The plant has AHU systems i.e., Air conditioning and Control humidity for all manufacturing departments to avoid cross contamination. Solitaire Pharmacia Pvt. Ltd has established a modern facility as per GMP standards to manufacture tablets (Non ß-Lactam) & Hormonal tablets . The unit is managed by experienced technical staff for production & quality control along with a team t eam of expert technicians. The company has a pharmaceutical formulation plant located on the Ground floor for hormonal product & first floor for Non ß-Lactam respectively
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SALIENT FEATURES
SOLITAIRE PHARMACIA PVT LTD. has observed and will practice the following:Factory designed and constructed as per GMP specification. Code of ethics in production and quality. Training to the personnel as per new guidelines. Electrification is done for easy energy audit. Illumination level 300 lux in all manufacturing areas. Water proofing of entire terrace slab. HPLC. UV-spectrophotometer under one roof.
Pre-Construction Anti-Termite Pest Control treatment for entire factory building The company has full fledged Quality Assurance, Purchase, Store, Production, Administration Engineering Dept., headed by very experienced personnel’s.
All standard operating procedure (work instruction) related with above production process are available with QA department & individual department. Facilities & list of equipment are available in site master file. List of Proposed products and and other technical technical details are are available in site master file. Plant is fully equipped with: 5.1 Exhaustive pest control system to ensure total total freedom from insects and rodents. rodents. 5.2 Wall, floor and ceiling painted, free from crack, dust and dirt. 5.3 Full Fledged water system system i.e.(a) Raw water system equipped with sand filter to ensure free from Insoluble and gaseous gaseous impurities (b) R.O water plant for for Purified Purified water Core team of HOD’s of Quality assurance/Quality Control, Engineering, Production & Adm. Working under Managing Director ensures effective quality system, planning and Implementation.
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TITLE: Process Approach EFFECTIVE DATE NEXT REVIEW DA DATE 01.10.2009 30.09.2010
PAGE No. 8 of 35
TYPE OF PRODUCTS LICENSED FOR MANUFACTURE WITH FLOWCHART MENTIONING PROCEDURE PROCEDURE AND PROCESS FLOW : (i) Soltaire Pharmacia Pvt.Ltd manufactures manufactures wide range of pharmaceuticals formulations in General Categories of General Tablet & Hormonal tablets as per the approved Product List enclosed (ii) For pr process flflow & procedure flflow ch chart as as pe per fo following.
Tablets Sieving
Weighting
Visual Inspection
Q.A.-2
Wet or dry Granulation
Mixing
Compression
Q.A-1
Lubrication
Drying
Sizing / Milling
Q.A. Q.A. - 4
Coating
Tablet packing
Q.A.-3
Visual Inspection
Final Release
Q.A. Q.A.-- 4
Tablet packing Q.A. Q.A.-- 5
Final Release
Sampling QA1 QA2 QA2
----------
QA3 QA4 QA5
-------
Testing Water content, Bulk density Weig We ight ht vari variat atio ion, n, Appe Appear aran ance ce,, Colo Colour ur Shape, D.T, Hardness, Friability D.T. Appearance D.T, Appearance, Pathogen and In process labeling, packing details
Dispatch
Annexure:6.1
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TITLE: Process Approach EFFECTIVE DATE NEXT REVIEW DA DATE 01.10.2009 30.09.2010
PAGE No. 9 of 35
Solitaire Pharmacia Pvt.Ltd has facility to carry out Chemical Physico-chemical, Instrumental Analysis
Solitaire Pharmacia Pvt.Ltd takes assistance from outside institution for testing its samples Samples are sent for getting testing done where sophisticated instruments like IR, GC & BioAssay are required. . there will be basically four type of process in the organization a. Core process (customer related process) b. Management process (process carried out by top management /MR) c. Supporting process (process to help core /management process) d. Work process (process flow as per individual department wise Customer PROCESS APPROACH:
Dispatch
Satisfaction Quality Policy & Quality Objective (Business Plan)
Production Marketing
Budgeting (Resource Plan)
Management Process
Core Process
Management Review / Audit Customer Order
Resource Allotment
Production / Service Planning
Material / Production / Service / testing
Material service procurement / storage
Annexure:6.1
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Document No. SMF/01/01 7.0
TITLE: Personnel EFFECTIVE DATE NEXT REVIEW DA DATE 01.10.2009 30.09.2010
PAGE No. 10 of 35
PERSONNEL
(a) ORGANISATIONAL CHART SHOWING THE ARRANGEMENTS FOR QUALITY ASSURANCE INCLUDING PRODUCTION & QUALITY CONTROL
:
HIERACHICAL CHART
Managing Director
Plant Head
Q.C In Charge
Q.A In Charge / Management Re re rese sent ntat ativ ivee
Engineering In Charge
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Store In Charge
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TITLE: Personnel EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
PAGE No No. 11 of 35
(b) QUALIFICATION, EXPERIENCE EXPERIENCE & RESPONSIBILITIES OF KEY PERSONNEL :
Sr. No. (A) (A) 1 2 (B) (B) 3
Name of Person
Qualification
MANU MANUFA FACT CTUR URIN ING G SECT SECTIO ION N Mr. Rajesh B.Pharm Makanwal Mr Ram lal B.Sc. Prajapati QUAL QUALIT ITY Y CON CONTR TROL OL SECT SECTIO ION N Mrs. Jahanvi Rao M.Sc.
Experience
Department
Approval / Unapproved
8 yrs
Mfg. Section
Approved
18 yrs
Mfg. Section
Approved
16 yrs
Chemical and Physicochemical Section
Approved
Number of employees to be engaged in production, quality control, storage and distribution. Production Dept. : 10 Quality control & Assurance Dept. : 06 Store ( RM, PM & FG) : 04 P & A Dept. : 03 Maintenance Dept. : 03 Account Dept. : 02 Total : 28
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PAGE No No. 12 of 35
(c) OUTLINE FOR ARRANGEMENT FOR BASIC AND IN SERVICE TRAINING AND HOW RECORDS ARE MAINTAINED : All employees employees will have to go through training as per annual training plan. Training on GMP will be on-going process process and all the employees employees will be regularly trained trained to increase their awareness awareness of current requirements. Immediate outside experts & superior impart through training for all departmental. departmental. The employees are subjected to oral & written quarries. The training records will be maintained for all employees. (d) HEALTH REQUIREMENT FOR PERSONNEL ENGAGED IN PRODUCTION : Administrative head is responsible for arranging the medical checking of employees through a qualified physician. Medical examination is carried out by company approved physician every year or in between if required. For any unusual findings during the check up physician advises the person affected. During the treatment period suitable reallocation of job is done. Rechecking is done following approved guidance & frequently, and after the person is certified medically fit, he is put on his original job. (e) PERSONNEL HYGINE REQUIRMENTS, INCLUDING CLOTHING : The company provides change rooms for changing company uniforms including shoes. The employees working in production area change their shoes and wear factory footwear, along with factory uniforms & cap. The employees in other areas like Quality control will wear aprons and laboratory slippers. The employees in engineering department wear suitable shoes and factory uniforms. All the employees have been instructed about dress code and to change the dress every other day. Other aspects of personnel’s hygiene like daily bath, hair & nail cut.
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Document No. SMF/01/01 8.0
TITLE: Premises EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
PAGE No No. 13 of 35
PREMISES
(a) LAYOUT PLAN OR DESCRIPTION DESCRIPTION OF MANUFACUTRING MANUFACUTRING AREA : Sr. No. 1. 2. 3 4 3. 4.
Sr. No. 1. 2. 3. 4. 5. 6 7 8 9 10 11
Area Ground floor First floor Second floor Service Area Utility Block D.G.Set Area
Ground floor Area MD & Adm. Office Warehouse Change room Toilet R.M.Store HormonalProduction Security office Visitors Rooms Hormonal Packing Utility Bl Block D.G & Pannel Area
Type of area finishing RCC Roof, Kota St Stone & Flush do doors. RCC Roof, Kota Stone & Flush doors. Vetrified tiles in Q.C Area RCC roofs & Covered with fancy hood RCC Floor RCC Floor
Sr. No. 1. 2. 3. 4.
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First floor Area GeneralProduction General Packing Approved R.M Store Approved P.M Store
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Sr. No. 1. 2. 3. 4. 5. 6. 7. 8. 9.
Second floor Area Incubator Chemical section Retain sample Record room Stability chamber Q.C.Office Micro testing Media prepn Room Instrument Room
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TITLE: Premises EFFECTIVE DATE NEXT REVIEW DATE
PAGE No No.
SMF/01/01 01.10.2009 30.09.2010 14 of 35 Canteen & toilet is not directly attached with production area. Plant layout design & equipment is as per the t he revised schedule-M requirement. (b) NATURE OF CONSTRUCTION & FIXTURES / FITTINGS FITTINGS : Building: The building is made up of RCC construction and all the processing areas from inside are having smooth wall painted with oil paint/oil bound emulsion paint. Utility: Manufacturing equipments are provided power supply back up with DG set, which is bale to restore DG power within 2 minutes. The critical QC instruments are also provided with stabilizer. Aluminum doors & Windows: The doors and windows are designed very carefully to have a minimum number of horizontal surfaces. The sills of the windows are sloping. The windows are kept flush with the plaster inside manufacturing areas and gap between aluminum and masonry are sealed with scaling. Floor: Flooring is made up of mirror polished Kota stone. Coving: Coving is provided in all production areas at the junction junction of wall to floor, wall to wall to ceiling and are painted with washable paint. Fall ceiling: Fall ceiling in the air-conditioned areas is of plaster of paris sheets. The sheets is fixed with double double layered arrangement arrangement and the joints of the upper layer layer and lower layer of the board are so arranged (staggered) that there is no leakages of air. All entrances and major doors are provided with air lock and air curtains wherever required. The sanitary fittings are connected and drainage system is under ground and provided with trapped gullies. S.S Light S.S-304 riser Both Side Stair & Well Equipped Lift provision
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TITLE: Premises EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009
30.09.2010
PAGE No No. 15 of 35
(d) SPECIFIAL AREAS FOR THE HANDLING OF HIGHLY TOXIC, HAZARDOUS & SENSITIZING MATERIALS: Not Applicable, as presently we do not use s uch type of materials. (e) BRIEF DESCRIPTION OF WATER SYSTEMS (schematic drawings of systems) : Copy attached Total 4 sampling points are provided for water system monitoring, cleaning, cleaning, sanitation and validation plan is followed followed as per standard operating procedures, procedures, water log book & water validation file. (f) DESCRIPTION OF PLANNED PREVENTIVE MAINTAINANCE PROGRAMMES FOR PREMISES AND OF THE RECORDING SYSTEM : More emphasis is given on the preventive maintenance program of plant utility services, machines etc. Maintenance department is equipped with highly qualified and experienced engineers and technicians. Maintenance as well as plant operators are provided through training at machine manufacturing manufacturing site for knowing its operation, use, accuracy, efficacy etc. Installation qualification qualification & performance qualification qualification of every new machine is carried out. Calibrations Calibrations are done frequently. The logbooks are maintained for all critical equipments. Whenever necessary, necessary, help of outside maintenance consultants is taken to maintain facilities such as Air handling units, laminar air flow, pest control etc. routines as well as periodical maintenance maintenance are scheduled and documented. For recording system computer validation system is f ollowed. ollowed.
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Document No. SMF/01/01
TITLE:VENTILATION SYSTEM & UTILITIES EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
SR. NO.
1
PAGE No No. 16 of 35
DESCRIPTION
AIR HANDLING UNITS HOREMON-Ground HOREMON-Gr ound Floor AHU-1-4000CFM-65mmAHU-1-4000CFM-65mm- 8TR[Grenulation] 8TR[Grenulation] AHU-2-600CFM-65mmAHU-2-600CFM-65mm- 1.5 TR[Sampling/Dispensin TR[Sampling/Dispensing] g] AHU-3-600CFM-65mmAHU-3-600CFM-65mm- 1.5 TR[TIB] AHU-4-1200CFM-65mm-3TR[Blister Pack] AHU-5-800CFM-65mm-2TR[Strip Pack] AHU-6-800CFM-65mm-2TR[Compression] AHU-7-1200CFM-65mmAHU-7-1200CFM-65mm- 3TR[Coating] 3TR[Coating] AHU-8-3200CFM-65mmAHU-8-3200CFM-65mm- 6TR[Corridor 6TR[Corridor & Misc.] Misc.] AHU-9-600CFM-65mm-1.5TR[Sampling] AHU-10-800CFM-65mmAHU-10-800CFM-65mm- 2TR[Blending] 2TR[Blending] AHU-11-600CFM-65mmAHU-11-600CFM-65mm- 1.5TR[Sampling] 1.5TR[Sampling]
General Tablets-First Floor AHU-12-4800CFM-65mm-10TR[Granulation] AHU-13-1200CFM-65mm-3TR[Blending] AHU-14-1200CFM-65m AHU-14-1200CFM-65mmm- 3TR[Coating-1] 3TR[Coating-1] AHU-15-1200CFM-65m AHU-15-1200CFM-65mmm- 3TR[Compression-1] 3TR[Compression-1]
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AHU-16-800CFM-65mmAHU-16-800CFM-65mm- 2TR[Compression-2] 2TR[Compression-2] AHU-17-600CFM-65mmAHU-17-600CFM-65mm- 1.5TR [TIB] AHU-18-600CFM-65mmAHU-18-600CFM-65mm- 1.5TR[Dispensing] 1.5TR[Dispensing] AHU-19-1200CFM-65mm-3TR[Blister-1] AHU-20-1200CFM-65mm-3TR[Blister-2] AHU-21-800CFM-65mmAHU-21-800CFM-65mm- 2TR[Strip Packing] Packing] AHU-22-3200CFM-65m AHU-22-3200CFM-65mm-6TR[Corrid m-6TR[Corridor or & Misc.] AHU-23-1200CFM-65m AHU-23-1200CFM-65mmm- 3TR[Coating-2] 3TR[Coating-2]
Quality Control-Second Floor AHU-24-600CFM-65mmAHU-24-600CFM-65mm-1.5TR[ 1.5TR[ Micro Q.C.]
2
Forcd Draft Ventillation Supply Air System[GROUND FLOOR] FDVS-1:2000-20[Gen.Ch.Room] FDVS-2:1000-50[Hormon Ch.Room] FDVS-3:1000-20[Hormon PMS] FDVS-4:1000-20[General PMS] FDVS-5:3000-20[Misc. FDVS-5:3000-20[Misc. Q.C.Area]
3
Forcd Draft Ventillation Exhaust Air System[GROUND FLOOR] FDVE-1:1000-20[Gen.Ch.R FDVE-1:1000-20[Gen.Ch.Room-First oom-First floor] [Not Require as Room Exhaust-Hormon] FDVE-3:1000-20[Hormon PMS] FDVE-4:1000-20[General PMS] [Not Require as Room Exhaust-Q.C]
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4
Refrigeration Type Dehumidifire 1 TR 2 TR
OTHER OTHE R UTILI UTILITIES[ TIES[GROU GROUND ND FLOOR FLOOR]]
5
Air Compressor-1 Air Compressor-2
6
Compressed Air Dryer
7
D.M W ater Plant
8
D.M W ater Plant
9
ETP
Split A.C Misc. Stores[GROUND FLOOR] R.M.Approved Store Horemone F.P.S Secondary Packing Hall General FP Stores Director's Office Reception
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Manager Office Staff Office
Split
RM Stores[FIRST FLOOR]
A.C
Approved RM[14a] ALU.PVC Store[14b]
Split A.C Misc. Areas[SECOND FLOOR] Q.C.Manager Critical Instrument Room General Instrument Room Retain Sample Room
Minimum 20 air changes are provided in all production area, supply filter are having 5 porosity & return filter are having 20 porosity. Minimum 0.5mm pressure difference is kept in different categories of production area with maximum positive pressure kept in filling & sealing area. Refer plan layout Annexure 1 for more details.
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Document No. SMF/01/01 4.0
TITLE: Equipment EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
PAGE No No. 20 of 35
EQUIPMENT (a) BRIEF DESCRIPTION OF MAJOR EQIPMENT USED IN PRODUCTION & CONTROL LABORATORIES :
General Tablets NAME OF MACHINE
SUPPLIER
CAPACITY
ELE. LOAD H.P
FLUID BED DRIER VIBRO SIFTER R.M.G PASTE KETTLE MULTIMILL LUBRICATION OCTAGONAL BLENDER COATING-1 COATING PAN SOLUTION PREPARATION TANK COLLOID MILL COATING-2 COATING PAN COMPRESSION ACRA- B4-27-D
TECHX
QTY(CFM)
PRESSURE(K G)
60 KG
14.0
100
6.0 kg
TECHX TECHX TECHX TECHX
36” 150 LTR 100 LTR 250 KG/HR
1.0 28.0 5.0 3.0
10
6.0 kg
TECHX
300 LTR
3.0
TECHX TECHX
36” 50 LTR
7.0 0.7
TECHX
36”
7.0
FLUIDPACK
5 .0
ACRA-B4-27- D
FLUIDPACK
DUST EXTRACTOR-1
FLUIDPACK
27 STN (D – TOOLING) 27 STN (D – TOOLING) 150 CFM
TECHX
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AIR
3.0
5 .0 1.50
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150
Managing Director Approved by
DUST EXTRACTOT-2 DEBURRING&DED USTING UNIT 4 NO. PACKING BLISTER ALU-ALU CONVEYOR BELT-1 CONVEYOR BELT-2
FLUIDPACK
150 CFM
1.50
F.P MACHINERIES
150
2.0
KULBINDRA P.G
9.0 9.0 1.0
150 150
6.0 kg 5.0 kg
150
4.0 kg
1.0
HORMONAL SECTION GRANULATION SECTION FLUID BED TECHX DRIER VIBRO SIFTER TECHX R.M.G TECHX MULTIMILL TECHX LUBRICATION OCTAGONAL TECHX BLENDER COATING-1 COATING PAN TECHX SOLUTION TECHX PREPARATION TANK COMPRESSION ACRA- B4-27-D FLUIDPACK
DEBURRING&DED USTING UNIT 4 NO. DUST EXTRACTOR-1 PACKING BLISTER STRIP CONVEYOR BELT-1 CONVEYOR BELT-2 D.G. SET
10 KG
8.0
12” 25 LTR
0.5 5.0 2.0
50 LTR
1.5
24” 50 LTR
5.0 0.7
27 STN (D – TOOLING
5.0
F.P MACHINERIES
FLUIDPACK
1.0
150 CFM
KULBINDRA KULBINDRA
8.80 3.5 1.0 1.0
SUDHIR GENSET
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200 KVA
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AIR COMPRESSOR AIR DRIER R.O.PLANT
KAILA ENGIN
E.T.P PLANT
MAINSA E NGG. WORKS
A.H.U
DYNAFLOW
KAILA ENGIN ARYATEC H
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10.0
1000 LTR/HR 3000-5000 LTR
2.0 7.0 7.0
250.0
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Document No. SMF/01/01 SR.NO. 1 2 3 4 5 6 7 8 9 10
TITLE: Equipment EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010 NAME
HPLC UV spec spectr trop opho hoto tome mete ter r Anal Analy ytic tical Bal Balan anc ce pH meter Abbe Abbe refr refrac acto tome mete ter r Polarimeter KF apparatus UV ca cabinet Melti Melting ng point point appar apparatu atus( s(di digit gital) al) Potent Potentiom iomet eter/ er/Au Autot totit itrat rator or
MAKE Waters Shimadzu
MODEL NO, 515 UV-1800
PAGE No No. 23 of 35
SPECIFIC ATION Isocratic system Std.
CHEMICAL CHEMICAL SECTION SR.NO. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
NAME OF LABORATORY INSTR. Vaccum ov oven Sonicator Mech Mechan anic ical al flak flak shak shaker er W ater bath Univ niversal ov oven Muffl ffle furnac nace Heat eating ing mant antle Hot Hot pla plate te with with stir stirre rer r Dist. Water app. (wall mounted)s.s TLC kit Bulk Bulk dens densit ity y appa.( appa.(Ta Tappi pping ng type) type) Disso Dissolut lution ion test test appa appa.. 8 bas baske kets ts Leak Leak tes test ap appa. Friability appa.(digital rpm counter) Hard Hardne ness ss test tester er IR moist oistur ure e bal balan ance ce Cent Centri rifu fuge ge mac machi hine ne Vortex mi mixer
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MAKE
MODEL NO,
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SPECIFIC ATION
Managing Director Approved by
SR.NO. 1 2 3 4 5 6
NAME OF LABORATORY INSTR. Microscope Autoclave Bacter Bacteriol iologi ogica call incu incubat bator or BOD in incubator Colo Colony ny cou count nter er(d (dig igit ital al)) Laminar Air Flow bench
MAKE
MODEL NO,
Popular
SPECIFIC ATION
Horizontal
(b) DESCRIPTION OF PLANNED PREVENTIVE MAINTAINANCE PROGRAMS FOR EQUIPMENT & OF THE RECORDING SYSTEM : As mentioned in point planned preventive maintenance exists and the records are maintained for preventive maintenance and major breakdown of equipment and machine. (c) QUALIFICATION & CALIBRATION INCLUDING THE RECORDING SYSTEM AND ARRANGEMENT ARRANGEMENT FOR COMPUTERIZED SYSTEMS VALIDATION : Periodic calibration calibration / validation of equipments / process / Utilities / system / personnel are carried out and records are maintained. For certain equipments and utilities validation is carried out periodically by the standard external agencies. Calibration / validation schedule protocol is as per calibration / validation Index . It is audited in self-inspection. Written standard operating procedures are laid for cleaning of manufacturing areas and equipments. equipments. For area cleaning two type disinfectants are used fortnightly alternatively. Review of standard operating procedure procedure is made at every three years and any correction / deviation is properly recorded after getting authorization authorization from Q.A. as per procedure of document & data control. Pest control of the entire plant is maintained through administration department with the help of outside agencies.
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Document No. SMF/01/01
TITLE: Equipment EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
PAGE No No. 25 of 35
List of Calibration of Equipments / Instruments Sr.No. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22
Item Pest Control Medical Checkup of of Employee Aseptic Filling (Media Fill test) Filter Integrity Testing Manufacturing tank pH Meter Single Pan Balance Plate form Balance Spectrophotometer Auto clave Dry heat sterilizer Aseptic Area U.V. Light Thermometer Glass equipment Normality Testing Pressure/Temp.gauges/Hygrometer Hepa filters Product Stability studies Inter Department Audit Melti eltin ng point int App Apparat aratu us Karl Fischer apparatus
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Frequency of Calibration/ Validation Yearly Yearly Yearly Batch wise At the time of purchase Daily Daily/ Yearly Daily/ Yearly Monthly Daily/Quarterly Daily/Quarterly Daily Quarterly At the time of use At the time of purchase At the time of use Yearly Yearly As per individual product Quarterly Month onthly ly At the time of use
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Document No. SMF/01/01 11.0
TITLE: Sanitation / Documentation EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
PAGE No No. 26 of 35
SANITATION
(a) AVAILABILITY OF WRITTEN SPECIFICATION & PROCEDURE FOR CLEANING MANUFACTURING AREA & EQUIPMENT :
Sanitation of entire plant, surrounding and manufacturing area is being done as per area cleaning SOP’s Efficacy of Disinfectant solutions is validated microbiologically. HVAC system & water system is also continuously sanitized and the same is recorded in utility logbook. Validation of the equipment equipment cleaning will be done as per master validation plan.
11.A 11.A DOCU DOCUME MENT NTAT ATIO ION N (a)
ARRANGEMENT ARRANGEMENT FOR THE PREPARATION, REVISION & DISTRIBUTION OF NECESSARY DOCUMENTATION FOR MANUFACTURE:
a. b. c. d. e. f.
WellWell-de defin fined ed system system exists exists for in wardi warding, ng, storag storage e and issue issue of raw & packin packing g materials. Raw Raw & pack packin ing g mate materia rials ls are sampl sampled ed and approv approved ed by Qualit Quality y Cont Control rol depart departme ment. nt. Batch Batch manufa manufactu cturin ring g reco records rds (BMR) (BMR) for every every produ product ct and and every every batc batch h is is issue issued d by by quality assurance to production department. In proces process s check checks s at at regul regular ar interv intervals als are carrie carried d out out with with prop proper er docum document entati ation on by Q.A. Q.A. All manufa manufactu cturin ring g opera operatio tion n is follow followed ed as per per ins instru tructi ctions ons given given in in BMR BMR and and entai entaill heads before submission to Q.A. for final f inal approval of the batch. Before Before final final dispa dispatch tch of every every batch batch,, Quali Quality ty assuran assurance ce depar departme tment nt verifi verifies es BMR along along with certificate of analysis and release slip is issued. Solitaire Solitaire Pharmacia Pvt. Ltd. maintains maintains documents regarding: regarding: Standard Operating Procedure & its related records. Site Master file Specification of all Materials & Finish products Test procedure & protocol Master formula card Batch production & control records Disposal records Release records & distribution records Calibration / Validation records Quality management system related documents
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Document No. SMF/01/01
TITLE: SANITATION & Documentation EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
PAGE No No. 27 of 35
Standard operating procedure are prepared for each and every operation and are authorized for all the departmental activities activities and strictly followed. All minor changes in the documents are recorded in the same records by recalling copies from all departments for authorization by QA head with date of correction. For major changes entire documents are replaced with amendment amendment copy and old copies are destroyed except one kept with QA department with cancellation. A detail of documents withdrawal withdrawal / distribution will will be kept with QA department department under document and data control index. Necessary document document related to manufacturing manufacturing such as Master formula formula card and Batch manufacturing & its associated record are maintained and issued by Q.A.department. Q.A.department. (b) ANY COPY OTHER DOCUMENTS RELATED TO PRODUCT QUALITY THAT IS NOT MENTIONED ELSEWHERE : (E.G. MICROBIOLOGICAL CONTROLS IN AIR & WATER) Following methods are followed as per well-defined schedule:
Microbial counts and limit tests for bore well, DM water and finished products. Manufacturing, Manufacturing, filing & sealing areas environmental monitoring monitoring by setting plat count.
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Document No. SMF/01/01
TITLE: Production EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
PAGE No No. 28 of 35
7.0 PRODUCTION (a) BRIEF DESCRIPTION OF PRODUCTION OPERATIONS : Production operation is explained by way of flow chart describing movement of material & movement of batch manufacturing record. Refer Annexure Refer Annexure 6.1 attached. (b) ARRANGEMENTS ARRANGEMENTS FOR THE HANDLING OF STARTING OF STARTING MATERIALS, PACKAGING MATERIALS MATERIALS & BULK & FINISHED PRODUCTS INCLUDING SAMPLING, QUARANTINE, RELEASE & STORAGE : Each consignment of material received is examined visually and damaged goods are kept separate and inform to quality control person f or further instructions for disposal or return goods to party. On verification of quantity received and making batch wise segregation identification number is given serially. All the containers are labeled “UNDER TEST” with details such as name, inward number, quantity, no. of containers, manufacture’s name, material code no. and put material in to the quarantine area. Samples are drawn as per sampling plan & tested in detail as per specification by quality control. On completion of tests Q.C. decided whether the material is approved or rejected and accordingly if material is approved, “APPROVED” label are fixed and material is transferred to approve material storage area. If material rejected than transfer to rejected area (Flow chart of Movement of material is enclosed). All packing materials are stored securely under lock & key and issued in requisite number only. At various places of operation separate areas are created so that the material or product is held on “Under Test”, “Approved”, “Rejected” or “Quarantine” area etc. All raw materials are t ransported in closed labeled containers or properly labeled sealed plastic bags. The Quality Assurance instructions are followed for material status. All weighing balance are regularly calibrated.
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Document No. SMF/01/01
TITLE: Production EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
PAGE No No. 29 of 35
(c) ARRANGEMENTS FOR THE HANDLING OF REJECTED MATERIALS & PRODUCTS : For all rejected materials, the materials are separated from other “Approved” or “Under Test” lots and “Rejected” labels are affixed by the Quality control persons. The rejected material is transferred to a separate “Rejected materials” area. Quality assurance decides the fate of such rejected materials as to destroy, reprocess or to refer to the supplier. (d) BRIEF DESCRIPTION OF GENERAL POLICY FOR PROCESS VALIDATION : Process validation is as per documented program (master validation plan), which provides a high degree of assurance assurance that a specific process process will consistently consistently produce produce a product meeting meeting it’s predetermined predetermined specification and quality attributes. We follow the following systems with regard to process validation:
Establish specification and performance criteria. Select methodology, process & equipment to ensure the product meets with the specification. Test the final product using validated analytical methods in order to meet specification.
Following steps supports the above steps:
Calibration, Calibration, verification and maintenance of process equipments. Qualification of both process & equipment. Challenge, Challenge, audit, monitor or sample the recognized critical or key steps in the process. And finally when there is a significant change in the product or process, Re-qualify or revalidate the process.
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Document No. SMF/01/01
TITLE: Quality Control EFFECTIVE DATE NEXT REVIEW DA DATE 01.10.2009 30.09.2010
PAGE No. 30 of 35
SHORT DESCRIPTION OF THE QUALITY MANAGEMENT SYSTEM OF THE FIRM
The company believes in total quality management system and constantly upgrading standards of specification specification of its products & services. The quality policy states as under,
We at Solitaire Pharmacia Pvt Ltd are Committed,
To supply Quality medicines at competitive rates & Service to Satisfy our Customer.
To follow prevailing National & International Standards of Pharmaceutical Industry.
To continually improve our Quality our Quality Management System with Continual Training & Collective Wisdom.
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Document No. SMF/01/01
TITLE: Quality Control EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
PAGE No No. 31 of 35
Quality has been the most prime consideration consideration in recruitment of manpower. Our organization chart explains the hierarchical levels of the organization. organization. For strengthening the system, following activities are carried out by Pharma consultants. The in-house training programme covers all relevant aspects of cGMP. Testing as per well defined specification control the input materials and release procedures for semi finished and finished products exit. Production as well as Quality assurance monitors quality quality by carrying out in process testing during various stages of manufacturing. Standard operating procedures are available for different operations. Products are manufactured as per procedure given in batch manufacturing records and recorded accordingly. Standard validation/calibration validation/calibration protocols adhered for validation of all critical equipments processes/instruments/pro processes/instruments/products/system/util ducts/system/utilities ities etc. Master formula records, which are prepared for individual products, are adhered in batch manufacturing & testing processes. Maintenance Maintenance history records are maintained for critical instruments and equipments to ensure proper preventive maintenance. The assessment of effectiveness of QMS is done by periodic self-inspection & management review meeting. a. Incom Incoming ing materi material al Quali Quality ty b. Prod Produc uctt Qual Qualit ity y c. Complian Compliance ce with with system systems s / docume document nt control control d. Custom Customer er compl complai aints nts e. Correctiv Corrective e action action to to avoid avoid non-co non-conform nformity ity f. Inte Intern rnal al Qual Qualit ity y Aud Audit its s
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Document No. SMF/01/01
TITLE: Quality Control EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
PAGE No No. 32 of 35
QUALITY CONTROL (a) DESCRIPTION OF QUALITY CONTROL SYSTEM AND OF THE ACTIVITES OF THE QUALITY CONTROL / QUALITY ASSURANCE DEPARTMENT PROCEDURE FOR THE RELEASE OF THE FINISHED PRODUCTS : Quality assurance & Quality control department combines activities performed are as follows. Specification of raw material, Packing material & Finished products are prepared, standardized & pharmacopoeia guidelines are followed for the same. Outside help is procured for developing in-house specification in area where pharmacopiea specifications specifications do not exist. Methods for reagent standardization and instrument calibration / validation are defined and being followed. Procedure for the release of raw material and finished products are defined and being followed as per the standard procedure and the norms down in pharmacopiea or by developing in-house specification. Company is having well-equipped Quality control laboratory having Physico-chemical instrumentation instrumentation and microbial testing. Laboratory facilities with necessary retain sample and documentation storage area. All well define procedures for finished product analysis are followed and finished product release for the market after complete testing. The store dispenses the materials in presence of Q.A. person against bill of materials issued. The dispensed materials carry appropriate labeling. Manufacturing Manufacturing activities are started as per Batch manufacturing record. In-process checks are carried out by production and Q.A. independently. independently. Coded packing materials are checked by production and Q.A. for the correctness of batch coding details. The packing department reconciles the printed packing materials. Batch production records are reviewed by production and Q.A. and yield data are reconciled by production and Q.A. Q.A.department Q.A.department also approves transfer transfer of finished product to finished finished product store for sale. Q.A. maintains control samples of raw material and finished products. Stability studies are carried out by Q.A. SOP compliance and GMP implementation is monitored by Q.A.
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TITLE: Distribution, Complaints & Product recall Document No. EFFECTIVE DATE NEXT REVIEW DATE SMF/01/01 01.10.2009 30.09.2010 10.0
PAGE No No. 33 of 35
DISTRIBUTION, DISTRIBUTI ON, COMPLAINTS & PRODUCT RECALL
(a) ARRANGEMENTS AND RECORDING SYSTEM FOR DISTRIBUTION : Finished goods will be transferred from packing department department to finished finished goods stores stores with transfer note, after getting final release for sale from Q.A. department. For each batch of the final product distribution records are available with dispatch department inside the factory premises (b) ARRANGMENTS FOR THE HANDLING OF COMPLAINTS AND PRODUCT RECALLS : On receipt of quality complaints from the customer, Informed to Q.A. department for the same Q.A. department will recheck retain samples and records for the same. Q.A. will send investigation report to customer through M.D. In case of critical complaints decision for recalling the product will be taken by top management and is communicated to distribution manger. Distribution manager will recall the products as per product recall SOP. Suggestion / complain register for all complaints / suggestions of external / internal origin will be maintained & same is reviewed in management review meeting.
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Document No. SMF/01/01 11.0
TITLE: Self Inspection EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
PAGE No No. 34 of 35
SELF INSPECTION
(a) SHORT DESCRIPTION OF SELF-INSPECTION SYSTEM : The self inspection system is based on the Standard Operating Procedure on cGMP requirements covering the following items. a. b. c. d. e. f. g. h. i. j. k. l. m. n. o.
Personnel Prem Premis ises es incl includ udin ing g pers person onne nell faci facili liti ties es Mainte inten nance nce of bui buildin lding g & equi quipme pments nts Stor Storag age e of of sta start rtin ing g mat mater eria ials ls 7 fin finis ishe hed d pro produ duct ct Equipments Production & In-pr -process controls Quality control Documentation Sanitation & hygiene Validation & revalidation program Cali Calibr brat atio ion n of ins instr trum umen ents ts or or meas measur urem emen entt syst system ems. s. Recall procedures. Complaint management Labels control Resu Result lts s of of pre previ viou ous s selfself-in insp spec ecti tion on & cor corre rect ctiv ive e ste steps ps tak taken en
QA head will appoints a self-inspection team from local staff, who are expert in their own field and with cGMP & if required,outside expert will be retained by us. This self-inspection will be done once in six month with the help of outside expert. A report will be made after compliance of the self-inspection, self-inspection, which includes, 1. 2. 3.
Self-inspection results Correction & root ca cause an analysis Recommended cor corrective ac actions.
The company management evaluates both the self-inspection report and the corrective action as necessary.
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Document No. SMF/01/01
TITLE: Self Inspection EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010
PAGE No No. 35 of 35
QUALITY POLICY SOLITAIRE PHARMACIA PHARMACIA PVT LTD IS COMMITTED COMMITTED TO ACHIEVE QUALITY STANDARDS USING NATIONAL & INTERNATIONAL NORMS WITH CONTINUOUS IMPROVEMENT IN PRODUCTS AND SERVICES FOR ULTIMATE SATISFACTION OF ALL OUR VALUED CUSTOMERS.
SOLITAIRE PHARMACIA PHARMACIA PVT LTD LTD IS “DEDICATED TO LIFE” AND QUALITY IS A WAY OF LIFE AT SOLITAIRE PHARMACIA PVT LTD
MANAGING DIRECTOR
( Sanjeev Kumar Sethi )
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