SITE MASTER FILE - Nuclear Sciences and Applications - · PDF fileBrief description of water system including sanitation. ... Evaluating and approval of all validation protocols. ...

Neptune Life Sciences

SITE

MASTER

FILE

NEPTUNE LIFE SCIENCES PVT.LTD. PLOT NO. 100 –B,EPIP,PHASE – II , THANA,BADDI (H.P.)

PHONE NO. – 09218480100


SITE MASTER FILE

CHAPTER INDEX PAGE

1

GENERAL INFROMATION

1

1.1

1.2

1.3

1.4

1.5

1.6

1.7

1.8

1.9

Brief Information of the firm.

Pharmaceutical formulations manufacturing activities as

licenced by the state drug authority.

Name and exact address of the site.

Any other manufacturing activity carried out on the site.

Type of products manufactured on the site and any

information about any specifically toxic or hazardous

substances handled.

Short description of the site.

Number of employees.

Use of outside scientific / analytical / other technical

assistance in relation to manufacturing / analysis.

Short description of the quality management system.

1

2

2

2

3

3

4

5

5

2. PERSONNEL 9

2.1

2.2

2.3

2.4

Organization chart showing the arrangements for Quality

Assurance, Including Production and Quality Control.

Outline of arrangements for basic and in service training

and how records are maintained.

Health requirements for personnel engaged in production.

Personnel Hygiene Requirements Including Clothing

9

9

9

10

3. PREMISES & EQUIPMENTS 17

3.1

3.2

3.3

Description of manufacturing area.

Nature of construction and finishes.

Brief description of ventilation systems.

17

17

18


SITE MASTER FILE

CHAPTER INDEX PAGE

3.4

3.5

3.6

3.7

3.8

3.9

3.10

Special area for handling of highly toxic hazardous and

sensitizing materials.

Brief description of water system including sanitation.

Preventive maintenance program for premises.

Equipments.

Maintenance (description of planned preventive

maintenance programmes and recording systems).

Qualifications and calibration including recording system

arrangement for computerized system validation.

The viability of written specifications & procedures for

cleaning manufacturing areas and equipment.

19

19

20

20

20

21

21

4. DOCUMENTATION 22

4.1

4.2

Arrangements for the preparation, revision and distribution

of necessary documentation for manufacturing.

Any other documentation related to product quality which

is not mentioned elsewhere.

(E.g. microbiological control on air and water).

22

23

5. PRODUCTION 24

5.1

5.2

5.3

5.4

Brief description of productional operation using,

wherever possible, flow sheets and charts specifying the

parameters.

Arrangements for handling of starting materials, packing

materials, bulk and finished products, including sampling,

quarantining, releasing and storage of those.

Arrangements for handling of rejected materials and

products.

Brief description of General policy for process validation.

24

25

26

26


SITE MASTER FILE

CHAPTER INDEX PAGE

6

QUALITY CONTROL

27

6.1

6.2

6.3

Description of the Quality Control System and the

activities of the Quality Control Department.

Process for the release of printed components and finished

goods.

Procedure for release of Finished Goods.

Procedure for release of printed packaging material.

27

27

28

7.

DISTRIBUTION, COMPLAINTS & PRODUCT

RECALL

29

7.1

7.2

Arrangements and recording system for distribution.

Arrangements for handling of complaints and product

recall.

29

30

8.

SELF INSPECTION

31

8.1

Short description of the Self Inspection System.

31

9. LIST OF MACHINARY OF BETA – LACTUM CAP.

& TAB, NON-BETA – LACTUM TAB. & CAP. AND

OINTMENT SECTION.

32


SITE MASTER FILE APPROVALS NAME SIGN

REVISION NO. 00 Production Manager Rohit Mittal

EFFECTIVE DATE MAR07 Q. C. Manager Ashok Kumar

PAGE NO. 1 of 39 Director Technical Ravinder Singh

CHAPTER 1

GENERAL INFORMATION

1.1 Brief Information of the Firm (including name & address), relation to

other sites particularly, any information relevant to understand the

manufacturing operations.

The Firm has established a modern facility as per GMP (Schedule M)

standards to manufacture Tablet, Capsule, Dry Syrup ,Ointment and dry

powder injection sections. The unit is managed by experienced technical

staff for production & quality control along with a team of expert

technicians.

The company has a Pharmaceuticals Formulation Plant located on a

9000 sq.Ft. plot situated at Ward No. 10, Paonta Sahib. The facilities include

Raw and Packing materials warehouses, Finished Goods warehouses and

sections for the manufacture of Tablets (Beta-Lactum & Non Beta-Lactum),

Capsules (Beta-Lactum & Non Beta-Lactum), Dry-Syrup , Ointmentsand

dry powder injection All the testing of Raw, Intermediate and Finished

Goods are done in our own well-equipped laboratory. It has a full-fledged

utilities section.






The factory is situated in an open space. No factory producing obnoxious odor

pollutants is adjacent to the factory.

1.2 Pharmaceutical formulations manufacturing activities to be licensed by

the STATE DRUG AUTHORITY.

Has to be licensed by the Drug Controller, to manufacture formulations for

Tablet, Capsule , Ointment and Dry powder injection Section vide

Manufacturing License No.—(Applied for) Commercial production will

start after getting the licence.

1.3 Name and exact address of the site: NEPTUNE LIFE SCIENCES PVT LTD 100-B EPIP PHASE-II THANA BADDI (H.P) PHONE NO. 09218480100

1.4 Any other activities carried out on the site

No other manufacturing activity of any type is carried out in the plant

premises. The plant is solely dedicated in the manufacturing of products for

which it is to be licensed to manufacture.






1.5 Type of actual products manufactured on the site and such information

about especially toxic and hazardous substances handled, mentioning

the way they are manufactured.

The Plant is engaged in the manufacturing of Tablets, Capsules & Dry Syrup

(Beta-Lactum & Non Beta-Lactum) ,Ointments and Dry Powder Injection.

1.6 Short description of the site

Plant Layout: Refer Annexure I

Plot Size: 9000 square Ft.

The site covers 11197.43 square Ft. and is located in the Central Excise

Free Zone, Himachal Pradesh (India). The site has facilities for the

production of Tablets (Beta-Lactum & Non Beta-Lactum), Capsules (Beta-

Lactum & Non Beta-Lactum), Dry Syrup ,Ointments and Dry Powder

Injection.

The common warehouse for Packing Material is located on the first floor of

the site and for dry powder injection’s warehouse on ground floor.

The Raw Material stores for Non Beta-Lactum are located on the first floor

of the site and for Beta-Lactum are located on thethird floor of the site and

for dry powder injection on ground floor.



REVISION NO. 00 Production Manager Rohit mittal



Adequate and separate AHU have been provided for: Tablet and capsule and

ointment (Non Beta-Lactum) tablet Capsules (Beta-Lactum) & Dry powder

injection (Beta-Lactum) .

The site has a centralized utilities section with Generators, Compressed air

system and A. C. system. The R.O. with mixed bed for demineralization

water and multicolumn plant for water for injection located on roof of the

building.

1.7 Number of employees engaged in production, quality control, storage

and distribution.

1. The Plant is headed by the Production Director. The breakup of the

Processing personnel by department is as follows:

Production:

Quality Assurance:

Quality Control:

Materials:

Engineering:

Accounts:

Personnel and Administration:

A total of Thirty-five (35) employees are proposed to work in the

Formulation Unit.






1.8 Use of outside scientific, analytical or other technical assistance in

relation to manufacture and analysis.

Very few analytical instruments are not available with the firm for which

assistance of following reputed and competent laboratories are taken, which

does not infringe legal provision.

1. SAMED LABORATIORIES LTD.

SCF – 340, IIND

FLOOR, MANSA DEVI ROAD,

CHANDIGARH

Ph: - 0172 - 2732949

0172 - 2591661

2. CHOKSI LABORATORIES PVT. LTD.

MANIMAZARA, CHANDIGARH

1.9 Short description of the quality management system

Total Quality Management is achieved by

-Confirming to Schedule M of Drugs & Cosmetics Standards

-All the job functions of the company are in time with its Quality policy. Total

Quality Management of the firm is looked after by a Quality Assurance

Executive. All department heads, up to the Managers, maintain and follow

Quality Management System.






The Quality Management Assurance with the help of other personnel has the

responsibility to see that all procedures are as per the standard operating

procedures. Personnel competence is also assessed by the Quality Assurance

Executive. The total Quality Management System is designed for ‘Zero

Defect Product’ for which the Quality Assurance Executive is responsible.

-All evaluation of procedures and validations are done by the Quality

Assurance Department.

-The factory is having its own fully equipped laboratory with almost all the

In-House testing facilities of the products being manufactured.

-It is also having adequate, competent Technical Staff to carry out the

Manufacturing Operations Analysis.

The Quality Assurance Department is responsible for:

Preparing, issuing and updating Quality Assurance Policy. Maintaining and

controlling all documentation related to technology transfer.

Audit operation to asses adequacy of QA systems.






Monitoring key quality indicators. The Quality Assurance Manager assigned to

each manufacturing division is responsible for:

Evaluating and approval of all validation protocols.

Assigning AQLs to raw and packaging materials and approve final

specifications.

Specifying sampling procedures.

Evaluation and approval of all final SOPs. Review and approval of all BPRs

prior to release of goods for distribution to ensure compliance to GMPs during

the manufacturing of any batch.

Audit and approval of vendors and contract manufacturers. Evaluating and

analyzing market complaints and batch recalls. Routine finished product

stability.

The Quality Assurance Manager is assisted by In-process Quality Assurance

Officer and Quality Control Executives. The Quality Control Executive is

responsible for testing of all raw and packaging materials, and finished

products.






Specifications and Standard Test Procedures (STPs)

Specifications and STPs are prepared by QC and finally reviewed and issued

by Quality Assurance. In case of regulatory specifications and STPs,

Department of Regulatory Affairs are consulted. Specifications and STPs are

written in prescribed format with identification no., effective date and

approval signatures. These are updated on any change in regulatory

requirements or pharmacopoeias or change in specifications and STPs

Department of Regulatory Affairs are consulted.

Self Inspection & Quality Audits Self-Inspection and Quality Audit is carried out with the objective to detect

any shortcomings in the implementation of GMPs and recommending the

necessary corrective actions. There is a team of Quality Assurance Manager,

Production Manager, Engineering Manager and concerned departmental

head for self-inspection. Such inspections are carried out as per defined

procedure.

Vendor Development

All starting material is procured from approved vendors. In case of a new

supplier, audit of the site is undertaken by the Quality Assurance manager

and Materials manager and both technical and commercial strengths of the

supplier are judged using standard checklist. Apart from this, there is a

system for routine audits / assessment of existing suppliers on continuous

basis.

Similar practice is followed for suppliers of printed packing materials.






CHAPTER – II

PERSONNEL

2.1 Organizational Chart showing arrangement of for Quality Assurance,

including production and quality control.

See attached sheets

2.2 Outline of arrangements for basic and in service training for record

maintenance. The company has structured a training program, which covers the entire

employee. The managers are exposed to different are any programmes as per

need assessed by divisional had. This activity is co-ordinated by cooperate

trainings cell under the personnel manager.

Induction Programme

Personnel Hygiene & Sanitation

Manufacturing Techniques

Operation of Equipment

Cleaning Procedures

GMP Requirements






Safety

Personnel Manager maintains all training records. The records include

personnel names, topics covered, venue and dates of training. An evaluation

of the effectiveness of the training is done and records are maintained.

2.3 Health Requirements for Personnel Engaged in Production

Personnel which come into direct contact in the production activities are

medically examined at the time of recruitment and thereafter annually or as

situation demands from a competent medical practitioner.

Only those persons meeting health standards and are medically fit are

employed. Personnel suffering from any contagious or obnoxious diseases

are not allowed to work or visit the production area.

2.4 Personnel Hygiene Requirements Including Clothing All persons are instructed to observe good personal hygienic practices and

work under good sanitary conditions, such as taking bath daily, keeping

short nails and hair, clean shaven, wearing minimum jewelers and cosmetics

in case of women employees etc.

They are also instructed to wash their hands, legs and face, while reporting

for work / entering production area after wearing factory uniform and

footwear’s, wash their hands thoroughly using soap also after visiting toilets.

They are also trained and instructed to observe good personal habits in

working area such as avoiding smoking, pan / tobacco, chewing, spitting and

alcoholism etc.






CHAPTER – III

PREMISES AND EQUIPMENT

3.1 Description of Manufacturing Area.

Plan for manufacturing area is enclosed herewith

3.2 Nature of constructions and finishes.

The building is constructed with good quality construction materials

resistant to almost all sorts of wear & tear and free from any major flaws

and planned to facilitate unidirectional flow of materials. The walls are

constructed of bricks, plastered to provide a hard smooth finish and

painted. All floor and sealing joints are coved to avoid any sharp edges

thereby eliminating dust accumulation. The floor is concrete with Kota

stone and Mosaque finish flooring. The Ceiling is concrete, plastered with

epoxy falls sealing with Hylex Sheets. The main plant building consists of

ground , first ,second and third floor. The ground floor is having Dry

powder injection section and Q.C.laboratory and Microbiology lab,On first

floor central ware house for raw material and packing material,change

rooms and ointment section (Non Beta-Lactum).On second floor tablet and

capsule ( non-beta lactum) section.On third floor tablet and capsule and

dry syrup(beta lactum) have been provided and on the half portion of the

roof R.O.system and multicolumn distillation system.



REVISION NO. 00 Production Manager Rohit Mittal EFFECTIVE DATE MAR07 Q. C. Manager Ashok Kumar


3.3 Brief description of ventilation systems:

Appropriate ventilation arrangements are provided in the factory. Provisions of

windows exhaust fans & ceiling fans are provided in all areas except

manufacturing, filling & sealing rooms. In critical operational area centralized air

conditioning plant is provided. A total number of Sixteen independent Air Handling Units (AHU) have

been provided in the facility: 1. Tablet Section (Non Beta-lactum)

2. Non Beta-lactum Capsules

3. Beta-lactum Tablet

4. Beta –lactum Capsules & dry syrup

5. Ointment Section

6. Blister packing

7. Strip packing

8. Alu- Alu packing (Machine is to be provided . )

9. Microbiology testing Lab including three air locks.

10. Separate A.H.U. have been provided for sterile & non sterile area of dry

powder Injection .

a) Non sterile area – Vial & rubber bung washing room

b) Vial Labeling & packing area

c) Sterile area – Dispensing area, blending area, buffer zone, vial filling

& sealing area,change room & air locks.

Each process operation has it own air-handling system and has temperature & humidity

controls. The corridors are also environmentally controlled and are at positive pressure

as compared to the individual rooms to prevent any mixing of air / powder from each

room to the corridors. Pressure balancing of each air handling system has been done to

avoid any cross contamination.

Each Core Process Room is supplied with controlled air passed through pre-filters

having efficiency of 99% down to 5 µ followed by micron filters having efficiency of

99% down to 3 µ and finally through H.E.P.A. filters having efficiency of 99.97%

down to 0.3 µ. Separate return air ducts are provided in each room at a height of above

100 mm from the floor and are fitted with 10 µ filters at return point. Efficiency of 0.3

µ H.E.P.A. filters are determined by checking the velocity, pressure gradient of

individual areas and based on the result, decision for filter changing is taken. Any

major change in the design of air handling system calls for revalidations. The

individual process area is designed to have a temperature varying from 210

C to 250 C

are maintained. The corridors are kept at positive pressure with respect to the process

cubicles 10% of fresh air taken in each re-circulation cycle of returned air.

The AHU’s are designed to have air changes varying from 20 to 40 per hour depending

upon the process requirement.





All environmental parameters like Particle monitoring, HEPA filter integrity

testing, Air change rates, Air pressure differentials, Temperature, Humidity

and Microbiological Monitoring are checked at periodic intervals.

3.4 Special areas for the handling of highly toxic, hazardous & sensitizing

materials.

No toxic or hazardous and sensitizing materials are handled in this facility.

3.5 Brief description of water system. Please see attached block diagram.

Source of Raw Water: There is municipal water and our bore water as

source of raw water.

The raw water is stored in a tank having capacity of 6,000 Liters. The water

from this tank is passed through R.O. with mixed bed Plant. The DM water

is monitored continuously for its conductivity and pH. This DM water is

pumped up in stainless steel (S.S.) storage tanks of 1000 Lts Capacity. From

there it is distributed to manufacturing area by S.S. pipelines. The tanks are

regularly cleaned & the record of cleaning is maintained.

The D. M water is used for preparing of paste for tablets and for ointments.

D.M.water is pumped to multi column distillation unit to produse water for

injection . This water for injection is distributed to sterile & non sterile area

of powder injection section for cleaning of vials rubber bungs extra.





3.6 Preventive Maintenance Program for Premises

Each weekend the maintenance incharge along with the Quality Assurance

Executive and respective departmental heads, visit each part of the factory to

locate and rectify areas which may require maintenance e.g. cracks /

breakage in structures/plastering, painting etc.

3.7 Equipments

The major equipments are supplied by reputed manufactures in their field.

These are constructed as per internationally norms with the best materials

available (GMP Models). A list of major Production, Quality Control

equipment and utilities with their manufacturers is enclosed in Annexure

VII.

3.8 Maintenance (description of planned preventive maintenance programme

and recording systems).

Preventive maintenance of all equipment is carried out as per the current

SOP. These procedures give details of periodicity of preventive

maintenance, methods of preventive maintenance and special and checks /

replacements to be done. The Maintenance Engineer and Production

Executive are responsible for preventive maintenance of each equipment. An

annual preventive maintenance schedule is drawn up by the Engineering

Manager for all equipment. Engineering Manager checks machines due for

maintenance. Details of such maintenance are recorded in the Equipment

Log Sheet and Equipment History Card.





PAGE NO. 21 of 39 Director Technical Ravinder Singh 3.9 Qualification and calibration including recording system arrangements for

computerized system validation.

Each equipment / system / facility is validated prior to use. Validation includes

installation Qualification (IQ), Operational Qualification (OQ) and Performance

Qualification / Process Qualification (PQ). A team consisting of representatives

from production, QA and Engineering Departments, does IQ OQ & PQ.

The protocols for IQ and OQ check compliance of installed equipment to the

design parameters and fabrication and manufacturing specifications mentioned in

the purchase order or contract. These also ensure inspection of physical installation

to ensure they comply with Engineering Standards and GMPs. Various parameters

to be checked and listed out and criteria; necessary corrective actions are taken by

the agency installing the equipment. Revalidation of equipment is done when it is

replaced by new equipment or major changes in the equipment are introduced.

3.10 Availability of written specifications & procedures for cleaning

manufacturing areas and equipment.

Written procedures for cleaning of manufacturing areas and every equipment are

available. Every equipment used in manufacturing operations is cleaned at the end

of shift as per respective SOP’s. During product changeover the machine parts are

dismantled, washed with water, dried and covered with lint free covers. The

production Executive inspects the equipment and signs on the “Clean Equipment”

tag. In case of product changeover, the last rinse water is analysed by Q.C. Dept. to

ensure that the parts are free from traces of previous product. Prior to start up of

any equipment, the In –Process Quality Assurance Executive certifies that the

equipment is clean and may be used. This certification becomes the part of the

BPR. All areas are cleaned daily as per respective SOP’s, which define the

disinfecting agent and concentration to be used. At the end of any batch the return

air filters are also vacuum cleaned. The In-process Q.A. Inspector prior to start up

of the next batch certifies the area. It is recorded in the BPR.





CHAPTER – IV

DOCUMENTATION

4.1 Arrangements for the preparation, revision and distribution of

necessary documentation of manufacture.

The Q.A. Department prepares, issues and updates the Q.A. Policy. The Q.A.

Department is responsible for preparing, revision and distribution of all documents

for manufacture. All master documents are stored in Central Record Room in Q.A.

Dept. and documentation control as per respective SOP. Every master document

has a review period and it is reviewed mandatory on or before that date.

Circulation of these documents is restricted to authorized users and to be controlled

by issuing department. On changes, documents are rewritten, duly checked,

authorized and signed by two independent persons. All superceded copies of the

document are destroyed, except one copy, which is kept for reference purpose and

is prominently marked as “Superceded”.

It is the responsibility of the Q.A. Dept. to maintain and control documentation

related to specifications of products / processes, raw materials and packaging

components and subsequently, products / material are approved against these

specifications. Documented SOP on sampling of raw materials, packaging

materials, intermediates / finished products are available with the Q.A. Dept.

Approval, issuance and with drawl of SOP is controlled by the Q.A. Dept. and is as

per respective SOP.





Master Formulation / Packaging order as prepared by the R & D need approval of

production and Q.A. Dept. before they are put in use. Similarly, R&D approves

Manufacturing Instructions for process and packing. The Q.A. Dept. reviews and

approves all BPR’s. These BPR’s are maintained with the Q.A. Dept. for a period of

one year after the expiry of the batch. Storage, retrieval, review and destruction of

BPR’s are controlled as per respective SOP.

Validation protocol and results of validation studies for equipment, process and

systems are available with the Q.A. Dept.

Documentation related to equipment specifications form part of respective validation

studies specifications for disposables i.e. cleaning reagents are available. Documents

pertaining to training are available as per respective SOP.

Reconciliation of raw materials, bulk products and packing material forms part of the

BPR.

A Change Control Procedure controls any changes in manufacturing procedures,

change in vendor, equipment etc. and this has to be approved by the Q.A. Manager.

4.2 Any other documentation related to product quality which is not mentioned

elsewhere (e.g. microbiological control on air and water).

A routine monitoring of water (potable and purified water) is done drawing samples

from various points of usage. The plan envisages that purified water from every

usage point is checked once every week for microbiological and chemical tests.

Potable water is tested microbiologically once in three months.






CHAPTER – V

PRODUCTION

5.1 Brief description of production operation using, wherever possible, flow

sheets and charts specifying parameters.

Please see attached flow charts.

The Production Planning Department issues a computerized batch production

record (BPR) for manufacturing a batch. The BPR consists of a Formulation Order

and a Packaging Order. The formulation order is as per the Master Formula, issued

by Formulation Development Laboratory and which has been fed into the

computer. Access to update this Master Formula on the computer is restricted only

to concerned Formulation Department Manager.

Based on the bill of materials, the computer assigns particular quantities of raw

material (active & inactive) for that particular batch on FIFO basis. The dispensing

of the material required for the particular batch against the particular Quality

Control Analytical Reference No. Mentioned in the Formulation Order is done by a

technician in presence of a warehouse supervisor.

The batch is then fabricated / manufactured as per the manufacturing instructions

given in the BMR. Every operation requires a ‘doer’ and ‘checker’ signature. In-

process checks are carried out at predetermined time intervals by both, production

and in-process Quality Assurance Executives and recorded in the BMR.





Quality Control Laboratory checks samples of intermediates and finished goods. In

case the batch meets the specifications, the Quality Assurance Manager reviews the

complete batch manufacturing record to ensure compliance with GMPs during the

manufacturing. The Quality Assurance Manager then releases the batch for

distribution.

5.2 Arrangement for handling of starting material, packing material, bulk

and finished products, including sampling, quarantine, release and

storage.

Please see attached flow charts.

All raw and packaging materials are received at the warehouse. On receipt of the

material, the warehouse officer checks the supplier’s documents accompanying the

goods. The warehouse personnel feed the details of these goods in the record book

and under test label pasted on the material containers. The No. Of labels are equal to

the No. Of containers received. The goods are stored in a separate “Under Test Area”

Q.C. Executive draws a representative sample of the batch. Sampled labels are

attached to each container taken for sampling. Sampling of raw materials, packing

materials and intermediate are done as per the respective SOPs.

The Q.C. lab against approved specifications tests a pooled sample in case the

material is approved, the data is feed in the computer as approval and the warehouse

is informed. The Q.C. officer affixes “Approved” sticker on each and every container

and the material are moved to the “Approved Bay”. In case of rejection the Q.C.

officer affixes “Rejected” sticker on the containers and they are moved to “Rejected

Bay”.





All material is stored in warehouse as per the storage conditions prescribed by the

manufacturer. Dispensing of the material in warehouse is done as per BPR issued by

Production Planning Department and materials are transferred to Production Block.

At intermediate stages during manufacturing IP Q.A. draw random samples from

each batch and send these for testing in Q.C. Labs. Finished Goods after “

Release ” are taken for distribution.

5.3 Arrangement for handling of rejected materials and products.

Any raw or packaging material that does not confirm to the approved specifications

is treated as rejected material. On completion of the testing, the Q.C. Dept. affixes

“Rejected” Label on each such container and a Rejection Note is prepared by giving

reasons for Rejection.

The stocks are moved to an area designated for rejected stock. The Purchase Dept.

informs the vendor on the rejection along with the reasons for rejection. The rejected

stocks are then sent back to the vendor. In case of rejection of labels, Cartons the

respective materials are destroyed in presence of the representatives from purchase

warehouse, Q.C. Dept. and Security Controls. In case a batch does not confirm to

specification, then the Q.A. Manager in consultation with process development takes

decision on destruction or reprocessing.

5.4 Brief description of General policy for process validation.

As a policy of a company, all the processes are validated before the start of

commercial production, any changes in a validated process have to be revalidate

prior to switch over basis controlled through SOP.

A process is considered to be validated when three consecutive batches give results

within the specified limits. Validation is carried out by a team consisting of

managers from production and Q.A.






CHAPTER – VI

QUALITY CONTROL

6.1 Description of the Quality Control System and of the activities of the

Quality Control Department. Process for the release of printed

components and finished goods. The Quality Control Department is part of the Quality Assurance Department. It is

headed by a Quality Control Manager. The major activities of the Quality Control

Department are:

1. Approve / Rejection of raw and packaging materials as per respective SOP.

2. Testing of in-process samples as per respective SOP.

3. Testing of finished goods as per respective SOP.

4. Carrying out stability studies as per respective SOP.

5. Testing of water as per respective SOP.

6.2 Procedure for release of Finished Goods. As soon as any batch has been finally packed, the in-process Q.A. Personal draws

random samples of the finished goods. These random samples are tested against

approved specifications by the Q.C. Dept. These specifications are normally more

stringent that the Pharmacopoeial requirements. If the random samples meet the

specifications (known as Product Release Specifications), the Quality Control

Department certifies that the goods meet the laid down specifications.






The batch Production Record is then reviewed by the Quality Assurance Manager.

He checks for the completeness of the documents and for the compliance with GMP

at various steps. The QA Manager ‘Releases’ the batch for distribution by signing

the BPR.

6.3 Procedure for release of printed packaging material.

All printed packaging materials on receipt from vendor are stored in warehouse with

‘Under Test’ status. A Goods Receipt Note for the material is made and sent to Q.C.

Dept. The Q.C. Dept. assigns an Analytical Reference Number to the material and

does sampling of the same as per respective SOP of sampling. Samples are tested as

per the approved specifications and compared with approved standards and shade

cards, following Standard Test Procedures. If the samples conform to the

specifications, then the consignment is released and an “Approved” label is pasted

over the “Under Test” label. The consignment is then moved to the ‘Approved Bay’.





CHAPTER – VII

DISTRIBUTION, COMPLAINTS & PRODUCT RECALL

7.1 Arrangements and recording system for distribution. The ‘Released’ finished goods are transferred from Production Block to the

finished goods warehouse through a ‘Finished Goods Transfer Note’, duly

approved by Q.A. Dept. The stocks are fed into the computer and the inventories

get updated. Finished products, which require air-conditioning, are stored in

air-conditioning area.

The distribution of finished goods is done on FIFO basis.

In case of domestic market, the distribution department gives details of stocks to

be transferred to various branches all over India. The stocks to be transferred to

various branches and details of these transactions are updated in the computer.

The various branches then invoice stocks to various wholesalers and records of

these transactions are maintained at respective branches.






7.2 Arrangements for handling of complaints and product recall.

Any market complaint is handled as per respective SOP. A copy of the SOP is

attached herewith.

In case of product recall, the Q.A. Manager informs the Head of Marketing

through telephone, telex or fax. This is followed by a written communication

by the QAM to the Head of Marketing. The Head of Marketing then informs

through telephone, telex or fax followed by a written communication to all

Regional Managers to quarantine all stocks and withdraw the batch from the

wholesaler / retailer.

The Distribution Manager reconciles the total quantities of the batch against the

quarantined batch and sends the stock back to the manufacturing location with

‘Quarantine’ marked on each shipper.

The stocks are stored in Quarantined Area at the manufacturing location till all

investigation is completed by Q.A. Manager.

The Regulatory Authorities are informed about the batch recall and its

reconciliation. Further action is taken depending upon the reasons for recall.

Details of these are mentioned in as per respective SOP.






CHAPTER – VIII

SELF-INSPECTION 8.1 Short description of the Self Inspection System.

The Company has a defined Self Inspection System through which all

manufacturing functions, Engineering Department, Quality Control Department

and warehouse are audited by a team of Managers consisting of Works

Manager, Q.A. Manager and Production Manager and the Department Head of

Department being audited. The audit is carried out as per the SOP. All

deficiencies noted in the inspection are attended to by the Departmental Head

and a report issued by him.
