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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

C.8 DISTRIBUTION, COMPLAINTS AND PRODUCT RECALLS 47 TO 49

C.9 SELF INSPECTION 50

C.10 CHANGE HISTORY 51

SL. NO. ANNEXURE PARTICULARS

01 ANNEXURE – I Photocopy of Manufacturing

Licence

02 ANNEXURE – II List of Equipments &

Instruments

03 ANNEXURE –III

Layouts detailing men/material movement, General Layout and AHU

Classifications,



Email:

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 protected]

Sl. No. ACTIVITY NAME AND DESIGNATION DEPARTMENT SIGNATURE & DATE

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 In-Charge

mailto:[email protected]�


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


SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 4 OF 51 C.1.4 NAME AND ADDRESS

Group Pharmaceutical Limited

Site Address:

Plot No. 41, KIADB Industrial Area, Malur- Kolar District – 563 130 , Karnataka, INDIA

Phone: +91-(0)-8151-234237

Fax: +91-(0)-8151-235084

Web Site: www.grouppharma.in

Registered Office:

W/46 (B) MIDC, Tarapur 401 508

Thane District, INDIA

Phone: +91-0-2525-272108

Fax: +91-0-2525-274036

Administrative Office

Devraj Building ‘A’ wing

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



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.



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)


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)


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



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

DEPARTMENT CATEGORY NUMBER OF EMPLOYEES

Production-Manufacturing Technical 14

Non-Technical Skilled -22 & Unskilled-206

Quality Control Technical 20

Non-Technical 06

Quality Assurance Technical 11

Non-Technical 01

Warehouse and Distribution Technical 09

Non-Technical 19

Engineering Technical 06

Non-Technical 09

House Keeping Supervisor 01

Labourer 29

Administration -- 12

Security -- 12

TOTAL EMPLOYEES Technical 61

Non-Technical 316



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



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 External Testing Laboratory Tel No.

01. Bangalore Test House- BTH

No. 65, 20th main, Marenhalli, Vijayanagar

BANGALORE – 560 040

Phone:

Fax:

080 23388895

080 23385979

02. Shiva Analyticals (India) ltd

Plot No. 24D (P) and 34D, KIADB Industrial Area

Hoskote – 562 114

Phone:

Fax:

080 – 5353961

03. Sipra Labs Pvt Ltd.

Space no. 7, 4th floor, Nilgiri Adidya Enclave

Ameerpet, Hyderabad-560038

Phone:

Fax:

040 – 23734720

04. Ashco Analytical Services

103, Diamond House, 6-3-83/D3/D4

Behind TOPAZ, Panjagutta, Hyderabad – 500 082

Phone:

Fax:

040 – 3406557

05. A to Z Pharmaceuitcals Pvt. Ltd.

No. 12, Balaji Nagar , Ambattur, Chennai-600053

Phone:

Fax:

042-26585811,

26585855

06. Medlar Laboratories Pvt. Ltd

2nd floor blding no.14, Village Hariyali, Vikhroli(w)

Mumbai-400083

Phone:

Fax:

91-22-25786466,

25798330

07. Manisha Laboratories Pvt. Ltd

135-A Govt. Industrial estate . Charkop

kandivali (W) Mumbai -400067

Phone:

Fax:

28699888,28602292,

28683666

28602297



Sl.

No External Testing Laboratory Tel No.

08. Chemi Labs

Plot No. 121. Opposite Murthy building, Prashanth

Nagar, Kukatpally, Hyderabad-72

Phone:

040-23073496

09. General Analytical Laboratory

No.16, 17th cross, 13th main road, Malleswaram,

Bangalore-560 055

Phone:

Fax:

080-3343376, 3340395

080-3340395

Other services obtained from the external agencies are as follows;

Pest and Rodent Control

1 Pesterad Services

F-9, 1st Floor, Basco Court, Gandhi Bazar

Main Road, Bangalore – 560 004India

Phone:

Fax:

Mobile

91-080-26679604

91-080-26614101

98455 97918

Calibration of Critical Measuring, recording, weighing instruments.

1. ACVS

Calibration Services of Electrical, Mechanical &

Control Instruments Kyaswar mansion, No.: 180/44, 16th

Main, 4th T Block, Jayanagar, Bangalore – 560 041.

Phone:

Tele-Fax:

Mobile

91-080-26530093

91-080-26654488

9845046294

2. SRP ENVIRO SERVICES PVT. LIMITED

213/60, Ground floor, 11th cross, Wilson Garden,

Bangalore-560 022.

Phone:

Tele-Fax:

91-080-22243411

91-080-22243412

3. G. SHANKAR RAO

MAHALASA KUTIR

No. 10/19, Ist ‘C’ cross, Near Nandi Enclave Apts.,

5th Main, 5th block, Banashankari 3rd stage,

Bangalore – 560 085.

Phone:

Tele-Fax:

Mobile:

91-080-26693694

91-080-26693693

9845289612

4. ANU POWER SYSTEMS

A/4, 32 cross, 3rd Main, Jayanagar 7th block,

Bangalore-560 082



5. Jet Inks Private Limited

Old No. 12A, New No.22,

Nungambakkam High Road, Chennai-600 034.

Phone:

Fax:

91-44-42233200

91-44-28202327

6. SRI BALAJI ENGINEERING SYSTEMS

No. 100, 2nd cross, 3rd Main, Dollar’s Colony,

4th phase, J.P. Nagar, Bangalore-560 078.

Phone:

Mobile:

91-080-26586647

9844113826

7. MANIRANJAN DIESEL SALES & SERVICE PVT.

LTD

#3032A, 8th Main, HAL 2nd Stage, Indiranagar,

Bangalore-560 038.

Phone:

Tele-Fax:

91-080-42043737

91-080-25203035


SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 12 OF 51 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. Dated:

Responsibilities of the Quality Assurance Department


SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 13 OF 51 • 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


SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 14 OF 51 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


SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 15 OF 51 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

Name Academic

Qualification Experience Designation

Dr.B.S.Mahadev 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

Mr. Gopal Krishna M.Sc 11 years Sr. Asst manager QA


SMF/GP/08 SMF/GP/07 APRIL. 2010 PAGE 16 OF 50 PLANT ORGANOGRAM


SMF/GP/08 SMF/GP/07 APRIL. 2010 PAGE 17 OF 51

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.



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



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.



C.3.3 Brief description of AHU system:

Technical specifications

Processing and Primary packing areas (AHU- Class D)

Corridor / Secondary change room (Ventilation)

Type Re-circulation

Quality of air Complies to clean room at rest condition

Temperature Between 25°C + 2°C NMT 30°C

Relative humidity Not more than 75%

No. of air changes Not less than 20 Per hour

Pressure differential Corridor is not less than 0.5 mm of WC with respect to adjacent areas.

Filter Configuration

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.



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.


SMF/GP/08 SMF/GP/07 APRIL. 2010 PAGE 22 OF 51 Figure 3.9: Raw water system at Group Pharmaceutical Limited WATER FROM BORE WELL

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.

Sand Filter

25,000 LITERS STORAGE TANK

25,000 LITERS STORAGE TANK

D.M.PLANT TOILETS KITCHEN QC

Chlorination



Figure 3.10: Schematic diagram of the de-mineralised water plant


SMF/GP/08 SMF/GP/07 APRIL. 2010 PAGE 24 OF 51 a) Potable/Raw water direct from bore well is tested at the sampling points with the following

frequency:

Sampling Point No. Details Types of water

Frequency 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 Point No.

Details Types of water Frequency Sampling

S5 After Storage tank Purified Daily

S6 User Point -1 : Module II Manufacturing Purified

Daily One

User Point.

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 Weekly Once



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

CFU / ml

As per current BP/IP.

(ii) Test for specified organism

(a) Escherichia coli.

(b) Pseudomonas aeruginosa

(c) Staphylococcus aureus

(d) Salmonella

Absent

Absent

Absent

Absent

In-house test additionally tested.

*NOTE: Current version of the document shall be valid as on date.



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.

(ii) Test for specified organism

(a) Escherichia coli.

(b) Pseudomonas aeruginosa

(c) Staphylococcus aureus

(d) Salmonella

Absent/ml

Absent/ml

Absent/ml

Absent/ml

In-house test additionally tested.


SMF/GP/08 SMF/GP/07 APRIL. 2010 PAGE 27 OF 51 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.



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



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



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.



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.


SMF/GP/08 SMF/GP/07 APRIL. 2010 PAGE 32 OF 51 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.


SMF/GP/08 SMF/GP/07 APRIL. 2010 PAGE 33 OF 51 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”.


SMF/GP/08 SMF/GP/07 APRIL. 2010 PAGE 34 OF 51 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.


SMF/GP/08 SMF/GP/07 APRIL. 2010 PAGE 35 OF 51 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.


SMF/GP/08 SMF/GP/07 APRIL. 2010 PAGE 36 OF 51 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.


SMF/GP/08 SMF/GP/07 APRIL. 2010 PAGE 37 OF 51 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



Flow diagrams of the process- External Preparations (Creams & Lotions)

APPROVED RAW MATERIALS

DISPENSING

PREPARATION OF OIL PHASE AND

PREPARATION OF WATER PHASE


MIXING


FILLING



PACKING


QA RELEASE

DISPATCH



Flow diagrams of the process- External Preparation (Toothpaste)


GUM SOAKING


MIXING


FILLING



PACKING


QA RELEASE

DISPATCH



Flow diagrams of the process- External Preparation (Mouthwash)


PREPARATION OF ACTIVES, INACTIVE, COLOURS AND FLAVORS


MIXING


FILLING


PACKING MATERIAL ISSUANCE PACKING


QA RELEASE

DISPATCH



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.



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



Raw material and Packaging Material Flow Chart

Raw Material & Packaging Material

Checking of Containers & Documents

“Quarantine” Area

Goods Receipt Note Preparation

Sampling by QC “Under Test” Yellow Label on all sampled packs

Quality Control Department

Testing as per Specifications

“Rejected” Red Label on all packs

Approved

Shifted To Approved Area

Raw Material & Packaging Material Requisition from Production

Dispensing

Processing

Despatch

“Approved” Green Label

Shifted to Rejected Area

Printed Packaging Materials Shall be destroyed at the site

Only Raw Materials Back to Supplier only

Rejected



Finished Product - Flow Chart

Issuance of Batch Record

• BMR: Batch Manufacturing Record

• BPR: Batch Packing Record

Approved Materials

Dispensing

Manufacturing Processing

Analytical Report Review (QA)

Batch Record Review (QA)

Authorization for Release by Quality Assurance

Transfer to Finished Goods Store

Despatch

In-Process Checks

As per Controlled Batch Manufacturing Documents

• BMR & BPR

Requisition from Production


SMF/GP/08 SMF/GP/07 APRIL. 2010 PAGE 45 OF 51 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.


SMF/GP/08 SMF/GP/07 APRIL. 2010 PAGE 46 OF 51 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.



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.



C.8.2 Handling of Complaints

Schematic Flow chart of handling Market Complaints

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.

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



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.



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 non-

conformance report raised is closed by the auditor after implementation of the action plan.

Quality Assurance Manager maintains.



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

SMF/GP/07 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/08 SMF/GP/07

i) Effective date APRIL 2010 ii) Approval & Authorization sheet iii) Contact persons during outside working hours iv) Organizational structure of Qualilty Assurance

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