Example Site Master File PDF

SITE MASTER FILE
DOCUMENT NO. SUPERSEDES DOC. NO. EFFECTIVE FROM PAGE NO.
SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 1 OF 51
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 47

DISTRIBUTION, COMPLAINTS AND PRODUCT
C.8 47 TO 49
RECALLS
C.9 SELF INSPECTION 50
C.10 CHANGE HISTORY 51
SL. NO. ANNEXURE PARTICULARS
Photocopy of Manufacturing
01 ANNEXURE I
Licence
List of Equipments &
02 ANNEXURE II
Instruments
Layouts detailing
men/material movement,
03 ANNEXURE III
General Layout and AHU
Classifications,
SITE MASTER FILE
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: groupmalur@grouppharma.in
Sl.
ACTIVITY NAME AND DESIGNATION DEPARTMENT SIGNATURE & DATE
No.
Mr. HARIPRASAD.S
Quality
1. Prepared By (Junior Officer QA &
Assurance
Regulatory)
Mr. A.TRIVIKRAM RAO

2. Checked By Production
(Sr. Production Manager)
Dr. PROMOD KUMAR JAIN

3. Checked By Quality Control
(GM Corporate QC)
Mr. RAJESH KAPOOR Quality

4. Approved By
(GM Corporate QA & RA) Assurance
Dr. B.S.MAHADEV Overall In-

5. Authorized By
(Director Technical & Works) Charge
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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 eta-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 ,
Karnataka, INDIA
Site Address:
Phone: +91-(0)-8151-234237
Fax: +91-(0)-8151-235084
Web Site: www.grouppharma.in
W/46 (B) MIDC, Tarapur 401 508
Thane District, INDIA
Registered Office:
Phone: +91-0-2525-272108
Fax: +91-0-2525-274036
Devraj Building A wing
IV Floor, S.V.Road
Administrative Office
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 +91-(0) 080-23376766 +91-(0) 9342838923
sunilattavar@grouppharma.in
Dr. B.S. Mahadev

Director (Technical & Works) +91-(0) 8151-235220/234237 +91-(0) 9343661007
dr.bsmahadev@grouppharma.in
Mr. A.T.Rao
Sr. Manager Production +91-(0) 8151-235220/234237 +91-(0) 9342245271
atrao@grouppharma.in
Mr. Rajesh Kapoor

GM Corporate QA & RA +91-(0) 8151-235220/234237 +91-(0) 9359889460
rajeshkapoor@grouppharma.in
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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 : Manasa Nursing Home Malur 2 km
B) Fire Station : 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. Area
Section Module I
No. ( 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. Area
Section Module II
No. ( m2)
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. Area
Section Module I and Module II
No. ( m2)
01 Packing Area 77.9
TOTAL 77.9 m2
Sr. Area
Section Module III
No. ( m2)
02 Bottle washing Area 24.8
04 Bottle Filling and Sealing Area 21.8
TOTAL 92.9 m2
Sr. Area
Section Module III
No. ( 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 NUMBER OF EMPLOYEES
Technical 14
Production-Manufacturing
Non-Technical Skilled -22 & Unskilled-206
Technical 20
Quality Control
Non-Technical 06
Technical 11
Quality Assurance
Non-Technical 01
Technical 09
Warehouse and Distribution
Non-Technical 19
Technical 06
Engineering
Non-Technical 09
Supervisor 01
House Keeping
Labourer 29
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. Reddys 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.
External Testing Laboratory Tel No.
No
01. Bangalore Test House- BTH Phone: 080 23388895
No. 65, 20th main, Marenhalli, Vijayanagar

BANGALORE 560 040 Fax: 080 23385979
02. Shiva Analyticals (India) ltd Phone: 080 5353961

Plot No. 24D (P) and 34D, KIADB Industrial Area
Hoskote 562 114 Fax:
03. Sipra Labs Pvt Ltd. Phone: 040 23734720
Space no. 7, 4th floor, Nilgiri Adidya Enclave
Ameerpet, Hyderabad-560038 Fax:
04. Ashco Analytical Services Phone: 040 3406557
103, Diamond House, 6-3-83/D3/D4
Behind TOPAZ, Panjagutta, Hyderabad 500 082 Fax:
05. A to Z Pharmaceuitcals Pvt. Ltd. Phone: 042-26585811,
No. 12, Balaji Nagar , Ambattur, Chennai-600053 Fax: 26585855
06. Medlar Laboratories Pvt. Ltd Phone: 91-22-25786466,
2nd floor blding no.14, Village Hariyali, Vikhroli(w) 25798330
Mumbai-400083 Fax:
07. Manisha Laboratories Pvt. Ltd Phone: 28699888,28602292,
135-A Govt. Industrial estate . Charkop 28683666
kandivali (W) Mumbai -400067 Fax: 28602297
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Sl.
External Testing Laboratory Tel No.
No
08. Chemi Labs Phone: 040-23073496
Plot No. 121. Opposite Murthy building, Prashanth
Nagar, Kukatpally, Hyderabad-72
09. General Analytical Laboratory Phone: 080-3343376, 3340395
th th
No.16, 17 cross, 13 main road, Malleswaram,
Bangalore-560 055 Fax: 080-3340395
Other services obtained from the external agencies are as follows;
Pest and Rodent Control

1 Pesterad Services Phone: 91-080-26679604
st
F-9, 1 Floor, Basco Court, Gandhi Bazar Fax: 91-080-26614101
Main Road, Bangalore 560 004India Mobile 98455 97918
Calibration of Critical Measuring, recording, weighing instruments.

1. ACVS Phone: 91-080-26530093
Calibration Services of Electrical, Mechanical & Tele-Fax: 91-080-26654488
th
Control Instruments Kyaswar mansion, No.: 180/44, 16 Mobile 9845046294
th
Main, 4 T Block, Jayanagar, Bangalore 560 041.
2. SRP ENVIRO SERVICES PVT. LIMITED Phone: 91-080-22243411
213/60, Ground floor, 11th cross, Wilson Garden, Tele-Fax: 91-080-22243412
Bangalore-560 022.
3. 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
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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5. Jet Inks Private Limited Phone: 91-44-42233200

Old No. 12A, New No.22, Fax: 91-44-28202327
Nungambakkam High Road, Chennai-600 034.
6. SRI BALAJI ENGINEERING SYSTEMS Phone: 91-080-26586647
No. 100, 2nd cross, 3rd Main, Dollars Colony, Mobile: 9844113826
4th phase, J.P. Nagar, Bangalore-560 078.
7. MANIRANJAN DIESEL SALES & SERVICE PVT. Phone: 91-080-42043737
LTD Tele-Fax: 91-080-25203035
#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 Programs
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. Dated:
Responsibilities of the Quality Assurance Department

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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 cGMPs 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
Name Experience Designation
Qualification
M.Sc, Ph.D in
Dr.B.S.Mahadev 26 years Director (Technical & Works)
Microbiology
Mr. Rajesh kapoor B.Pharma 14 years GM Corporate QA & RA
Mr. Promod kumar Jain Ph.D in 35 years GM Corporate QC

Chemistry
Mr. A.T.Rao B.Pharma. 15 years Sr. Manager Production
Mr. Gopal Krishna M.Sc 11 years Sr. Asst manager QA

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SMF/GP/08 SMF/GP/07 APRIL. 2010 PAGE 16 OF 50
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
SOPs and cGMPs, 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 modules 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 Processing and Primary packing areas Corridor / Secondary change room
specifications (AHU- Class D) (Ventilation)
Type Re-circulation
Quality of air Complies to clean room at rest condition
Temperature Between 25C + 2C NMT 30C
Relative
Not more than 75%
humidity
No. of air
Not less than 20 Per hour
changes
Pressure
Corridor is not less than 0.5 mm of WC with respect to adjacent areas.
differential
Filter Filter Efficiency
Configuration
10 (in AHU mixing chamber) 90%
5 (in AHU mixing chamber) 99.5%
0.3 (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 20 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 AHUs 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 5, 1 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 Chlori
Filter nation
WATER FROM
BORE WELL
D.M.PLANT
TOILETS
25,000 LITERS 25,000 LITERS KITCHEN

STORAGE TANK STORAGE TANK
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) Potable/Raw water direct from bore well is tested at the sampling points with the following
frequency:
Sampling Frequency
Details Types of water
Point No. Sampling
S1 Raw water sampling point before Chlorination Potable Water

Monthly Twice
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
b) Purified water sampling points and their testing frequencies are as follows.
Chemical and Microbiological analysis
Sampling Frequency
Details Types of water
Point No. Sampling
S5 After Storage tank Purified Daily
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

Daily One
User Point.
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 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 SPECIFICATIONS

CRITERIA
(i) Total viable aerobic count Not more than 500 As per current BP/IP.
CFU / ml
(ii) Test for specified organism

In-house test additionally tested.
(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.

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2. SPECIFICATIONS OF PURIFIED WATER- IP/BP
TESTS SPECIFICATION
Description A clear, colourless, odourless and tasteless liquid.
Conductivity at 25c NMT 4.3 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.
(ii) Test for specified organism

(a) Escherichia coli. Absent/ml In-house test additionally
tested.
(b) Pseudomonas aeruginosa Absent/ml
(c) Staphylococcus aureus Absent/ml
(d) Salmonella Absent/ml
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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.
SITE MASTER FILE
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.
Equipment details
No.
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.)

Tube filling and sealing machine
16.
(90 to 120 tube per minute)
17. Overprinting machine
18. Ink jet printer
SITE MASTER FILE
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
SITE MASTER FILE
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.
SITE MASTER FILE
C.3.9 Qualification, Validation and Calibration
Companys 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.
SITE MASTER FILE
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.
SITE MASTER FILE
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.
SITE MASTER FILE
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 AHUs 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.
SITE MASTER FILE
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.

SITE MASTER FILE
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.
SITE MASTER FILE
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
SITE MASTER FILE
Flow diagrams of the process- External Preparations (Creams & Lotions)

DISPENSING
PREPARATION OF OIL PHASE AND
PREPARATION OF WATER PHASE

MIXING

BY THE QCD
FILLING
PACKING

RELEASE BY THE QCD
QA RELEASE
DISPATCH
SITE MASTER FILE
Flow diagrams of the process- External Preparation (Toothpaste)

DISPENSING
GUM SOAKING

MIXING

BY THE QCD
FILLING
PACKING

RELEASE BY THE QCD
QA RELEASE
DISPATCH
SITE MASTER FILE
Flow diagrams of the process- External Preparation (Mouthwash)

DISPENSING
PREPARATION OF ACTIVES, INACTIVE, COLOURS

AND FLAVORS

MIXING

BY THE QCD
FILLING

PACKING

RELEASE BY THE QCD
QA RELEASE
DISPATCH
SITE MASTER FILE
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. Suppliers 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.
SITE MASTER FILE
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
SITE MASTER FILE
Raw material and Packaging Material Flow Chart
Raw Material & Checking of Containers Quarantine Goods Receipt

Packaging Material & Documents Area Note Preparation
Under Test
Yellow Label on Sampling by QC
all sampled packs
Printed Packaging Quality Control

Materials Shall be Department
destroyed at the site
Shifted to Rejected Rejected Red Rejected Testing as per

Area Label on all packs Specifications
Approved
Only Raw Green Label Approved
Materials Back to
Supplier only
Shifted To
Approved Area
Raw Material & Packaging

Material Requisition from
Production
Dispensing
Processing
Despatch
SITE MASTER FILE
Finished Product - Flow Chart
Approved Materials
Requisition from Production
Issuance of
Batch Record
Dispensing
Manufacturing As per Controlled Batch

Processing Manufacturing Documents
BMR & BPR
Analytical Report Batch Record

Review (QA) 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
SITE MASTER FILE
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.
SITE MASTER FILE
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.
SITE MASTER FILE
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.
SITE MASTER FILE
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.
SITE MASTER FILE
C.8.3 Product Recalls
Schematic Flow chart of Product Recall
Head Quality & Recall committee
Intimate to contract giver if product Head QA investigate & recommend

belongs to them 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.
SITE MASTER FILE
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 auditees 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 non-
conformance report raised is closed by the auditor after implementation of the action plan.
Quality Assurance Manager maintains.
SITE MASTER FILE
C.10 CHANGE HISTORY
Version Supersedes Changes made

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
i) Effective date NOVEMBER 2009

ii) Inclusion of Updated Organogram
iii) Inclusion of Purified Water Specification & flow
SMF/GP/07 SMF/GP/06 chart
iv) Flow chart of Product Recall and Market
Complaint updated.
v) Updation of Employee strength.
i) Effective date APRIL 2010
ii) Approval & Authorization sheet
iii) Contact persons during outside working hours
iv) Organizational structure of Qualilty Assurance
SMF/GP/08 SMF/GP/07 v) 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 Page 51

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SITE MASTER FILE

DOCUMENT NO. SUPERSEDES DOC. NO. EFFECTIVE FROM PAGE NO.

SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 1 OF 51

SL. No. TITLE PAGE NO.

C.1 GENERAL INFORMATION 3 TO 15

C.3 PREMISES AND EQUIPMENT 18 TO 34

C.6 QUALITY CONTROL 45 TO 46

C.7 CONTRACT MANUFACTURE AND ANALYSIS 47

C.10 CHANGE HISTORY 51

SL. NO. ANNEXURE PARTICULARS

SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 2 OF 51

APPROVAL AND AUTHORIZATION SHEET

Site-Plot No. 41, KIADB Industrial Area,

Malur- Kolar District 563 130 ,

Tel: +91-80-8151-234237; Fax: +91-80-8151-235084

Mr. A.TRIVIKRAM RAO

Dr. PROMOD KUMAR JAIN

Mr. RAJESH KAPOOR Quality

Dr. B.S.MAHADEV Overall In-

SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 3 OF 51

C.1 GENERAL INFORMATION

C.1.2 LICENSABLE ACTIVITIES

C.1.3 OTHER MANUFACTURING ACTIVITIES AT THE SITE

SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 4 OF 51

C.1.4 NAME AND ADDRESS

Group Pharmaceutical Limited

Contact persons during and outside working hours

Name of person Office Phone No. Mobile No.

Mr. Sunil Attavar

Dr. B.S. Mahadev

Mr. Rajesh Kapoor

SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 5 OF 51

C.1.5 TYPE OF PRODUCTS MANUFACTURED AT THE SITE.

LIST OF PRODUCTS MANUFACTURED

C.1.6 DESCRIPTION OF THE SITE

A) Hospital : Manasa Nursing Home Malur 2 km

B) Fire Station : 40 km (Kolar Tamaka)

Total Land Area = 4 acres

SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 6 OF 51

Area of various Modules and Sections

SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 7 OF 51

C.1.7 NUMBER OF EMPLOYEES WORKING IN THE PLANT (Department Wise)

DEPARTMENT CATEGORY NUMBER OF EMPLOYEES

SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 8 OF 51

C.1.8 CONTRACT MANUFACTURE

SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 9 OF 51

C.1.9 USE OF OUTSIDE EXPERTISE

No. 65, 20th main, Marenhalli, Vijayanagar

02. Shiva Analyticals (India) ltd Phone: 080 5353961

SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 10 OF 51

Other services obtained from the external agencies are as follows;

Pest and Rodent Control

Calibration of Critical Measuring, recording, weighing instruments.

SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 11 OF 51

5. Jet Inks Private Limited Phone: 91-44-42233200

SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 12 OF 51

C.1.10 QUALITY MANAGEMENT SYSTEM

satisfaction of the medical profession and the consumers.

We plan to achieve the consistent high quality of products through

Best Available Resources

Well Trained Personnel

Good Manufacturing Practices

Continual Improvement Programs