Site Master File: Therapeia Biologics

Therapeia Biologics
SITE
MASTER
FILE
Therapeia Biologics,
Building no. 14, 212/2, Off Soli Poonawalla Road, Navi Mumbai,
Mumbai -400614
Tel: 022-26602113, 26602378, 26602978
FAX: 022-26993945, 26993921
Email: Therapeiabio.com
Therapeia Biologics
SITE MASTER FILE
CHAPTER INDEX PAGE
1 GENERAL INFROMATION 1
1.1 Brief Information of the firm. 1

1.2 Pharmaceutical formulations manufacturing activities as
licenced by the state drug authority. 2
1.3 Name and exact address of the site.
1.4 Any other manufacturing activity carried out on the site. 2
1.5 Type of products manufactured on the site and any 2
information about any specifically toxic or hazardous 3
substances handled.
1.6 Short description of the site.
1.7 Number of employees. 3
1.8 Use of outside scientific / analytical / other technical 4
assistance in relation to manufacturing / analysis. 5
1.9 Short description of the quality management system.
5
2. PERSONNEL 9
2.1 Organization chart showing the arrangements for Quality 9

Assurance, Including Production and Quality Control.
2.2 Outline of arrangements for basic and in service training 9
and how records are maintained.
2.3 Health requirements for personnel engaged in production. 9
2.4 Personnel Hygiene Requirements Including Clothing 10
3. PREMISES & EQUIPMENTS 17
3.1 Description of manufacturing area. 17

3.2 Nature of construction and finishes. 17
3.3 Brief description of ventilation systems. 18
Therapeia Biologics
SITE MASTER FILE
CHAPTER INDEX PAGE
3.4 Special area for handling of highly toxic hazardous and 19

sensitizing materials.
3.5 Brief description of water system including sanitation. 19
3.6 Preventive maintenance program for premises. 20
3.7 Equipments. 20
3.8 Maintenance (description of planned preventive 20
maintenance programmes and recording systems).
3.9 Qualifications and calibration including recording system 21
arrangement for computerized system validation.
3.10 The viability of written specifications & procedures for 21
cleaning manufacturing areas and equipment.
4. DOCUMENTATION 22
4.1 Arrangements for the preparation, revision and distribution 22

of necessary documentation for manufacturing.
4.2 Any other documentation related to product quality which 23
is not mentioned elsewhere.
(E.g. microbiological control on air and water).
5. PRODUCTION 24
5.1 Brief description of productional operation using, 24

wherever possible, flow sheets and charts specifying the
parameters.
5.2 Arrangements for handling of starting materials, packing 25
materials, bulk and finished products, including sampling,
quarantining, releasing and storage of those.
5.3 Arrangements for handling of rejected materials and 26
products.
5.4 Brief description of General policy for process validation. 26
Therapeia Biologics
SITE MASTER FILE
CHAPTER INDEX PAGE
6 QUALITY CONTROL 27
6.1 Description of the Quality Control System and the 27

activities of the Quality Control Department.
Process for the release of printed components and finished
goods.
6.2 Procedure for release of Finished Goods. 27
6.3 Procedure for release of printed packaging material. 28
7. DISTRIBUTION, COMPLAINTS & PRODUCT 29

RECALL
7.1 Arrangements and recording system for distribution. 29

7.2 Arrangements for handling of complaints and product 30
recall.
31
8. SELF INSPECTION
8.1 Short description of the Self Inspection System. 31
9. LIST OF MACHINARY OF BETA – LACTUM CAP. 32

& TAB, NON-BETA – LACTUM TAB. & CAP. AND
OINTMENT SECTION.
Therapeia Biologics
SITE MASTER FILE APPROVALS NAME SIGN

REVISION NO. 00 Production Manager Sudipto Biswas
EFFECTIVE DATE MAR07 Q. C. Manager Deepti Bhat
PAGE NO. 1 of 39 Director Technical Amir Huzer
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 Vaccine, Tablet, Capsule, Dry Syrup ,Ointment and
drypowder 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.
Therapeia Biologics

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:

Therapia Biologics, Building no. 14, 212/2, Off Soli Poonawalla Sector-11, Navi
Mumbai, Mumbai-400614
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.
Therapeia Biologics

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 recombinant Hepatitis B

vaccine.
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.
Therapeia Biologics

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.
Therapeia Biologics

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.
Therapeia Biologics

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.

Therapeia Biologics

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.
Therapeia Biologics

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 asystem
for routine audits / assessment of existing suppliers on continuous basis.
Similar practice is followed for suppliers of printed packing materials.
Therapeia Biologics

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
Therapeia Biologics

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.
Therapeia Biologics

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,changerooms
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.
Therapeia Biologics

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 21 0 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.
Therapeia Biologics

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 areaof
powder injection section for cleaning of vials rubber bungs extra.
Therapeia Biologics

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.
Therapeia Biologics

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 cleaningmanufacturing

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.
Therapeia Biologics

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.
Therapeia Biologics

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.
Therapeia Biologics

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.
Therapeia Biologics

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‖.
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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.
Therapeia Biologics

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.
Therapeia Biologics

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‘.
Therapeia Biologics

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.
Therapeia Biologics

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.
Therapeia Biologics

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.
Therapeia Biologics

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Therapeia Biologics

SITE MASTER FILE

CHAPTER INDEX PAGE

1.1 Brief Information of the firm. 1

2.1 Organization chart showing the arrangements for Quality 9

2.4 Personnel Hygiene Requirements Including Clothing 10

3. PREMISES & EQUIPMENTS 17

3.1 Description of manufacturing area. 17

SITE MASTER FILE

CHAPTER INDEX PAGE

3.4 Special area for handling of highly toxic hazardous and 19

4.1 Arrangements for the preparation, revision and distribution 22

5.1 Brief description of productional operation using, 24

SITE MASTER FILE

CHAPTER INDEX PAGE

6.1 Description of the Quality Control System and the 27

7. DISTRIBUTION, COMPLAINTS & PRODUCT 29

7.1 Arrangements and recording system for distribution. 29

8.1 Short description of the Self Inspection System. 31

9. LIST OF MACHINARY OF BETA – LACTUM CAP. 32

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

The company has a Pharmaceuticals Formulation Plant located on a

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

1.2 Pharmaceutical formulations manufacturing activities to be licensed by

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

1.3 Name and exact address of the site:

1.4 Any other activities carried out on the site

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The Plant is engaged in the manufacturing of recombinant Hepatitis B

1.6 Short description of the site

Plant Layout: Refer Annexure I

Plot Size: 9000 square Ft.

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

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

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

1. SAMED LABORATIORIES LTD.

1.9 Short description of the quality management system

Total Quality Management is achieved by

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

The Quality Assurance Department is responsible for:

Preparing, issuing and updating Quality Assurance Policy. Maintaining and

Audit operation to asses adequacy of QA systems.

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Monitoring key quality indicators. The Quality Assurance Manager assigned to

Evaluating and approval of all validation protocols.

Specifying sampling procedures.

Audit and approval of vendors and contract manufacturers. Evaluating and

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

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Specifications and Standard Test Procedures (STPs)

Self Inspection & Quality Audits

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Personnel Hygiene & Sanitation

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