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INDEX
SL. No.
TITLE
PAGE NO.
1.
INDEX
1
2.
APPROVAL SHEET
2
C.1
GENERAL INFORMATION
3 TO 15
C.2
PERSONNEL
15 TO 18
C.3
PREMISES AND EQUIPMENT
18 TO 34
C.4
DOCUMENTATION
35 TO 36
C.5
PRODUCTION
37 TO 44
C.6
QUALITY CONTROL
45 TO 46
C.7
CONTRACT MANUFACTURE AND ANALYSIS
C.9
DISTRIBUTION, COMPLAINTS AND PRODUCT RECALLS SELF INSPECTION
C.10
CHANGE HISTORY
C.8
47 47 TO 49 50 51
SL. NO.
ANNEXURE
PARTICULARS
01
ANNEXURE – I
Photocopy of Manufacturing Licence
02
ANNEXURE – II
List of Equipments & Instruments
ANNEXURE –III
Layouts detailing men/material movement, General Layout and AHU Classifications,
03
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APPROVAL AND AUTHORIZATION SHEET Group Pharmaceuticals Limited Site-Plot No. 41, KIADB Industrial Area, Malur- Kolar District – 563 130 , Karnataka, INDIA Tel: +91-80-8151-234237; Fax: +91-80-8151-235084 Email:
[email protected]
Sl. No.
ACTIVITY
NAME AND DESIGNATION
DEPARTMENT
1.
Prepared By
Mr. HARIPRASAD.S (Junior Officer QA & Regulatory)
Quality Assurance
2.
Checked By
Mr. A.TRIVIKRAM RAO (Sr. Production Manager)
Production
3.
Checked By
Dr. PROMOD KUMAR JAIN (GM Corporate QC)
Quality Control
4.
Approved By
Mr. RAJESH KAPOOR (GM Corporate QA & RA)
Quality Assurance
5.
Authorized By
Dr. B.S.MAHADEV (Director Technical & Works)
Overall InCharge
SIGNATURE & DATE
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C.1 GENERAL INFORMATION C.1.1 BRIEF INTRODUCTION OF THE ORGANIZATION Group Pharmaceuticals Limited is a closely held unlisted Company with its headquarters in Goregon west Mumbai and marketing office in Bangalore.
Group Pharmaceuticals Limited was founded in 1980, It is engaged in manufacturing and marketing of Liquid (Oral, Syrups, suspensions, mouthwashes), External Preparations and cosmetics across the globe. Group Pharmaceuticals Limited strives to provide high quality pharmaceuticals that improve the health of the customers. A team of personnel of various disciplines and pharmacists are working towards to meet the customers requirements and the objective of continuous improvement in quality.
Group Pharmaceuticals Limited has complimentary production facilities, good marketing network and foreign collaborations too. The company has geared up to march ahead in facilitating its consumers with all the latest developments that has taken place in the pharma market with regards to Oral care healthcare and other pharmaceutical products.
This Site master file is related to GPL, dedicated to manufacturing of External Preparations (Creams, Ointments, Pastes, Gels, Lotions, Solutions) and Liquid (Oral, Syrups, suspensions, mouthwashes) Preparation, located at Plot No. 41, KIADB Industrial Area, Malur- Kolar District – 563 130
Karnataka, INDIA; which is about 53 km from Bangalore City and 20 KM from Hoskote and the nearest railway station is at Malur which is 1.5 km away from manufacturing plant. C.1.2 LICENSABLE ACTIVITIES This site is licensed to manufacture pharmaceutical products under the own manufacturing license number KTK/25/475/2001, KTK/28/339/2003, and KTK/32/268/2006 issued by Drugs Control Department, Government of Karnataka, India.
C.1.3 OTHER MANUFACTURING ACTIVITIES AT THE SITE No other manufacturing activities are performed at the site, other than External Preparations (Creams, Ointments, Pastes, Gels, Lotions, Solutions) & Liquid (Oral, Syrups, suspensions, mouthwashes) Preparation. Formulations like βeta-lactams and cephalosporins drug products are not stored or manufactured.
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C.1.4 NAME AND ADDRESS Group Pharmaceutical Limited
Plot No. 41, KIADB Industrial Area, Malur- Kolar District – 563 130 , Site Address:
Karnataka, INDIA Phone:
+91-(0)-8151-234237
Fax:
+91-(0)-8151-235084
Web Site: www.grouppharma.in W/46 (B) MIDC, Tarapur 401 508 Registered Office:
Thane District, INDIA Phone:
+91-0-2525-272108
Fax:
+91-0-2525-274036
Devraj Building ‘A’ wing Administrative Office
IV Floor, S.V.Road Goregaon west, Mumbai-62 INDIA
Contact persons during and outside working hours Name of person
Office Phone No.
Mobile No.
Mr. Sunil Attavar Managing Director
[email protected]
+91-(0) 080-23376766
+91-(0) 9342838923
Dr. B.S. Mahadev Director (Technical & Works)
[email protected]
+91-(0) 8151-235220/234237
+91-(0) 9343661007
Mr. A.T.Rao Sr. Manager Production
[email protected]
+91-(0) 8151-235220/234237
+91-(0) 9342245271
Mr. Rajesh Kapoor GM Corporate QA & RA
[email protected]
+91-(0) 8151-235220/234237
+91-(0) 9359889460
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C.1.5 TYPE OF PRODUCTS MANUFACTURED AT THE SITE. This site is licensed to manufacture Liquid (Oral, Syrups, suspensions, mouthwashes) & External Preparations-(Creams, Ointments, Pastes, Gels, Lotions, Solutions), No toxic or hazardous substances are handled at the site. The formulations manufactured at this site are for “Human use only”.
LIST OF PRODUCTS MANUFACTURED Liquid (Oral, Syrups, suspensions, mouthwashes) & External Preparation--(Creams, Ointments, Pastes, Gels, Lotions, Solutions): Appendix-I. C.1.6 DESCRIPTION OF THE SITE Group Pharmaceuticals Limited is located at KIADB industrial area, commissioned in Jun.-2001 and started its operation from Mar.-2002. The total area of the land is 4 Acres. The built up area is 42,000 Sq. ft. and is licensed to do Formulation and Testing for formulating External Preparation-(Creams, Ointments, Pastes, Gels Lotions, Solutions) & Liquid-(Oral, Syrups, suspensions, mouthwashes). The unit is located amidst lush green surroundings with non polluting industries like Garment Industry, Pharmaceutical Industry and Petrochemical Industry around. Near By: A) Hospital
:
B) Fire Station :
Manasa Nursing Home Malur– 2 km 40 km (Kolar Tamaka)
Total Land Area
= 4 acres
Built up area
= 42, 000 Square feet (approx.) Equivalent to 3,902 m2 (approx)
Age of Building
= New Facility (March-2002)
Type of Building
= All concrete with Reinforced Cement Concrete Slabs.
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Area of various Modules and Sections Sr. No.
Section – Module I
Area (≈ m2)
01
Manufacturing Area
47.4
02
Tube Filling and Sealing Area
18.4
03
General Washing Area
5.8
TOTAL
71.6 m2
Sr. No.
Section – Module II
Area (≈ m2)
01
Manufacturing Area
40.1
02
Bottle washing Area
20.3
03
Bottle Filling and Sealing Area
34.3
04
General Washing Area
20.2
TOTAL
114.9 m2
Sr. No.
Section – Module I and Module II
Area (≈ m2)
01
Packing Area
77.9
TOTAL
77.9 m2
Sr. No.
Section – Module III
Area (≈ m2)
01
Manufacturing Area
46.3
02
Bottle washing Area
24.8
04
Bottle Filling and Sealing Area
21.8
TOTAL
92.9 m2
Sr. No.
Section – Module III
Area (≈ m2)
01
Packing Area
70.8
TOTAL
70.8 m2
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C.1.7 NUMBER OF EMPLOYEES WORKING IN THE PLANT (Department Wise) DEPARTMENT
CATEGORY Technical
NUMBER OF EMPLOYEES 14
Production-Manufacturing Non-Technical
Skilled -22 & Unskilled-206
Technical
20
Non-Technical
06
Technical
11
Non-Technical
01
Technical
09
Non-Technical
19
Technical
06
Non-Technical
09
Supervisor
01
Labourer
29
Quality Control
Quality Assurance
Warehouse and Distribution
Engineering
House Keeping
Administration
--
12
Security
--
12
Technical
61
TOTAL EMPLOYEES Non-Technical
316
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C.1.8 CONTRACT MANUFACTURE We at Group Pharmaceutical Limited follow Good Manufacturing Practice (GMP) as laid by World Health Organisation (WHO) in respect of manufacturing and testing of pharmaceutical products. Group Pharmaceuticals Limited is currently manufacturing products of their own under the manufacturing licence KTK/25/475/2001, KTK/28/339/2003 & KTK/32/268/2006 and also on contract (LL & P to P) basis under respective manufacturing licence for the below said parties. Sr. No.
PARTY NAME
01.
Dr. Reddy’s Laboratory Limited
02.
Micro Labs Limited
03.
Apex India Limited
04.
Elan India Pvt. Limited
05.
Medreich Pvt. Ltd.
06.
Gepach International Limited
07.
Cipla Limited
08.
Remedia Therapeutic Limited
09.
Sami Labs Limited
10.
Medopharm
11.
Srushti Pharmaceuticals Ltd.
12.
Stiefel India Limited (GSK)
13.
Pharmed
14.
Fittydent International Gmbh
15.
Zentiva Healthcare
16.
Eminent
17.
Juggat Pharma
18.
Sunways
19.
Grandix
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C.1.9 USE OF OUTSIDE EXPERTISE Company uses outside expertise for pest and rodent control, calibrations, filter integrity test, particle counting and need based training. Analysis of all the starting materials, intermediates and the finished products is carried out at the site by our own trained quality control staff. However, analytical services of the following external approved analytical laboratories are utilized during the breakdown or maintenance of any laboratory equipment. Their services are also utilized for speciality tests.
Sl. No 01.
External Testing Laboratory
Tel
No.
Bangalore Test House- BTH
Phone:
080 23388895
BANGALORE – 560 040
Fax:
080 23385979
Shiva Analyticals (India) ltd
Phone:
080 – 5353961
No. 65, 20th main, Marenhalli, Vijayanagar
02.
Plot No. 24D (P) and 34D, KIADB Industrial Area
03.
Hoskote – 562 114
Fax:
Sipra Labs Pvt Ltd.
Phone:
040 – 23734720
Space no. 7, 4th floor, Nilgiri Adidya Enclave
04.
Ameerpet, Hyderabad-560038
Fax:
Ashco Analytical Services
Phone:
040 – 3406557
103, Diamond House, 6-3-83/D3/D4
05.
06.
Behind TOPAZ, Panjagutta, Hyderabad – 500 082
Fax:
A to Z Pharmaceuitcals Pvt. Ltd.
Phone:
042-26585811,
No. 12, Balaji Nagar , Ambattur, Chennai-600053
Fax:
26585855
Medlar Laboratories Pvt. Ltd
Phone:
91-22-25786466,
2nd floor blding no.14, Village Hariyali, Vikhroli(w)
07.
25798330
Mumbai-400083
Fax:
Manisha Laboratories Pvt. Ltd
Phone:
135-A Govt. Industrial estate . Charkop kandivali (W) Mumbai -400067
28699888,28602292, 28683666
Fax:
28602297
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Sl. No 08.
External Testing Laboratory
Tel
No.
Chemi Labs
Phone:
040-23073496
Phone:
080-3343376, 3340395
Fax:
080-3340395
Plot No. 121. Opposite Murthy building, Prashanth Nagar, Kukatpally, Hyderabad-72 09.
General Analytical Laboratory th
th
No.16, 17 cross, 13 main road, Malleswaram, Bangalore-560 055
Other services obtained from the external agencies are as follows; Pest and Rodent Control 1
Phone:
91-080-26679604
F-9, 1 Floor, Basco Court, Gandhi Bazar
Fax:
91-080-26614101
Main Road, Bangalore – 560 004India
Mobile
98455 97918
Pesterad Services st
Calibration of Critical Measuring, recording, weighing instruments. 1.
Phone:
91-080-26530093
Tele-Fax:
91-080-26654488
Mobile
9845046294
SRP ENVIRO SERVICES PVT. LIMITED
Phone:
91-080-22243411
213/60, Ground floor, 11th cross, Wilson Garden,
Tele-Fax:
91-080-22243412
G. SHANKAR RAO
Phone:
91-080-26693694
MAHALASA KUTIR
Tele-Fax:
91-080-26693693
No. 10/19, Ist ‘C’ cross, Near Nandi Enclave Apts.,
Mobile:
9845289612
ACVS Calibration Services of Electrical, Mechanical & Control Instruments Kyaswar mansion, No.: 180/44, 16
th
th
Main, 4 T Block, Jayanagar, Bangalore – 560 041. 2.
Bangalore-560 022. 3.
5th Main, 5th block, Banashankari 3rd stage, Bangalore – 560 085. 4.
ANU POWER SYSTEMS A/4, 32 cross, 3rd Main, Jayanagar 7th block, Bangalore-560 082
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Jet Inks Private Limited
Phone:
91-44-42233200
Old No. 12A, New No.22,
Fax:
91-44-28202327
SRI BALAJI ENGINEERING SYSTEMS
Phone:
91-080-26586647
No. 100, 2nd cross, 3rd Main, Dollar’s Colony,
Mobile:
9844113826
MANIRANJAN DIESEL SALES & SERVICE PVT.
Phone:
91-080-42043737
LTD
Tele-Fax:
91-080-25203035
Nungambakkam High Road, Chennai-600 034. 6.
4th phase, J.P. Nagar, Bangalore-560 078. 7.
#3032A, 8th Main, HAL 2nd Stage, Indiranagar, Bangalore-560 038.
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C.1.10 QUALITY MANAGEMENT SYSTEM .
§
QUALITY POLICY
§
To provide consistently high quality oral health care and other pharmaceutical products to the satisfaction of the medical profession and the consumers.
This is being achieved by cumulative efforts from the top management to the lowest cadre of the workmen by maintaining pre set workman standards aimed at defect prevention rather than defect detection.
We plan to achieve the consistent high quality of products through Best Available Resources Well Trained Personnel Good Manufacturing Practices Stringent Specifications Continual Improvement Program’s
Hence we at Group Pharmaceuticals Limited are totally committed to meet fully the quality and other requirements. Also we are committed to continually improve the effectiveness of the Quality Management System.
Managing Director. Responsibilities of the Quality Assurance Department
Dated:
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• Approve and verify implementation of defined systems, standards and procedures. • Ensure availability of approved procedures and specifications for reference. • Ensure compliance to National and International regulatory cGMP requirements. • Review Batch Manufacturing and Testing Records, before giving product release. • Review and Authorise Validation Master Plan, Protocols and provide support for validations. • Ensure compliance of Change control procedures. • Ensure Induction and training of employees as per the “Induction Manual and Training Guidelines”. • Ensure compliance of cGMP’s through audits. • Carry out Process controls, including in-process checks/ inspections/ line clearances. • Inspection of final packed stock, before release. • Investigate complaints, deviations, quality incidents and non-conformances. • Handling of regulatory inspections at the site. • Take actions on Product recalls and investigate the reasons. • Ensure implementation of amendments in specifications and procedures as per current pharmacopoeial standards. • Review Product stability reports. • Review Batch Manufacturing, Batch Packing Records, verify reconciliation of batch inputs, batch yields and finally release the product. • Document control and ensure proper archival and fast retrieval of records. • Ensure cGMP and cGLP training to the staff. • Evaluation of external analytical laboratories and all those providing the contract services. • Regulatory Affairs. • Evaluation and approval of all vendors supplying materials to GPL. Quality Assurance Department of Group Pharmaceuticals Limited functions and reports to Head Quality and is independent of all other plant functions. Head of Quality Department is technically qualified with
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about 14 years of professional experience in the responsible area. Site Sr. Asst. Manager QA and Executive RA reports to Head Quality. The following flow diagram represents the organizational structure of Quality Assurance function in the Company.
There are approved standard operating procedures for each and every activity carried out at the site. Implementation of these procedures is the responsibility of the user, which is also monitored by a team of trained Quality Assurance officers. General Manager QA approves all the procedures, protocols and reports. For each product, in-process specifications, finished product specifications, analytical procedures and limits are defined and checked by General Manager QA. Approved specifications for Raw Materials and Packaging Materials are also available to control the quality of inputs going into the products. Release of a batch not only depends on the conformance of the intermediates/ finished products to the standard specifications, but also on the review of the Batch Manufacturing Record, Batch Packing Record and analytical reports by Quality Assurance Department. QA Department authorizes the release of the product for sale/ distribution.
Audit programmes
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Self inspections are conducted at the site at defined intervals. Besides self inspections, external audits by regulatory authorities are carried out as per requirements. The audit reports and the compliance report are documented by the site Quality Assurance. We follow National and International cGMP guidelines to audit the Quality Assurance systems within the company and the same approach is extended to our vendor qualification as well. The assessment of Vendors
A documented procedure is available for the assessment, evaluation and approval of vendors. All materials used at the site are obtained from “APPROVED VENDORS” only. Vendors supplying materials are audited as per the schedule and on need basis. QA shall evaluate the performance of the vendor. C.2 PERSONNEL C.2.1 Organisation Chart
Quality Assurance(QA) and Quality Control(QC) Function is independent of all other plant functions. Head QA reports to Managing Director. All other GPL functional departments reports to Director works. C.2.2 Qualifications, Experience and Designation of Key Personnel Academic Qualification
Experience
M.Sc, Ph.D in Microbiology
26 years
Director (Technical & Works)
Mr. Rajesh kapoor
B.Pharma
14 years
GM Corporate QA & RA
Mr. Promod kumar Jain
Ph.D in Chemistry
35 years
GM Corporate QC
Mr. A.T.Rao
B.Pharma.
15 years
Sr. Manager – Production
M.Sc
11 years
Sr. Asst manager QA
Name Dr.B.S.Mahadev
Mr. Gopal Krishna
Designation
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PLANT ORGANOGRAM
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C.2.3 Training
Training has been identified as the key area for updating the skills and cGMP knowledge of personnel engaged in various activities at the site. We have an “Induction Manual”, approved Training SOPs, which provide required guidelines for induction and training of employees at the site. Training needs are identified by the department managers. Based on the identified training needs and the annual training schedule on SOP’s and cGMP’s, training sessions are conducted by qualified trainers of the organization and/or through expertise from external agencies. Training Evaluation is done through questionnaires as applicable.
Training records are compiled in the individual training files of employees by HR in coordination with QA. Training records include attendance sheet, answers to questionnaires, evaluation and trainers comments. Based on Trainers assessment, re-training needs are identified.
C.2.4 Health Requirements for Personnel Engaged in Production
A qualified and experienced consulting medical specialist, appointed by the organization is responsible for checking the health of the employees.
All employees have to undergo a pre-employment medical check-up to demonstrate that they are healthy and free from contagious diseases.
All employees are medically checked annually and their state of health reviewed. On recommendation by the doctor, corrective action is taken for the employee concerned. For employees engaged in visual checks/colour checks/ packaging performance checks (e.g. Quality Control Chemists), the routine check also includes eye testing.
All employees are advised to report any sickness, including sickness of their family members.
All
employees reporting sickness have to produce a fitness certificate before being allowed to work in specified areas such as Production, Engineering, Stores, Quality Control and Quality Assurance.
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C.2.5 Personnel hygiene requirements and clothing.
Personnel entering the production area have to undergo primary and secondary change in the respective change rooms, as per defined entry and exit procedures.
Primary change is the change from street clothing and footwear to factory uniform and footwear.
Secondary change involves wearing of protective clothing and change of footwear. Persons who are in direct contact with the product will undergo the secondary change uniform of respective module’s to ensure high level of work comfort.
There is an approved procedure for gowning and de-gowning procedures. A dedicated bin for collection of used linen is provided.
The Plant has been provided with change rooms and hand wash facilities. Employees are trained in the gowning procedures, which are displayed in the change rooms.
Employees are also trained in hygiene aspects, which are regularly monitored by production supervisors and QA Officers. Photographs displaying gowning procedure are also displayed in the change rooms
C.3.0 PREMISES AND EQUIPMENT C.3.1 Premises The premises comprises of Liquid (Oral, Syrups, suspensions, mouthwashes) and External Preparation (Creams, Ointments, Pastes, Gels, Lotions, Solutions) block, warehouse block, Utilities block, Record room, Quality Control & Microbiology block.
General Layout of the premises and equipment are enclosed. Annexure- III
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C.3.2 Nature of construction and finishes of critical areas
MANUFACTURING BLOCK: The core production area, warehouse (includes raw & packaging materials & finished goods area) & water system in the ground floor; utilities (AHU and chiller) in the first floor.
The foundation of the facility has been given anti termite treatment. The terrace has been treated with waterproof compounds. The periphery of building is constructed of brick walls, cement masonry and reinforced concrete cement (RCC) roof. The flooring of the manufacturing areas, primary & secondary packing areas and the corridors are coated with non-shrinking hard coatings of resin (epoxy resin). Wall to floor and wall to ceiling covings ensure easy cleaning of GMP area.
The corridors are designed to enhance viewing of the manufacturing operations without physically entering the processing areas. All doors and the windows are flushed to the wall and have a smooth finish. Each processing area is provided with an independent flush door. All entrance points to the facility have list of authorized entry of personnel.
There are separate storage areas for raw materials, packing materials, printed packaging materials and finished goods. UPS system provides lighting in the Manufacturing and Packing Area during power failures. All the ducting, electrical lines and utility lines are either taken above the false ceiling or concealed within the wall. All the luminaries are flushed with the ceiling and electrical control panels and the switches are flushed with the wall.
PACKAGING AREAS: Construction and finishing of primary packaging areas is similar to process areas. The roof is of RCC and Floor is epoxy coated. Entry to secondary packaging and manufacturing areas are separate. Primary and Secondary packaging areas are separated from each other.
WAREHOUSE: Construction and finishing of warehouse areas is similar to process areas. The roof is of RCC and Floor is epoxy coated. Doors are made-up of aluminium. Security to warehouse is ensured by providing iron shutters at the entry point. An unloading bay in warehouse is made for ease of loading & unloading activities.
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C.3.3 Brief description of AHU system:
Technical specifications
Processing and Primary packing areas (AHU- Class D)
Type
Re-circulation
Quality of air
Complies to clean room at rest condition
Temperature
Between 25°C + 2°C
Relative humidity
Not more than 75%
No. of air changes
Not less than 20 Per hour
Pressure differential Filter Configuration
Corridor / Secondary change room (Ventilation)
NMT 30°C
Corridor is not less than 0.5 mm of WC with respect to adjacent areas. Filter
Efficiency
10µ (in AHU mixing chamber)
90%
5µ (in AHU mixing chamber)
99.5%
0.3µ (HEPA) at terminal filtration
99.97%
All three module have independent air handling units to achieve required temperature and air quality standards of class 1,00,000. Exhaust systems are fitted with 20µ filters on discharge side for ventilation system. Manufacturing, filling and sealing area is provided with temperature and humidity control system, other area has only temperature control, terminal filters are provided only in necessary areas. Service floor is provided in the building on the first floor level for AHU’s and ducts are above the false ceiling.
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C.3.4 Brief description of the water system
A schematic diagram of the De-mineralised water system, which is an ion-exchange type is given below. Purified water is at ambient temperature.
Water is sourced from bore well and is stored in under ground raw water storage tank. This raw water is used for domestic purposes and as input for the DM water plant. The capacity of the de-mineralised water plant is 2 KL per regeneration.
A loop system is provided for the distribution of purified water. Distribution supply lines are made of Stainless Steel 316 material.
a) Pre-treatment of water. Raw/ Portable water is passed through Sand filter to filter the foreign particles followed by chlorination.
b) DM- unit Pre-treated water is passed through activated carbon filter to remove the chlorine content, then water is passed through Cation bed, Anion bed, Mixed bed followed by 5µ, 1µ cartridge filter and UV light. Finally purified water is collected in two storage tanks (Stainless Steel 316 tank) of capacity 4,500 Ltrs. Each.
c) Distribution system Circulated in loops to all the user points.
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Figure 3.9: Raw water system at Group Pharmaceutical Limited Sand Filter
Chlori nation
WATER FROM BORE WELL
D.M.PLANT
TOILETS
25,000 LITERS STORAGE TANK
25,000 LITERS STORAGE TANK
KITCHEN
QC
Water is sourced from bore well and is stored in under ground storage tank of capacity 25,000 Liters. This raw water is passed through sand filter followed by chlorination and stored in under ground storage tank of capacity 25,000 Liters which is used for domestic purposes and as input for the DM water plant. Raw water is supplied through a GI pipe.
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Figure 3.10: Schematic diagram of the de-mineralised water plant
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a)
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Potable/Raw water direct from bore well is tested at the sampling points with the following frequency: Sampling Point No. S1
Details Raw water sampling point before Chlorination
Types of water
Frequency Sampling
Potable Water Monthly Twice
b)
S2
Raw water sampling point after Chlorination
Potable Water
S3
Outlet of Activated Carbon Bed unit
Potable Water
Weekly Once
S4
After Mixed Bed
Purified water
Weekly Once
Purified water sampling points and their testing frequencies are as follows.
Chemical and Microbiological analysis Sampling Point No.
Details
Types of water
S5
After Storage tank
Purified
S6
User Point -1 : Module II Manufacturing
Purified
S7
User Point -2 : Module II Bottle Washing
Purified
S8
User Point -3 : General Washing Area
Purified
S9
User Point -4 : Module I Manufacturing
Purified
S10
User Point -5 : Module I Washing
Purified
S11
User Point -6 : Module III Manufacturing
Purified
S12
User Point -7 : Module III Bottle Washing
Purified
S13
Return loop to before Purified water storage Tank
Purified
S14
After UV Light
Purified
Frequency Sampling Daily
Daily One User Point.
Weekly Once
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1. SPECIFICATIONS OF POTABLE/RAW WATER - IH TESTS
SPECIFICATIONS
Description
A clear, colourless, odourless and tasteless liquid.
Turbidity
Should be absent
pH
Between 6.5 to 8.5
Hardness
For Information
MICROBIAL CONTAMINATION TESTS
ACCEPTANCE CRITERIA
SPECIFICATIONS
(i) Total viable aerobic count
Not more than 500
As per current BP/IP.
CFU / ml (ii) Test for specified organism (a) Escherichia coli.
Absent
(b) Pseudomonas aeruginosa
Absent
(c) Staphylococcus aureus
Absent
(d) Salmonella
Absent
*NOTE: Current version of the document shall be valid as on date.
In-house test additionally tested.
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2. SPECIFICATIONS OF PURIFIED WATER- IP/BP TESTS
SPECIFICATION
Description
A clear, colourless, odourless and tasteless liquid.
Conductivity at 25°c
NMT 4.3 µ S cm -1
pH
Between 5.0 to 7.0
Ammonium
NMT 0.2 ppm
Calcium and magnesium
A pure blue colour is obtained.
Heavy metals as Lead
NMT 0.1 ppm
Chlorides
The resulting solution shows no change in appearance for at least 15 min.
Nitrates
NMT 0.2 ppm
Sulphates
The resulting solution shows no change in appearance for at least 1 hour.
Residue on evaporation
NMT 0.001% w/w
Acidity or alkalinity
Should comply
Oxidisable Substance
The solution remains faintly pink.
MICROBIAL CONTAMINATION TESTS
ACCEPTANCE CRITERIA
SPECIFICATIONS
(i) Total viable aerobic count
Not more than 100 CFU/ml
As per current BP/IP.
(a) Escherichia coli.
Absent/ml
(b) Pseudomonas aeruginosa
Absent/ml
In-house test additionally tested.
(c) Staphylococcus aureus
Absent/ml
(d) Salmonella
Absent/ml
(ii) Test for specified organism
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C.3.5 Maintenance and servicing of Air Handling and Water Systems
CLEANING OF AIR HANDLING SYSTEM
The pre-filters are dismantled and cleaned using vacuum cleaners. The filters are then washed using a soft nylon brush. The filters are allowed to dry, and after drying the integrity of the filters is checked by visual inspection. The filters are then put in the system. The frequency of filter cleaning is: - weekly once
5-micron/10-micron filters: as per approved schedule and if any incident of pressure differential crossed beyond the standard limits.
HEPA filters shall be replaced if any damages or incidents of pressure differential crossed beyond the standard limits. Annual filter integrity test (non-viable count) is conducted at least once a year or as on need basis.
CLEANING, SANITATION & PASSIVATION OF WATER SYSTEM
Purified Water loop is sanitized at a predefined frequency schedule by circulating hot de-mineralised water & Passivation is done every year. There are approved procedures for cleaning of air handling units and water systems. Log books are maintained for cleaning activities.
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C.3.6 Major Production & Quality control laboratory equipments
The production department has all the required equipments/ machinery to carry out the activities of batch manufacturing and packing. All equipments are cGMP compliant. Product Contact parts are made of Stainless Steel 316. It is also ensured that, equipment design facilitates easy cleaning and operation.
Major equipments in -production department. Sl. No.
Equipment details 1.
Manufacturing Tank (2,500 Ltrs)
2.
Manufacturing Vessel (1,600 Ltrs.)
3.
Sugar Syrup Vessel (2,000 Ltrs.)
4.
Dispersion Vessel (600 Ltrs.)
5.
Storage Vessel (1,200 Ltrs. & 500 Ltrs.)
6.
Filter Press
7.
Heating Jacketed Kettle
8.
64 Head bottle washing machine
9.
4- Head Filling Machine
10.
8- Head Mono block Filling & sealing Machine
11.
Automatic Cap Sealing machine
12.
Bung pressing machine
13.
Sticker labelling machine
14.
Gum labelling machine
15.
Cream and gel manufacturing vessel (1,000 Ltrs.)
16.
Tube filling and sealing machine (90 to 120 tube per minute)
17.
Overprinting machine
18.
Ink jet printer
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Major equipments in Microbiology Laboratory.
Sl. No.
Equipment details
1.
Incubators
2.
Autoclave
3.
Microscope
4.
Laminar Air Flow
5.
Colony counter
6.
Refrigerators
Major equipments in Quality Control. Sl. No.
Equipment details
1.
High Performance liquid chromatographs
2.
UV – Visible spectrophotometer
3.
K.F. Titrator
4.
Weighing Balance
5.
Potentiometer
6.
UV Chamber
7.
Polarimeter
8.
pH- meter
9.
Hot Air Ovens.
10.
Conductivity Meter
11.
Fume Cupboard
12.
Refractometer
13.
Fluoride Ion meter
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C.3.8 Maintenance and servicing of equipments
In order to ensure that all equipments and machines perform effectively, planned preventive maintenance is carried out by the site Engineering Department.
Detailed procedures for preventive maintenance are available, which define the frequency of preventive maintenance. The procedure includes a preventive maintenance checklist for each and every equipment/ machine.
Records for preventive maintenance carried out are maintained.
If any equipment/ machine is not available for preventive maintenance, or preventive maintenance cannot be carried out for some reason or the other, an alternate date is scheduled and authorised by the Production personnel in coordination with engineering & QA.
Few equipments/ machines are serviced by external agencies at agreed frequencies. Laboratory equipments are put under annual service contract with outside agencies.
Records of preventive maintenance by the external agencies are also maintained and reviewed by QA Manager or his authorized QA person.
If any equipment/ machine needs servicing, the operator of the equipment reports to the department manager through his supervisor. A request for service is then forwarded to the Engineering Department with details of the service required and the date on which the servicing of the equipment can be done.
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C.3.9 Qualification, Validation and Calibration
Company’s validation plan and philosophy is defined in “Validation Master Plan” of the site.
The approach is to establish consistency in product quality through validated processes, using qualified equipments in a facility that has been qualified to meet the designed specifications with respect to area and environment. This is backed up by using validated support services and analytical methods.
Before any validation exercise begins, protocol is prepared, checked and approved. Validation is performed and then reports are compiled, evaluated. Conclusion is drawn, which is reviewed by designated technical heads and finally signed off with comments and remarks.
Components of validation protocol and report are:
Index, Objective, Scope, Responsibility, Validation team, Procedure, Acceptance criteria, Revalidation Criteria, Data generation as per protocol, Data Compilation and Evaluation, Summary, Conclusion, Approval of Conclusion.
EQUIPMENT QUALIFICATION
Equipments are subjected to DQ, IQ, OQ & PQ as per pre-approved protocols. Operating, cleaning & maintenance procedures are written down and approved. Maintenance schedules are defined. Critical Instruments attached to equipment are calibrated. Vendor of the equipment becomes a part of validation team. Validation reports are reviewed and concluded and finally signed off.
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PROCESS VALIDATION
First three consecutive batches of each product shall be validated to ensure that the manufacturing process consistently produces the product to meet the pre-determined specifications. Any change, thereafter is through change control approval. If the change asks for revalidation of process, the same is again carried out. Validation activities shall be executed through approved protocols and SOPs shall be strictly adhered. SOP shall take precedence over protocol for all compliances.
Annual Product Reviews shall be carried out for all the commercial products manufactured during the year as per defined procedures.
Process is considered for validation, whenever there is a technology transfer of a product from Formulation development or from the product owner to the manufacturing site. Process Validation is applicable for the following batches. New product is manufactured. Existing product, undergoes a change in process, formula, source of active ingredient or equipment. The results of process validation must reveal consistency in product quality attributes.
Validation is initiated with writing of protocol and its approval. The Protocol describes the objective, scope, validation team with their responsibilities, procedure, product specifications with acceptance criteria, formula, batch details, equipment to be used with their standard operating procedure numbers, re-validation criteria, stability, documentation and modalities for preparation of summary report. Validation is carried out as per protocol.
The results of the various activities are recorded. Based on these results, a validation report is prepared and a conclusion arrived at after review of the results.
The process is termed validated if defined process meets all the acceptance criteria as mentioned in the protocol. The validation protocol along with the report is maintained by Quality Assurance after approval of the report. If at any stage, the process is found to be unacceptable, then a suitable corrective action is initiated.
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REVALIDATION : Qualified equipment undergoes major modification, replacement of critical spares that shall affect equipment performance. Location of equipment is changed. Facility Modification. Modification/ Change in support services. Change of cleaning agent/method. Process/ Formula Change. Change of any critical equipment in the chain of equipments used for product manufacturing. Change in analytical method etc.
Based on sufficient trend data, the process/ specification parameters are reviewed and tightened.
EQUIPMENT / INSTRUMENT CALIBRATION:
List of Laboratory equipments, measuring, recording, weighing devices that require to be calibrated has been drawn out by site technical people in co-ordination with maintenance engineer.
Method of calibration and frequency is defined for each laboratory equipment and critical instruments. Out of Calibration equipment/ instrument is reported immediately to QA Manager and concerned department in-charge. Impact of out of calibration is assessed & actions taken. Replacement is recorded.
Calibrated equipments/ Instruments are labelled. Date of calibration and next due is highlighted on the label. Out of calibration equipments/instruments are conspicuously labeled “out of Calibration, not to be used”.
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C.3.10 Cleaning procedures for manufacturing areas & equipments
CLEANING PROCEDURES
Well defined, approved procedures for cleaning of the manufacturing areas are available. The procedure covers the following:
(i)
Persons responsible for cleaning activity.
(ii)
Frequency of cleaning.
(iii)
Cleaning devices to be used.
(iv)
Cleaning agents to be used, their concentration and mode of preparation.
(v)
Rotation of cleaning agents.
(vi)
Cleaning methods.
(vii)
Recording of cleaning activity.
(viii)
Cleaning and storage of cleaning devices.
The cleaning activity is carried out at specified intervals. The record of cleaning is maintained along with the cleaning agents used and their concentration. Cleaning activity is checked by responsible person.
For individual equipment, a detailed cleaning procedure has been established. The procedure covers cleaning procedure to be followed during batch changeover as well as product changeover.
The cleaning was done as per the defined procedure. The samples were collected by both (i) swab method and (ii) rinse method.
The samples were tested for presence of traces of previous product by the validated method. Carry over of traces of previous product in the single dose of next product has been proved to meet the norms of cleaning validation.
Filter cleaning procedures, cleaning frequency for AHU’s and dust extraction systems are defined and the activities are recorded. Regeneration of water system and sanitation of water systems is done as per defined procedures and frequency.
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C.4.0 DOCUMENTATION C.4.1 Documentation Preparation & Control
A well-defined system of document control is followed by the site. There is an approved procedure which explains the system of document preparation, revision, distribution, storage and destruction of the obsolete documents.
All documents are identified by their title and a unique document number with revision level and date of next review. Master copies of all the documents are maintained by the site Quality Assurance Department. Photocopies of the MASTER COPIES are issued to the user departments as a CONTROLLED COPY and or DISPLAY COPY, which are identified with blue colour stamps. The procedures are reviewed every two years or and when any change occurs. When document is revised, the master copy is retained as Obsolete copy and the other copies are destroyed.
QA Manager or his authorized QA personnel is responsible for distribution of documents through document control system.
There is an approved standard procedure for preparation of Standard operating procedures. Personnel from the respective departments prepare standard operating procedures.
They are checked by department
managers and finally authorised by Quality Assurance Head.
Specifications for raw materials, packing materials, intermediates and finished products are prepared by the Quality Control Department personnel, checked by Jr. Manager Quality Control, Approved by QC Head and authorized by QA Head and finally adopted for commercial production.
There are approved documents for
Product/ Process Specifications.
Raw Material Specifications.
Packaging Component specifications.
Master, product Specific Batch manufacturing and packing records.
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Product master formula.
Analytical methods.
Recall procedures
Utility Procedures.
Validation Protocols.
Maintenance Procedures.
Pest and Rodent control Procedures.
Health and Hygiene.
Batch Release Procedures.
Training Procedures.
Quality Policies.
Cleaning Procedures.
Master formula/ Product Manual exists for each product. Batch manufacturing record is prepared as an extract from the master formula/ product manual. The master formula/ product manual and batch record for each product is available with Quality Assurance Department. Whenever there is a requirement from production for a batch record, master batch record is photocopied and each page is authorised by the Quality Assurance personnel before being issued to production. A logbook for issue of Batch Records is maintained by QA personnel.
All the completed batch records from production department are returned to Quality Assurance for the final review and release. Quality Assurance holds the sole responsibility to release the batches. The released batch records are retained with Quality assurance till one year after the expiry of the product.
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C.5.0 PRODUCTION C.5.1 Brief description of production operations.
The site is licensed to manufacture Liquid (Oral, Syrups, suspensions, mouthwashes) & External Preparations as Creams, Ointments, Pastes, Gels, Lotions, Solutions. The site is fully equipped to manufacture and pack these products. Flow diagrams of the process- Oral Liquid (Syrups) APPROVED RAW MATERIALS DISPENSING
PREPARATION OF SUGAR SYRUP
ADDITION OF ACTIVES, INACTIVE, COLOURS AND FLAVOURS
MIXING
BULK TESTING & RELEASE BY THE QCD
FILLING
QA RELEASE FOR PACKING
PACKING MATERIAL ISSUANCE
PACKING
FINISHED PRODUCT TESTING & RELEASE BY THE QCD
QA RELEASE
DISPATCH
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Flow diagrams of the process- External Preparations (Creams & Lotions) APPROVED RAW MATERIALS DISPENSING
PREPARATION OF OIL PHASE AND
PREPARATION OF WATER PHASE
ADDITION OF ACTIVES, INACTIVE, COLOURS AND FLAVOURS
MIXING
BULK TESTING & RELEASE BY THE QCD
FILLING
QA RELEASE FOR PACKING
PACKING MATERIAL ISSUANCE
PACKING
FINISHED PRODUCT TESTING & RELEASE BY THE QCD
QA RELEASE
DISPATCH
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Flow diagrams of the process- External Preparation (Toothpaste)
APPROVED RAW MATERIALS DISPENSING
GUM SOAKING
ADDITION OF ACTIVES, INACTIVE, COLOURS AND FLAVOURS
MIXING
BULK TESTING & RELEASE BY THE QCD
FILLING
QA RELEASE FOR PACKING
PACKING MATERIAL ISSUANCE
PACKING
FINISHED PRODUCT TESTING & RELEASE BY THE QCD
QA RELEASE
DISPATCH
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Flow diagrams of the process- External Preparation (Mouthwash) APPROVED RAW MATERIALS DISPENSING
PREPARATION OF ACTIVES, INACTIVE, COLOURS AND FLAVORS
ADDITION OF ACTIVES, INACTIVE, COLOURS AND FLAVOURS
MIXING
BULK TESTING & RELEASE BY THE QCD
FILLING
QA RELEASE FOR PACKING
PACKING MATERIAL ISSUANCE PACKING
FINISHED PRODUCT TESTING & RELEASE BY THE QCD
QA RELEASE
DISPATCH
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C.5.1 Brief description of material receipt and labelling. Upon receipt of the raw materials/packing materials, the material is unloaded on the receiving bay. The correctness of the material received is checked with the delivery note. The details are logged in the inward register. Supplier’s batch number and the quantities are cross verified. A goods receiving note is prepared and affixed on each and every packs. Sampling is done by trained samplers as per the approved procedure. Sampled containers are labeled with “UNDER TEST” label in yellow. The label indicates name of the material, item code number,
batch number of the supplier, analytical report number, date of manufacturing, date of expiry and the retest date. Anaytical report number is assigned to each lot of material received. The material is identified with this number. Samples are analysed as per the approved specifications. If the sample complies with the approved specifications, an “APPROVED” label in green is affixed and if it does not meet the specifications , a red “REJECTED” label is affixed on the pack (s).
Sampling as per the sampling procedure. Approved materials are transferred from quarantine to the approved area and the rejected materials are moved to secured rejected material area. Materials are accepted only from the approved vendors. The list of appoved vendors is
available in warehouse. Dispensing of materials is a controlled operation carried out by stores personnel in presence of production and quality assurance personnel. Dispensing and sampling of raw materials is done under class 10,000 condition. Materials are issued by stores on receipt of authorised requisition sheet, which is a controlled document and approved by QA Manager or his authorised deputy. Dispensing is done by using calibrated balances.
Line clearance procedures are followed for all manufacturing and packing operations. Identity
of materials at processing stage is confirmed by reading dispensing labels. Weights are counter checked. The dispensed raw materials are processed as per the instructions defined in the product specific batch manufacturing record.
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In-process control/ tests are carried out as per the frequency and procedure defined in product specific batch records. In-process checks are conducted by Production and the Quality assurance, independently at defined intervals.
Intermediate products are analysed and approved by the Quality control prior to the packing operation. The finished product is transferred to the finished product quarantine area. The goods are released for despatch after the completion of the finished product analysis and the review of the batch documents and the analytical reports by Quality Assurance. Products released by Quality Assurance are transferred to the finished product storage area for despatch. Control of non-conforming products A procedure for control of non-conforming products has been evolved, covering raw materials, packing materials, intermediates and finished products. If raw material is not conforming to the specifications, it is labeled “rejected” and is isolated. It is sent back to the vendor. If printed packing material is rejected, it is isolated and destroyed at the site in the presence of the vendor. A record of the destroyed material is maintained. If any intermediate or finished product is found to be non-conforming, it is isolated and marked with the appropriate label. It is then referred to the Quality Assurance Manager, who investigates the problem. The matter is referred to technical team for action. Reprocessing and reworking will be considered if there is a need and technically justified. Details of any non-conforming products and any corrective action taken are recorded and a record is maintained
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Raw material and Packaging Material Flow Chart
Raw Material & Packaging Material
Checking of Containers & Documents
“Quarantine” Area
“Under Test” Yellow Label on all sampled packs
Only Raw Materials Back to Supplier only
Sampling by QC
Quality Control Department
Printed Packaging Materials Shall be destroyed at the site
Shifted to Rejected Area
Goods Receipt Note Preparation
“Rejected” Red Label on all packs
Rejected
“Approved” Green Label
Testing as per Specifications
Approved
Shifted To Approved Area
Raw Material & Packaging Material Requisition from Production
Dispensing
Processing
Despatch
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Finished Product - Flow Chart
Approved Materials Requisition from Production Issuance of Batch Record
Dispensing
Manufacturing Processing
Analytical Report Review (QA)
Batch Record Review (QA)
In-Process Checks
Authorization for Release by Quality Assurance
Transfer to Finished Goods Store
Despatch
•
BMR: Batch Manufacturing Record
•
BPR: Batch Packing Record
As per Controlled Batch Manufacturing Documents • BMR & BPR
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C.6.0 QUALITY CONTROL C.6.1 Brief description of quality control system. Quality control department has experienced, competent and technically qualified personnel to shoulder various activities of the department. The head of quality control has sufficient experience in the Quality control functions, as applicable to pharmaceutical formulations. Quality Control personnel is responsible for sampling and analysis shall is done by Trained Quality Control personnel as per approved specifications. Release/reject authority for all raw materials, packing materials, intermediate products and finished products lies with quality control only, but final release authority for product lies with Quality assurance. The laboratory has been designed and equipped with facilities for chemical, instrumental, microbiological
and
stability
testing.
Instrumental
room
is
temperature
controlled.
Microbiological area is provided with laminar airflow and other facilities to carry out limit tests and environment monitoring. The instruments used for the analytical purpose are operated and calibrated as per the respective operating and calibration procedures. All working standards used are carefully selected and analysed. They are analysed by two separate experienced analysts in duplicate, Reference standards are necessary if the assay method used is a comparative method such as HPLC and In case if any of the required reference standard is not available in the lab to perform the required test, then a portion of the sample to be sent to an approved testing lab and get it analyzed in duplicate, so as to assess their suitability for use as a working standard. The storage conditions for the working standards as well as their validity for use are specified and all the relevant documents are maintained.
All volumetric solutions used in tests are prepared from material of a suitable grade in accordance with the approved procedures.
Standardization of volumetric solutions is
performed by experienced analysts. The results are verified and records are maintained. Containers holding volumetric solutions are labelled with details like name of the solution, strength of solution, date of preparation, date of standardization, use before date, and the initials of the person who standardized and checked the solution.
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The microbiology laboratory is handled by a qualified microbiologist, who has the appropriate experience
in
carrying
out
bio-burden
monitoring,
microbial
counts
and
pathogen
characterizations etc.
Staff recruited to the Quality control department undergoes initial training for analyst validation to ensure the technical competence. Quality control plays an active role in the validation activities. Quality control department provides analytical support for process and cleaning validation samples. Quality Assurance reviews the validation data prior to final approval. RETENTION/ CONTROL/ RESERVE SAMPLES: From each batch of a drug product defined quantity in original primary/secondary packing is randomly selected for retention.
They are retained for 1 year after the shelf-life of the
product and stored under the specified storage conditions. These samples subjected for visual inspection, once in a year. Defined quantity of each drug substances and excipients also is being stored as a control samples, retained for minimum for one year after the expiry date. STABILITY STUDIES: Stability studies are carried out as per ICH guidelines and pharmacopoeial requirement as mentioned below. 40oC/75% RH 30oC/65% RH 25oC/60% RH For developed and existing products, stability is also studied under the specified storage conditions till the end of shelf life as specified, to confirm its ability to comply with the specifications set for that product. The stability chamber are controlled for recording the temperature and humidity conditions. GPL has sufficient stability chamber with respect to the conditions.
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C.7.0 CONTRACT MANUFACTURE AND ANALYSIS
C.7.1 Brief description of contract acceptor and giver.. No Contract Manufacturing facilities are utilized. The site manufacturers and analyses products under drug controller approved license. Complete analysis is carried out in-house. However, in-case of any additional requirement/ breakdown of instruments/ equipment, Group Pharmaceuticals Limited utilizes the services of external, approved analytical laboratories.
C.8.0 DISTRIBUTION, COMPLAINTS AND PRODUCT RECALL
C.8.1 Brief description of distribution system. Adequate area is provided at the site for the storage of finished products as per the product requirements. Products are stored to a specified height with proper segregation. Released Products are despatched in closed pre-inspected vehicles or containers. The Products are despatched to end distribution warehouse, who shall maintain the distribution records at their end. The products are dispatched by road, sea shipment or by air route as per logistics requirements. Product distribution is the responsibility of our customers/ product owners/ contract givers.
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C.8.2 Handling of Complaints Schematic Flow chart of handling Market Complaints
Forwarding the complaints received to Quality Assurance Department Complaints other than Medical in Nature Documentation of all available information in Market complaint format by Assign Market Complaint number & forwarded to GM QA. Along with samples labelled (if any).
GM Forwards this duly filled format along with samples if any to QA manager for investigation.
QA Manager categorizes the complaint Critical/ Major/ Minor
QA Manager in coordination with the concerned department shall arrange investigation
Record the details of Investigation in the Investigation Report, Draft the reply is prepared and forwarded to GM QA for approval.
QA Manager shall forward the approval reply to Head Marketing with a copy to GM QA.
Head Marketing shall reply to the complainant with a copy to Head QA & GM QA within 30 working days
Complaint records are maintained at the site by the site QA manager. Complete record contains complaint details, investigation report, response to complainant and closure of complaint handling process.
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C.8.3 Product Recalls Schematic Flow chart of Product Recall
Head Quality & Recall committee
Intimate to contract giver if product belongs to them
Head QA investigate & recommend for product recall as per SOP
Head QA shall fill the format for product recall/withdraw by assigning product recall number Forward the duly filled format to Director technical & works for approval Head QA Issues the recall notification to Marketing/ Supply chain department for stoppage of sales and distribution & copy to Regulatory Authority
Marketing/ Supply chain department shall issue the recall notification letter to the regional manager/distribution manager
Regional manager/distribution manager shall issue the recall notification letter to C & F agents / Stockiest.
Warehouse / depot in-charge shall do complete reconciliation the total batch quantity and send report to the Head Marketing, Director technical & works, Head QA.
Head QA shall prepare a summary report and inform to the Director technical & works and a copy to regulatory authorities.
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C.9.0 SELF INSPECTION
C.9.1 Brief description of self inspection system. Self inspection has been identified as one of the key tools for self improvement. Hence a procedure has been evolved for carrying out self inspections. Departments, whose activities directly or indirectly affect the quality of the product are audited once every six months. The audit team comprises of the Quality Assurance Manager, Quality Control Manager, Production Manager and Manager Engineering or any designated auditor(s) as per the audit schedule.
QA Head / management representative will lead the
audit team. Out of two inspections in the year, one audit will be conducted as per the readily available checklist which is a part of the approved SOP for self inspection and the other audit is carried out without the checklist.
The audit consists of verification of all documents,
personal discussion with the concerned auditee’s and verification of the activities being carried out on the day of the audit and GMP Compliance. Based on the observations of the audit team, audit leader prepares an “Audit Report”, listing system non-conformances, procedural errors and deviations by classifying them as critical, major and minor. The corrective actions are suggested if possible and the report is forwarded to the Head of QA / Management representative and thereafter to the Management for Final Approval. The audit report is then reviewed and analyzed by the Head QA / Management representative and the concerned Department Manager. A time bound corrective and preventive action plan to address non-conformance is agreed upon and initiated. Responsible person to implement the action plan is also identified. The corrective and preventive action is implemented by the respective
department
in-charge
and
the
Quality
Assurance
manager
ensures
the
implementation. The effectiveness of the corrective action is verified subsequent to audit. The nonconformance report raised is closed by the auditor after implementation of the action plan. Quality Assurance Manager maintains.
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C.10 CHANGE HISTORY Version
Supersedes
SMF/GP/01
SMF/GP/00
i) Periodic review
SMF/GP/02
SMF/GP/01
ii) Periodic review
SMF/GP/03
SMF/GP/02
iii) Periodic review
SMF/GP/04
SMF/GP/03
iv) Periodic review
SMF/GP/05
SMF/GP/04
v) Periodic review
SMF/GP/06
SMF/GP/05
vi) Periodic review
SMF/GP/06
i) Effective date NOVEMBER 2009 ii) Inclusion of Updated Organogram iii) Inclusion of Purified Water Specification & flow chart iv) Flow chart of Product Recall and Market Complaint updated. v) Updation of Employee strength.
SMF/GP/07
SMF/GP/08
SMF/GP/07
Changes made
i) ii) iii) iv) v)
Effective date APRIL 2010 Approval & Authorization sheet Contact persons during outside working hours Organizational structure of Qualilty Assurance Qualifications, Experience and Designation of key personnel vi) Plant Organogram vii) Change history
THIS IS THE END OF THIS DOCUMENT Annexure I
:
Photocopy of Manufacturing License and list of products licensed for commercialisation. Annexure II : List of equipments & Instruments. Annexure – III
:
Layouts detailing men/ material movement (General Layout) and AHU Classifications NOTE :
All of the above Attachments have been collated into a File.
Any updates to the annexure(s) shall be filed as on date accordingly.
Confidential
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