Draft Site Master File

A WHO-GMP CERTIFIED COMPANY
Brussels Laboratories Pvt. Ltd.

Changodar, Ahmedabad (Gujarat),INDIA
SITE MASTER FILE
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 1 of 81
SITE MASTER FILE

BRUSSELS LABORATORIES PVT. Ltd.
OFFICE
33, CHANGODAR INDUSTRIAL ESTATE,

SARKHEJ-CHANGODAR HIGHWAY, CHANGODAR-382210
DIST: AHMEDABAD (GUJARAT)
Tele:
TELE : +91-2717-250416
MOBILE: 09904400451
E-mail: [email protected]
FACTORY
Facility

SARKHEJ-CHANGODAR HIGHWAY, CHANGODAR-382210
TELE : +91-2717-250416
MOBILE: 09904400451
GENERAL DEPARTMENTS :
BETA LACTUM
Document No.
SMF/01/01
EFFECTIVE DATE
01/01/12
REVIEW DATE
20/01/13
Confidential Document
TABLETS, CAPSULES,
ORAL LIQUID,
TABLETS,CAPSULES, DRY SYRUP

SITE MASTER FILE
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 2 of 81
Prepared by
Checked by
Approved by
Q.A. Officer
Q.A. Manager
Managing Director
1.0
INDEX
Sr. No.
Title
Page No.
02
1.0
Index
2.0
Approval Sheet
05
3.0
General Information
05
Brief information in the site
06
Pharmaceutical manufacturing activities
06
Other pharmaceutical manufacturing activities
07
Licensable activities
07
Name and Site address
07
Contact persons during and outside working hours
08
08 09
Description of the site

Location of site
08
Number of employee working in plant
08
Use of out side assistance in related to manufacturing and analysis
08
Calibration of critical measuring, Recording and working instruments.
08
Non- viable counting of the new or modified facility and periodic

monitoring.
08
Quality management system
08
Quality policy
09
Responsibilities of the quality assurance dept.
10-11

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4.0
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 3 of 81
Audit Programme
11
Vendor assessment
12
Personnel
13
Organization chart
13
Qualification, Designation, Experience and responsibility of key personnel

In service training and maintenance of records
16
Health requirements for personnel engaged in production
16
Personnel hygiene requirement and clothing
6.0
18
Simple plan for premises
18
20
Air handling system and details
22
Areas for the handling of highly toxic hazardous and sanitizing compounds
22
Compressed air
23
Brief description of water system
24
Cleaning and sanitization of over hand tank
25
Equipments
Maintenance and servicing of equipments
8.0
18-19
Brief description of ventilation systems
Maintenance Programmes for premises
7.0
17-18
PREMISES AND EQUIPMENT PREMISES

Nature of construction and finish of critical areas of Liquid and Dry Powder
Injectables
5.0
14-15
27-33
27 28
Qualification, validation and calibration Programme
27
Equipment Qualification
28
Equipment and Instrument qualification policy
28
Cleaning and Sanitation
30
Cleaning Procedure
30
Documentation
Preparation, Revision and distribution of documents
Documentation for manufacture
30
31-32

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9.0
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 4 of 81
Production
32
Description of product operation
32
Handling of material ( R.M., PM., Bulk and finish)
10.0
33-34
Arrangement for Handling of Rejected material and products
35
Description of general policy of process validation
35
Revalidation policy
36
Cleaning validation
36
Quality Control
37
37-3
Quality control system

Retain sample
38
Stability studies
38
11.0
Loan License Manufacture and Licensee
39
12.0
Distribution, Customer Complaints and Product Recall
39
Arrangement and recording system for distribution
40
Arrangement for handling of components and product recalls

13.0
41-42
43
Self Inspection
ANNEXURES
Sr. No.
Annexure
Particulars
01
Annexure I
Schematic diagram of AHUs.
44
02
Annexure II
Schematic Diagram of Water System
45
02
Annexure III
List of Major Equipments and Instruments used in

Production and Quality control laboratory
04
Annexure IV
Flow Chart- RM/PM Inspection
51
05
Annexure V
Flow Chart-In Process Inspection
52
06
Annexure VI
Flow diagrams of the processes for Tablet, Capsule, Liquid

and Dry Powder Dept.
07
Annexure VII
Flow Chart- Finished Product Inspection
08
Annexure VIII
Photocopy of Manufacturing Licenses
46-50
53-56
57
58-60

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Review Date
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09
Annexure IX
Photocopy of GMP Certification
61
10
Annexure X
Photocopy of WHO-GMP Certificates.
62-63
11
Annexure XI
List of Products (Tablets, Capsules and liquids)
64-81
This Site Master File is accepted as a policy document by the Management of

BRUSSELS LABORATORIES Pvt. Limited
Changodar,
Ahmedabad, Gujarat,
India
2.0
APPROVAL SHEET
Prepared By
Manager- Quality Assurance &
Regulatory Affairs
Sign
Date
Reviewed By
Production Manager
Sign
Date
Chairman
Approved by
Managing Director
Sign
Date
Sign
Date
Authorized By
Mr. A. C. Patel
3.0 GENERAL INFORMATION

Brief Information on the Firm, relation to other sites and in particular any information
relevant to understanding the manufacturing operations.
BRUSSELS LABORATORIES Pvt. Ltd. is a closely held, professionally managed, WHO-GMP
Certified Pharmaceutical company; manufacturing various dosages forms and located at
Ahmedabad city in Changodar Ind. Estate area of Changodar.
Brussels has recorded an excellent growth to reach its present standing as a growing
company in the area of health care. The company exports to around the countries, both
developed and developing. The company enjoys a rich-manufacturing experience of 10
years as established in the year 1998 & Over the last 1 years has made noticeable

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Effective Date
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Review Date
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progress, and is as on today one of the leading pharmaceutical company in Gujarat in the
area of Healthcare
BRUSSELS LABORATORIES Pvt. Ltd. establishes of various disciplines are working towards
the objective of continuous improvement in quality. BRUSSELS products are exported
to many countries.
This Site master file is related to Tablet, Capsule, Liquid and Dry Powder in Beta-Lactum
and Non Beta-Lactum Dept. facility of M/s BRUSSELS LABORATORIES Pvt. Limited
Industrial centre, Changodar, near to Ahmedabad, Gujarat, India.
This site manufacturer Tablets, Capsules, Liquids, Dry Powders, Beta-lactum and Non
Beta-lactum Dept. Products.
Pharmaceutical manufacturing activities as licensed by the national authority
At the above address we held the following drug manufacturing license as per the
categories shown against and as issued by the State Food & Drug Control
Administration, Gandhinagar -Gujarat. Schedule C-& C1, License No. G/1369 in form No.
25 and G/1010 in form No. 28 and Manufacturing activities are carried out on the site.
Company manufactures and sales the products covered under the broader categories of
Beta-lactum and Non Beta-lactum :
1. Tablets,
2. Capsules,
3. Dry Syrups,
4. Oral Liquids,
Any Other Manufacturing Activities carried out on the site

Name and Exact Address of the site, including Telephone, Fax Numbers

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Revision Number
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Effective Date
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Review Date
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Plant Address
Registered Office.

SARKHEJ-CHANGODAR HIGHWAY,
CHANGODAR-382210

CHANGODAR-382210
TELE : +91-2717-250416
TELE : +91-2717-250416
Mobile:09904400451
Mobile:09904400451
Telephone No. of contact person:

(1) Mr. Divyang C. Patel.
Managing Director
Mobile: 09904400451
Types of Product Categories of Beta-Lactum and Non Beta-Lactum. Manufactured at the site
Manufacturing Products Range Includes:
1.
2.
3.
4.
5.
6.
7.
8.
9.
Psychiatrics
Anti Malarias
Antibiotics
Anti Inflammatory
Analgesics
Antiemetic
Antacids
Anesthetics
Others
No Toxic or Hazardous substances are manufactured over here.

Short Description of the Plant
Name
: BRUSSELS LABORATORIES Pvt. Ltd.
Address
: 33, CHANGODAR INDUSTRIAL ESTATE,

CHANGODAR-382210. DIST: AHMEDABAD
(GUJARAT)
TELE : +91-2717-250416

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Document Number
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Revision Number
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Effective Date
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Review Date
20/01/13
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MOBILE: 09904400451
Company Activities
: Manufacturing & Sale of Pharmaceutical Beta-lactum

and Non Beta-lactum Products including,
1. Tablets,
2. Capsules,
3. Dry Syrups,
4. Oral Liquids,
Factory Details
: Plot Area: 1750 sq. meter

Built up Ground Floor
Built up First Floor
Built up Misc
Total built up
: 822 sq. meter

: 822 sq. meter
: 34 sq. meter
: 1678 sq. meter
The factory has built up area 1678 sq. meter. The connected power capacity is 125 HP.
The storage area is well maintained and has air conditioning facilities to store drugs /
products in a cool place. Plant has capacity to produce 250 & 300 lt. per hour for Purified
water on a continuous basis. All the toilets are integral with automatic flush. Auto tape
and hand dryers in place.
The whole facility is well maintained at all times with adequate and prompt repairs and
paintings and servicing.
Number of Employees engaged in Production, Quality Control, Storage and
Distribution
Production
Quality Control
Quality Assurance
Stores
Distribution
:
:
:
:
:
50
04
02
04
02
Use of outside Scientific, Analytical or Other Technical Assistance in relation to

Manufacture and Analysis
We take assistance of outside analytical laboratories for sophisticated test. The said
parties are as follows:
1. GUJARAT LABORATORIES
: Ahmedabad

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2. THE GITAR LABORATORIES
Document Number
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: Ahmedabad
Company uses outside expertise for pest and rodent control, calibrations, filter integrity
test, Validation activities and training and medical services.
Calibration of Critical Measuring, Recording & Weighing Instruments
Primary calibration as per traceability report of vendor and secondary calibration
Other services obtained from the external agencies as per calibration schedules.
Non-viable counting of the new or modified facility and periodic monitoring
Primary monitoring as per traceability report of vendor and secondary monitoring
Other services obtained from the external agencies as per calibration schedules.
Short description of the Quality Management System of the firm responsible for
manufacture
Quality division of BRUSSELS LABORATORIES Pvt. Ltd is a distinct organization body that
functions and reports to Director and is independent of all other plant functions. Head of
Quality division is technically qualified with remarkable experience in the responsible area.
Site In charge Quality Assurance reports to Managing Director. Brussels has adopted a
policy of operating the pharmaceutical manufacturing under control of Quality
Management System, installed and operating as stated under the Quality Manual:
It is also our policy to update the standards as per WHO, cGMP and customer
requirements with mutual dialogue. The quality control department is fully authorized to
take appropriate decision on quality matters.

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Our Quality Policy is
To Manufacture
WORLD CLASS PHARMA FORMULATIONS
To Satisfy
NEEDS AND EXPECTATIONS OF CUSTOMERS
To Ensure
EMPLOYEE INVOLVEMENT
To Build
QUALITY AT EACH AND EVERY LEVEL
To Assure
COMMITMENT TO SAFETY
To Invest in
CONTINUOUS IMPROVEMENT

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Responsibilities of Quality Assurance Department

QA group is responsible for maintaining total quality of systems and products as per WHO &
cGMP requirements. Major responsibilities covers:
Ensure compliance of national and international regulatory WHO & cGMP
requirements.
Approve and verify implementation of defined systems, standards and procedures.
Ensure availability of approved procedures and specifications for reference.
Review Batch manufacturing and testing records, before giving product release.
Review and authorize Validation master plan, Protocols and provide support for
validations.
Ensure compliance of Change control procedures.
Ensure induction and training of employees as per Induction and Training Policy.
Ensure compliance of WHO-cGMPs through audits.
Carry out process controls, including in-process checks/inspections/line clearances.
Inspection of final packed stock, before release.
Investigate complaints, deviations, quality incidents and non-conformances.
Handling of regulatory inspections at the site.
Take actions on product recalls and investigate the reasons.
Ensure implementation of amendments in specifications and procedures as per current
pharmacopoeia standards.
Ensure implementation of pest and rodent controls, as per defined schedules.
Review product stability reports.
Review batch manufacturing records, verify reconciliation of batch inputs, batch yields
and finally release the product.
Document control.
Ensure WHO-GMP / cGLP training to the staff.
Ensure proper storage and fast Retrievability of records.
Annual Product Quality Review
Developing quality policy & standards.
Analytical method development
Vendor development and approval
Support to validation activities
Internal audit
To review and approval of master validation program, including equipments, processes,
facilities, analytical methods etc.

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To investigate out of specification results or failure investigation related to testing or

manufacturing etc.
To review and upgrade the quality systems as per the latest regulatory requirements on
periodical basis.
To liaison with overseas customers on quality related issues and regulatory bodies on
audit and their follow-up.
To review and approval of art-work of all finished packaging material including contract
manufacturing locations.
To review SOPs related to quality assurance and manufacturing activities
To ensure sampling of raw-materials and packaging materials as per company
procedures.
Audit Program
Audit program or self-inspection and Vendor assessment are implemented with aim to
evaluate the effectiveness of the applied- quality system and ensuring that every step in
production process is in accordance with WHO-GMP principle.
Self Inspection:
Periodical self inspection is made during manufacturing and processing from raw
material receipt to finished products dispatch. The purpose of self-inspection is to
evaluate the compliance with WHO-GMP in all aspects of production and quality
assurance. The self-inspection is to evaluate quality system. The self-inspection
programme is designed to identify any shortcomings in implementation of WHO-GMP,
and to recommend the necessary corrective action. Self-inspection is performed
routinely.
Self-inspection team from internal staff from different departments and are expert in
their own field and familiar with WHO-GMP. A report is made at the completion of Selfinspection which includes:
Self-inspection results.
Recommended corrective actions.
Evaluation and conclusion.
Evaluation is made by company Management for both the self-inspection report and the
corrective actions taken.

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Vendor Assessment
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.
Below is a summary of the activities necessary for the approval of a vendor:
Identification of vendor.
Calling for quotation.
Vendor evaluation through questionnaire.
Vendor selection and audit
Vendor approval
In case of active substances, first three consecutive batches manufactured, using material
from the new source are subjected to process validation as per the approved validation
protocol. The Active Raw Material (s) and Finished Product of the first three batches are
placed on stability studies as per ICH guidelines.
Overseas Vendors are assessed through Questionnaires, which is designed to understand the
Standards followed by the vendor.
Vendors Supplying Active materials are audited once in 2 years, primary packaging material
once in 2 years, Excipients (inactive materials) once in 3 years and secondary packaging
materials once in 3 years.
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 and analytical reports. Manager-Quality Assurance authorizes the release of the
product for sale/ distribution.

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4.0 PERSONNEL
Organization Chart showing the arrangements for quality assurance, including production
and quality control
Quality Assurance Function is independent of all other plant functions. All site managers reports to General Manager who in turn reports to the Director.
Managing Director
General Manager
Manager
Purchase and
Administration
Manager
QC
Officers
(Liquid)
RM Store
In charge
PM Store
In charge
Manager
Production
Officers
(Tablets)
Finished
Goods
Store
In charge
Q.A. MANAGER
Officers
(Capsule)
Housekeeping
In charge
Executive
QA
Executive
QC
Officers QC

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Qualification, Designation, Experience and Responsibility of Key Personnel

Name of the
Person
Mr. A.C.PATEL
B.Sc., D.PHARM
Chairman
26Yrs.
Mr. D.C.PATEL
B.COM
Managing
Director
11 Yrs.
Mr. Pravin
Chaudhary
B.Sc.
(Chemistry)
Q.A. Manager
19 yrs.
Qualification
Designation
Experience
Brief Responsibilities
To identify and approve the new market
for the company's product.
To interface with the customers vis--vis
company's product.
To interface with the larger manufacturers
for manufacturing their products on
contract basis.
To finalize the terms of the contract for
contract manufacturing.
To manage the finished goods store for
ensuring the minimum inventory.
Vendor development in consultation with
Head Quality Assurance.
To co-ordinate with M.D. for production
planning and purchase activities.
Material Procurement as per
specifications.
To maintain the vendor appraisal /
Evaluation.
To take the stock of inventories.
Developing new product formulation and
implementation for Production.
Give training to shop floor and upper level
personnel when required.
To issue guideline for corrective actions
for non-conforming product.
To update formulations and printed
packing materials to meet Regulatory
requirements.
Maintain productivity with quality.
Monitoring of compliance with WHOcGMP requirements.
To initiate actions to resolve nonconformances.
To maintain adequate documents
pertaining to the activities for which
he/she is responsible.
All quality assurance activities. Vendor

SITE MASTER FILE
Mr. Jatin Darji
Delvadia
Manshukhlal.G.
Mr. Rahul Dabhi
D.Pharm
B.Pharma
D.Pharm
Q.A. Chemist
Production
Incharge.
Production
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1 year
30 yrs.
1 year 5
month
development activities Prepare Master

Validation Plan Preparation, issuing and
reviewing of SOP, BMR and Master cards.
As per Master Validation plan work on
prospective, concurrent and Retrospective
validation Prepare Annual product review.
Prepare documents and manuals for
stability study, Quality, Safety water
system etc.
Batch manufacturing, Documentation,
New SOPs, BMR preparation, maintain the
area as per WHO-cGMP.
To perform Q.A.Activity sampling of raw
materials and finished products. Doing In
process testing.
To maintain the Tablet & Capsules
department. Prepare weekly production
planning for Tablet Section.
Monitor day to day productivity. To
ensure that Manufacturing & packing is
carried out as per S.O.P.Maintain WHO
GMP in the section.Ensure that the
appropriate process validation and
calibrations of control equipments are
performed and recorded and the reports
made available.
To ensure that the required initial &
continuing training of production and
packing personnel. Handling of labors.
Follow up with loan license parties,
purchase, Maintenance and quality
control department for their respective
work.
To maintain the Liquid department.
Prepare weekly production planning for
Section.
Monitor day to day productivity. To
ensure that Manufacturing & packing is
carried out as per S.O.P.Follow WHO-GMP
Ensure that the appropriate process
validation and calibrations of control
equipments are performed and recorded
and the reports made available.
To ensure that the required initial &

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continuing training of production and

packing personnel. Handling of labors.
Follow up with loan license parties,
purchase, Maintenance and quality
control department for their respective
work.
Liquid Section.Monitor day to day
productivity.To ensure that Manufacturing
& packing is carried out as per S.O.P.
Tablet Section
Bhavesh Jayswal
B.Pharma
Production
Officer
1 year
Patel Jay
M.Pharm
Production
Officer
1 month
Raghuvanshi
Pradeep
B.Pharm
Production
Officer
6 month
Patel Manisha
B.Sc.
Q.C.Chemist
6 year
Parmar Jaydeep
B.Sc.
Q.C.Chemist
6 month
Bhavsar Ravi
B.Sc.
Q.C.Chemist
10 month
Parmar Rakesh
B.Sc.
Store Incharge
5 year
Store keeping records and area as per

WHO GMP.
2 year
Keeping records for DM Water recharge

and AHUs .Maintenance of all utility of
Plant.
Patel Kishan
Mr. Pramod Thakur
D.M.E.
Maintenance
B. Sc.
Q.C.Incharge
20 yrs.
Monitor day to day productivity for

capsule section.To ensure that
Manufacturing & packing is carried out as
per S.O.P.
Overall Quality planning and monitoring.
To approve Quality Control procedures as
per cGLP.To setup system which have a
bearing on quality. To perform testing of
raw materials and finished products.
To approve new products for launch.
To approve design change.
Preparing & updating Quality manual.
To perform testing of raw materials and
finished products.
Overall responsible for quality analysis

and follow GLP.Maintain records and
SOPs laboratories as per WHO-GMP
Overall Quality planning and monitoring.
To approve Quality Control procedures as
per cGLP.To setup system which have a
bearing on quality. To perform testing of

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raw materials and finished products

Mr.Hemal Vyas
B.Sc.
Production
Officer
4 year
Monitor day to day productivity.To

ensurethat Manufacturing & packing is
carried out as per S.O.P.
Arrangement for Basic and In-service Training and Method of Records Maintenance
Training has been identified as the key area for updating the skills and WHO-cGMP
knowledge of personnel engaged in various activities at the site. Induction and Training, is
given to new entrants employees at the site. The department managers identify training
needs. Based on the identified training needs and the annual training schedule on SOPs and
WHO-cGMPs, training sessions are conducted by qualified trainers of the organization.
Training Evaluation is done through questionnaires.
Manager Q.A. compiles training records in the individual training files of employees.
Training records include attendance sheet, answers to questionnaires, evaluation and
trainers comments. Based on Trainers assessment, re-training needs are identified.
M.D. is responsible for identifying the training needs of the departmental heads &
departmental heads are responsible for person working under them. Training programme is
organized individually or in a group and is based on the area of operation of the staff. Mainly
following topic are covered during training.
Responsibility & awareness of job.
Cleanliness, clothing, sanitary & personnel hygiene.
Management training.
Material handling & cross contamination.
Operation of instruments & equipments.
Productivity related activity.
WHO-GMP/GLP awareness.
The records of training are maintained by Departmental head as:
People trained
Topics covered/faculty
Results of training
At a later date QC/QA heads review the effectiveness of training imparted.
Health Requirements for Personnel engaged in Production (Process)
All persons engaged in production should be free from infections and communicable
diseases. In order to conform to the above requirement, the following precautions are
taken:

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Medical examination of all employees is done at periodic intervals and not less
than once annually, by a qualified Medical Practitioner.
For any employee resuming duty after an illness involving contagious disease, a
medical certificate specifying his/her ability to attend to the job is asked for.
In addition to the above precautions, supervisors are always required to keep
Vigil for any signs of disease or weakness in workers.
Personnel working in -lactum area are tested for penicillin sensitivity yearly.
Personnel Hygiene Requirement Including Clothing
The following hygiene conditions are expected of the workers engaged in manufacturing:
They are requested to have baths daily and wear a fresh set of garments.
On reporting to work and before entering the manufacturing dept., they are required
to change into their work attire.
Hands are to be cleaned at regular intervals using soaps. This is more essential after
visiting the toilets. Wherever possible, hair is required to be clean and inside the
headgear.
Nails are to be trimmed regularly.
In order to make it possible for the workers to adhere to the above requirements,
The following facilities are made possible on part of the management:
Separate washing, toilet and lunch room facilities for lady workers, male workers, and
chemists.
Protective clothing such as:
Working garments
Aprons
Head covers
Plastic leg wear
Face masks
Gloves, etc.
All garments are laundered every day.
Manufacturing facility is equipped with sufficient area for washing, outfit changing/
locker, and resting. It is required for every personnel to use own-area facility and
prohibited to use other class facility (Black facility for Black area employee, Grey
facility for Grey area employee, and sterile facility for White area employee).
Incoming or outgoing flow or access of Production area employee (Black, Grey and
White) is described in employee or material flow, under following rules:

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Black area employee

All employees should change outfit into black area change/ locker room. They should
wear company dress (Apron, Cap and Slippers). Then enter to production area through
Black corridor and proceed to their respective working areas.
White area employee
Employees of White area should follow the rule of entering before entering White
area. Then go to the proceeding white area.
The employees are required to disinfect their hand first, using provided disinfectant
before lay a hand on the garment. They should also pass through the air shower
before entering room.
To assured the hygiene of uniform for white and black-classes, it is changed and
washed to confirm that the uniform cleanliness and washing are well maintained.
5.0 PREMISES AND EQUIPMENT PREMISES
Simple Plan of Description of Manufacturing Areas
Lay out of manufacturing area, complete with flow of material and personnel are
available on Annexure.
Nature of construction and finishing
The manufacturing premise has RCC (reinforced concrete cement) constructed with
the following features in mind:
To prevent entry of insects and rodents.
With smooth interior surfaces free of cracks and crevices-in order to allow easy
cleaning and disinfection.
Adequate lighting facilities.
Proper sanitary drainage systems.
To allow minimum Material Handing.
Material and construction of production building are as below:
Section
Black Area
White Area
Wall
Material
Brick
Brick
Floor
Material
Surface finishing
Material
Surface finishing
Concrete
Self leveling
Concrete
Surface finishing
Concrete
Self leveling
Concrete
Surface finishing
Ceiling

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The angle created between ceiling and wall, and between wall and floor is not in the form
of making a corner angle, but it is the curved shape with minimum radius of 3.5 cm
(particularly for gray and white area).
Door type (including the frame) and window frame for Production room is designed
under following method:
Section
White Area
Material
Door
Design
Surface
finishing
Material
Viewing
Panel
Design
Surface
finishing
Aluminum and glass

Every angle forms a
circular shape
Black Area
Aluminum and glass
Every angle forms a circular
shape
Smooth
Smooth
Aluminum framing and

glass
Flushed to walls
Aluminum frame with
transparent glass
Aluminum framing and glass

Not defined
Aluminum frame with
transparent glass
Opening to wall (including electrical socket), floor or ceiling for pipe line or air/ water duct, should be
sealed or closed by open able cover, so that it remains cleaned and dust free.
Brief description for Ventilation systems. Critical areas with potential risks of
airborne contamination. Classification of the rooms used for the manufacture of the
sterile products .We have 10 nos. of A.H.U.s for different operational areas as 8 for
production and 2 for QC - Micro department. We divide Air Handling System into 4
(four) classes. They are:
Room Class
Air change
(amount of
ventilated air per
hour)
Pre Filter
(%)
Medium
Filter (%)
Temperature
o
( C)
RH (%)
Fresh
air (%)
Remark
Zone A
(White)
>60
30-40
80-85
18-27
40-70
10
Under
laminar air
flow
Zone B
(White)
>40
30-40
80-85
18-27
40-70
10
Backgroun
d of

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laminar air
flow
Zone C
(White)
Zone D
(Grey)
Zone D
(Grey -Low
RH)
Black
(*)
>30
30-40
>30
30-40
>30
30-40
ND
30-40
80-85
90-95
90-95
18-27
40-70
10
------
18-27
45-70
10
------
18-27
20-40
10
------
NA
20-28
45-75
10
NA
MPPS: Most Particle Penetrating Size

The company also maintains pressure differences among production rooms in the same class
as well as between different classes to prevent cross contamination. The procedure is as
follows:
A more negative pressure is applied into a dusty room than it is in the (connected room
or) corridor.
A more positive pressure is applied to a less dusty room than it is in the (connected
room or) corridor.
A more positive pressure is applied to rooms for sterile processes than it is in
surrounding rooms.
A more positive pressure is applied to intermediate room than it is in the lower class
room.
Pressure difference between one room and another that has lower risk or higher risk
should be applied significantly, that is 15 Pascal or 1.0 - 1.5 mm of water in ascending
order to adjacent room.
Every room class is equipped with air filter according to particle size and amount.
Black class: is equipped only with pre-filter and secondary filters delivering 5 filtrate air
Grey class: is equipped with pre-filter, secondary filter and terminal filter
White class: is equipped with pre-filter, secondary filter and
Note:
MPPS test is based on 0.3 medium and HEPA filter

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Every AHU is equipped with Flow Measuring Sensor to detect pressure and air velocity
inside ducting. The end result is maintained room condition according to requirement.
Every fresh air intake and ducting return equipment (particularly in White area), is
equipped with pre filter (20 + 10), secondary filter (5) and terminal to filter micron
guarantee the cleanliness of incoming and outgoing airflow.
Validation to air management system is implemented by:

1.
2.
3.
IQ of AHU system are implemented at the initiation of operation, and if system

change is applied.
OQ of AHU system is implemented at the initiation of operation (after IQ
completed) and periodically twice a year (and/or if any changing to the system
applied).
PQ is implemented periodically (at least once every year) and monitoring datas
on daily basis.
Every room inside white area undergoes daily check periodically. The frequency of white
area checking is more frequent than grey area checking.
Special areas for the handling of highly toxic, hazardous and sensitizing materials
None
Compressed Air Unit
The compressed air unit is used for:
a) Manufacturing Area
A schematic diagram of the compressed air unit can be found in following area with
sampling point.
In all the other user points (Packing Area, de-mineralized water plant), the compressed
and oil free air does not come into contact with the product.

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Schematic Diagram of the Compressed Air Unit
FILTRATION
LEVEL
10% Fresh Air
0.3
HEPA
FILTER
20
Micron
10
Micron
10 Micron
Filter at
Room
level
5 Micron
0.3
Micron
Manu
Area
VCD
5 Micron
Filter
Base Frame
Fan Section
VCD
Coil Section
VCD
Fresh
Air
10 Micron
Filter
Room level
20
Micron
Filter
VCD

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Description of Water Systems Including Sanitation

For manufacturing purpose water for beta-Lactum and is used. For cleaning of containers,
vessels and areas, De mineralized water line is provided
A.
Description of Water System

Potable Water Making Process
Potable water is obtained from GIDC supply. The water is injected with chlorine to prevent
microorganism growth. The raw water is stored in under ground tank, then pump into
overhead raw water storage tank.
Potable water is used as the source of purified water after pass through filter of 50 .
Purified Water making process
Potable water is transferred in to RO Plant for water purification before pumped into RO
water storage tank and D.M. Plant.
The water in RO Machine is transferred through sand filter and carbon filter to lessen
dissolved CO2, dissolved solids in water that could influence purified water conductivity.
Afterward it is injected with Antiscalant and antioxidant solution to eliminate the
remaining chlorine that could prevent RO membrane damage.
The water is then pumped using High Pressure Pump onto RO membrane by passing
through 20 and 10 filter.
RO Water stored in RO Water Storage Tank. The storage tank is made of 316 L stainless
steel tank. It has ventilation covered by sterile filter with porous surface of 0.2-micron size
and hydrophobic characteristic to prevent incoming microorganism.
RO Water is than pumped into D.M. Water plant and the prepared D.M. Water is stored in
5 KL overhead D.M. Water storage tank
Purified water from storage tank is distributed by sanitary pump with minimal flow
velocity of 1.5 m/s which is functioned to create inside-pipe-turbulence in order to

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prevent bacterial growth (bio-film) and circulated continuously inside piping structure
designed to avoid dead leg. Piping system is designed with min 0.5% 1% slope to
facilitate fully drainage. Pipe material use 316 L stainless steel with less than 0.6 Ra
refinement level for direct contact to product surface (pipe welding is designed to be
non-porous and smooth). RO Water is distributed.
The drain water from above all machine is collected in 5 KL storage tank for boiler feed
water.
Every user point is equipped with zero dead leg diaphragm valves to avoid dead/ unused
point. Valve installation is placed on every looping pipe.
Sanitation system utilizes boiled purified-water until 80oC and it is circulated in a specific
period of time based on validation data.
Piping and tank sanitation is implemented routinely based on validation data gathered.
Purified water functions as:
Solvent for non sterile production process
Cleaner of particular equipment
Water supply to distillatory for Water-for-beta-lactum and production
Water supply for pure steam generator.
Water for final rinsing on cleaning process in grey area (D class)
Sanitation
Sanitation activities for water treatment system are implemented based on validation data
and result of inspection data that conducted daily/ weekly and monthly, with refer to each
requirement specification.
Data from validation and routine inspection are evaluated to define period of time
sanitation.
Sanitation program for Water are grouped into Potable Water Sanitation, Purified Water
Sanitation.
Potable water sanitation use Chlorine that injected periodically accompany deep well
pump running, dose chlorine is based on result of routine inspection and requirement for
Potable water (maximum Chlorine compound in Potable water is 0.4 ppm)
Purified Water plant sanitation use Purified Water that heated up to 80 C in purified
water tank and circulation to all pipe line for 1-2 hour (depend on validation data) and
afterwards the water is drained via drain sanitary valve and all user point valve.

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Frequency sanitation is based on Validation data and result of routine inspection and
condition of Purified water itself (if the parameter reach action limit, sanitation should be
done immediately)
Frequency of sanitation is based on Validation data and result of routine inspection and
condition
of WFI itself (if the parameter reach action limit, sanitation should be done immediately).
Description of Planned Preventive Maintenance Programs for Equipment and of the Recording
System
In order to ensure that all equipments and machines perform effectively, the site Engineering
Department carries out planned preventive maintenance.
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 authorized by Utility-Incharge.
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 Asst. Manager - Quality Assurance.
If any equipment/machine needs servicing, the operator of the equipment reports to the
department officer 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.
Microbiological controls for environmental conditions like Air, Water and also finished products
as per written procedures.

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EQUIPMENTS
Maintenance of any nature follows the following route.
DEPARTMENT RAISING MAINTENANCE REQUISITION

MAINTENANCE OFFICER
TRAINED TECHNICIANS
RECTIFICATION / REPAIR
Maintenance implementation begins with maintenance master list designing. The list covers
every production, QC, PD, warehouse and supporting facility equipments that need to be
maintained, such as: AHU, water system and electrical system, which pose direct or indirect
influence to product quality.
Maintenance schedule is arranged and the documentation is written on Machine card
acknowledged by user. Before maintenance program is being conducted, maintenance
department should notify the user concerning schedule of maintenance to be conducted to
assure that user have prepared the machinery and Equipment for maintained.
Implementation of maintenance should not be carried out in the area of where production is
processing or any of the bulk products are existed. It should not be executed if potential for
any room contamination occurred. Should the program be conducted, air inlet and air
return of the area should then be closed.
It is periodically evaluate and analyze the relevancy of maintenance schedule realization,
based on equipment master list, SOP and Operational Manual Book of each tool,
maintenance schedule and maintenance item is arranged.
Qualification, Validation and Calibration

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Validation is conducted by in purpose to consistently yield qualified products which comply

with the defined specification.
The validation performed by validation team, which have as the member are delegation
from every related department, i.e.:
-
QC/QA Department
Production Department
Product Development Department
Maintenance Department
To organize the activity of validation program, the validation team has designed a master
plan of validation (Validation Master Plan) as the guidance for validation implementation.
Coverage of Validation Master Plan:
- Validation Team (holding responsible to conduct the validation program).
- Matrix of Pre Validation
- Schedule of Pre Validation Program
- Matrix and Schedule of Validation
- List of Validation Protocol
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.
Equipment Qualification
Equipments are subjected to URS, DQ, FAT, IQ, OQ & PQ as per pre-approved protocols.
Operating, cleaning & maintenance procedures are written down & 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 & finally signed off.
Equipment / Instrument Calibration Policy:

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List of laboratory equipments, measuring, site technical people in co-ordination have drawn
out recording, weighing devices that require being calibrated with maintenance engineer.
Method of calibration & frequency is defined for each laboratory equipment & critical
instruments. Out of calibration equipment/ instrument is reported immediately to manager
quality assurance and concerned department In-charge. Replacement is recorded.
Destruction of replaced instrument is done immediately & recorded. Impact of out of
calibration is assessed & actions taken.
Calibrated equipments/ instruments are labeled. Date of calibration & next due is
highlighted on the label. Out of calibration equipments/ instruments are conspicuously
labeled OUT OF CALIBRATION, NOT TO BE USED.
Repaired equipments/ instruments are calibrated immediately. Company uses outside
expertise also for calibration of instruments. Manager quality assurance and production
reviews such calibration reports. Traceability certificate and calibration validity of standard
equipment is also ensured along with calibration certificate.
Calibration records are maintained and kept with the manager quality assurance.
Validation
Validation is classified into 3 (three) categories, which are:
a.
Validation of Cleaning and Sanitation Procedure

Validation of cleaning and sanitation procedure is conducted as to assure that the
procedure of cleaning and sanitation for processing machine, equipment, production
room including processing and packaging area are consistently in line with the
defined acceptance level for remainder active ingredient, detergent and
microbiology.
Cleaning validation of every cleaning procedure is performed once in 2 (two) years,
or if any update/new method of cleaning to be implemented.
b.
Validation of Analytical Method

Validation of analysis method is conducted to all product produced, which analytical
method used has not precisely comply with pharmacopoeia method. This validation
is also conducted on analytical method of finished goods, if it is also not precisely
comply with pharmacopoeia method.
Validation of analysis method is performed on the same product periodically once in
2 (two) years, or if any reformulation or revision on analytical method conducted.
c.
Validation of Production Process

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Validation of production process is conducted at critical steps of production process

that might significantly affect the finished product. It is also as to assure the
consistency of the product manufacturing process.
7.0
Cleaning and Sanitation

Cleaning and Sanitation activities are implemented according to Sanitation SOP. They
are grouped into room cleaning and sanitation, machine cleaning and sanitation and
processing tool cleaning and sanitation. The activity begins with recapitulating room
cleaning and sanitation master list and machine and processing tools master list.
Recapitulation is designed under consideration of cleaning method , sanitation
material used, cleaning agent/ disinfectant, cleaning agent/ disinfectant changing
frequency, and inspection item (i.e. acceptance criteria, inspection/ examination
frequency, person in charge of validation implementation). Periphery of building is
also daily cleaned. The walls, roof, gates and doors of building are periodically
maintained and cleaned.
Detail of working steps is recorded in SOP for routine sanitation implementation, and
every sanitation personnel should follow the SOP.
Cleaning and Sanitation implementation method recorded in SOP is validated by QCs
Microbiology team. The validation includes: measuring of residual active material,
rinsing cleaning agent, microbiology content and comparing the measurement to
acceptance criteria of the above master list to ensure that sanitation method is
effective. Validation is implemented 3 (three) times according to validation SOP.
Validation implementation is repeated according to required frequency in master list.
Record and data of validation implementation is kept by QA / QC department section
Microbiology together.
8.0
Documentation
Arrangements for the Preparation, Revision, and Distribution of Necessary Documentation
for Manufacture
All related documents to production, QA/ QC, PD and process related operation (SOP, SOI,
Internal Standard, Lay out, Master Batch Record (BMR) are controlled documents. Their
circulation is controlled by Document Controlling Center and stored as files under unlimited
length of time until the next revision emerges. The site follows a well-defined system of
document control. There is an approved procedure, which explains the system of document
preparation, revision, distribution, storage and destruction of the obsolete documents.

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Their title and a unique document number with revision level and date of next review
identify all documents. Master copies of all the documents are maintained by the site
Quality assurance department, except the master copies of corporate policies, which are
kept at the corporate Quality assurance. Photocopies of the master copies are issued to the
user departments as a controlled copy and / or a display copy, which are identified with
different color stamps. The procedures are reviewed at specified frequency. When
document is revised, the master copy is retained as obsolete copy and the other copies are
collected from other department by QA and destroyed.
Manager - Quality Assurance 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 heads and finally authorized by Manager Quality assurance.
Specifications for raw materials, packing materials, intermediates and finished products are
prepared by the Quality control officer, checked by executive Quality control and approved
by Manager Quality control and finally authorized by Manager Quality assurance.
Application of the above documents will produce record or data that is stored by each
related department. Record of batch data is stored at least for 1 (one) year from product
expiration date or 4 (four) years from manufacturing date for finished product without
expiration date. Other record that has indirect correlation or non-related to product batch
processing, is stored for 5 (five) years from published date.
Documents are arranged according to stipulated format for each document. Prior to
publishing the Document Application Form and document draft is forwarded to related
department for review and approval. Document application that has been approved by
related department is delivered to Document Controlling Center for publishing, which then
issue a specific number for the document that indicate companys name, document type
(SOP/BMR), document order and document revision number.
Published document will be copied and distributed to related department as controlledcopy, which circulation is under responsibility of Document Controlling Center.
Production process documentation starts from raw material and packaging material
preparation process until finished product is ready to be sent to warehouse, all information
is written in Manufacturing Batch Record (BMR). Product Development prepares BMR that is
based on formulation result and stability data that meet requirement.
BMR contains (at least):
1. Material Requisition (MR)
- Raw (Material) MR
- Packaging (Material) MR

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- Weight ticket MR
- Packaging ticket MR
2. Processing BMR
- Raw Material Master Formula
- Bulk Production Order
- Processing Procedure (Processing Instruction)
3. Packaging BMR
- Packaging Material Master Formula
- Packaging Material Order
- Packaging Procedure (Packaging Instruction)
4. Packaging Material Reconciliation
5. Finished Product Reconciliation.
Master BMR designed by PD Department is stored by Document Controlling Center as
the Master Document. BMR copy is stored in computer and protected by password
authority of read-only and authorized-to-change user.
BMR for production
implementation is printed (as a printed-copy of BMR Master) by PPIC department.
Data yielded on production process implementation (processing data, inspection data,
data maker personnel and created date), inspection process, and environment
condition (room temperature, RH, Air control include particle and microbiology on air,
water (if necessary)) related annexes are written down in BMR as a record.
Completed BMR document and its annexes are handed over to QA/QC Department to
be checked for completeness and kept as a file.
All documents of SOP/BMR is distributed and controlled by Central Document
Controller to related department, as the guidance to complete the activity of process,
QC, training, calibration, etc.
For BMR, it is distributed on batch production processing only.
9.0 PRODUCTION
Description of Production Operation
All processing activities are designed and made based on documented and clearly
described processing quality plan. The flow is simply described as follows:
1. Tablets,
2. Capsules,
3. Dry Syrups

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4. Oral Liquids,
Every process flow has process-points that describe process detail, related or used
SOP/SOI, machine and room. It also has inspection-points that explain inspection
detail and inspection implementation by person in charge.
The process flow is divided into several steps/ stages, such as material receiving step,
intermediate product stage, intermediate bulk stage, primary and secondary
packaging steps and finished product delivery step. Every step/ stage will go through
inspection process according to acceptance criteria determined by QC Department.
In this stage, it is possible to implement only some steps of the process, such as
primary and secondary packaging steps only.
Arrangements of Handling of Starting Materials, Packaging Materials, Bulk and Finished
Product
Raw Material Receiving Step
Upon receipt of the raw materials/packing materials, the material is unloaded on the
receiving bay. The correctness of the material received is checked with the delivery
note. The details are logged in the inward register. Suppliers batch number and the
quantities are cross verified. A Material receiving note is prepared, immediately
QUARANTINE LABEL enclosed on all containers and GRN forwarded to Quality control
department for sampling. Sampling is done by trained samplers as per the approved
procedure. Sampled containers are labelled with a yellowish orange UNDER TEST
LABEL and Sampled/Sampling is indicating on Label. The label indicates name of the
material, 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 pasted and if it does not
meet the specifications , a red REJECTED label is pasted on the containers.
Sampling plan and quantity to be sampled are defined in the sampling procedure.
Approved materials are transferred from under test 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
lies with the warehouse. Dispensing of materials is a controlled operation carried out
by warehouse personnel in presence of production and quality assurance personnel.
Dispensing and sampling of raw materials is done under class 100 conditions.

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Weighing
Materials are issued by stores on receipt of authorized requisition sheet, which is a
controlled document and approved by Manager Quality Assurance or his authorized
deputy. Using calibrated balances does dispensing.
For identification purpose, Weight ticket is attached on every container of weighing
result.
Q.A. supervisor confirms the correctness, quantity and criteria of weighed material of
all weighing result.
Production Process
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.
Processing activity is implemented according to process stage flow of each type of
product and BMR documentation. BMR documentation contains the steps of process
implementation that should be done.
In Process Inspection
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.
QC department is responsible for testing and releasing implementation in production
process according to process flow of inspection plan. Testing and releasing
implementation is guided by stipulated receiving parameter.
Finished product
Intermediate products are analyzed 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 dispatch 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 approved finished product storage area for dispatch.

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Arrangements for the Handling of Rejected Materials and Products

Rejected product or material is identified clearly and place in separate location to
prevent unwanted/ accidental usage. If the material/ product are to be destroyed,
destroying program note is made and the data is kept in material record or in BMRfor-product document.
Procedures for control of non-conforming products have 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 authorized persons. 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 Asst. ManagerQuality Assurance, who investigates the problem.
The matter is referred to corporate technical team for action.
Corrective action could be either (i)
Rejection or
(ii)
Reworking to meet the specifications.
Help of Formulation and development department is sought to provide the

reprocessing procedure. Batch is reprocessed and kept under stability studies. Before
reprocessing any product, necessary approval shall be taken from the customer.
Details of any non-conforming products and any corrective action taken are recorded
and a record is maintained.
General Policy for Validation Process
Validation activity for product is divided into 3 (three) stages/ steps, which are:
prospective, concurrent and retrospective validation.
Prospective Validation
The Prospective Validation is conducted during implementation of first of 3 full scale
of commercial batches (based on validation BMR as the result of trial and developing
formulation by PD department). Prospective validation conducted for 3 continuous
batches where the validation result comply all requirements
(In house, USP, BP and IP Standards) and satisfactory. The first 3 (three) validated
batches will then be used for the next BMR arrangement.

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Concurrent Validation
Concurrent validation conducted once in period of 1 year (latest) after prospective
validation conducted, or if the product has not been produced in one year, concurrent
validation will be conducted on the next production. Concurrent validation conducted
complying with the prospective validated BMR.
Retrospective Validation
Retrospective Validation conducted only for existed (well-established) product, carry
out by collecting historical data of the processing and packaging batch (BMR), the
maintenance, the personnel/personnel rotation, stability trend, including out of
specification batch.
We have defined to collect 10(ten) data point for retrospective validation, which are
collected from batch #10 to Batch #20 (continuously).
Revalidation Policy:
One batch of each product every year.
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.
Cleaning Validation
The cleaning procedures will be validated for three successive product changeovers. The
cleaning will be done as per the defined procedure. The samples will be collected by both
(i) swab method and (ii) rinse method.
The samples will be tested for presence of traces of previous product by the validated
method. Carry over of traces of previous product in the maximum daily therapeutic dose of
the product will be used as acceptable norms of cleaning validation.

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System For release for sale or supply of validation batches

Validation Batches shall be released for sale, provided;
1. Product complies with all pre-determined specifications (In process, Intermediate,
Finished)
2. Batches are manufactured as per the defined formula & process.
3. No evidence of any deviation.
4. Review of batch manufacturing records, analytical reports, validation reports,
Environment conditions do not reveal any deviation to defined standards.
5. Batches are kept on stability studies & at least 03 Months Accelerated data is satisfactory.
6. Customer Approval.
10.0
QUALITY CONTROL
Description for the quality control system and activities of the quality control department
and procedures for the release of finished products.
Quality control department have 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 is responsible for sampling and analysis 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, assays, water testing 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 analyzed in comparison to reference
standards. They are analyzed by two separate experienced analysts, 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 assays and other tests are prepared from material of a
suitable grade in accordance with the approved procedures.

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Experienced analysts perform standardization of volumetric solutions. The results are

verified and records are maintained.
Containers holding volumetric solutions are labeled 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.
The microbiology laboratory is handled by a qualified microbiologist, who has the
appropriate experience in carrying out bio-burden monitoring, microbial counts and
pathogen characterization, microbiological analysis of water, Environment, materials &
Finished Products.
Staff recruited to the Quality control department undergoes initial training 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. Only validated
analytical methods are used in the laboratory.
Retain Samples:
From each batch, a fixed quantity in original 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 as stated in the SOP. These retention samples are examined at specified
intervals.
Stability Studies:
Stability studies of products are carried out as per ICH guidelines at stability study area, located
in the premises. Conditions for stability study are.
Stability Study
Accelerate
Intermediate
Long Term
Storage Condition
40oC 2oC/75% RH 5%or
30C 2C/65% RH 5% RH
30C 2C/65% RH 5% RH
25oC 2oC /60% RH 5%
For the time period of

6 months
6 months
Shelf life
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. These are termed as commercial stability studies. They are
carried out on batches randomly selected as per the standard operating procedure for stability
studies.
The stability chambers results are recorded for temperature and humidity conditions manually.

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11.0 Loan License Manufacturing and Third Party Manufacturing

Contract manufacture and analysis is carried out for the products of,
1. M/s. Augment Remdies.
2. M/s. Swiss Export Pvt. Ltd.,
3. M/s. T & T Pharmaceuticals.
4 M/s. Lincoln Pharmaceuticals Limited.
5. M/s. Gujarat Terce Laboratories Limited.
6.M/s. Nirlife(Nirma Limited)
Above all are under a loan license arrangement. It is correctly defined, agreed and specified
responsibilities relating to the manufacture and control of the Products. All relevant
manufacturing, analytical and distribution records and control samples are kept.
12.0 Distribution, Customer Complaints and Product Recall
Arrangements and Recording System for Distribution
Adequate area is provided at the site for the storage of finished products. Products are stored to
a specified height with proper segregation. Released products are dispatched as per the
directions of Commercial department in closed pre-inspected vehicles or containers.
The products are dispatched to our domestic or overseas customers, who maintain the
distribution records at their end. For overseas customers, the products are shipped in containers
or by air as per the requirements of customer. Product distribution is the responsibility of our
customers/ product owners/ contract givers.

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Arrangements for Handling of Complaints and Product Recalls

Schematic representation of handling market complaints
Recipient
QA & Regulatory affairs
Logging (Date, Nature of complaint, complainant)
Investigation
Investigation report with corrective action

plan- Site QA
Response to the Complainant
Copy of Response
Site Manager QA
Corporate team
approval
Implementation of
CAPA (Corrective
and Preventive
action)
Complaint
Site Manager Quality assurance

and Regulatory Affairs
Complaint Records Filed
Complaint records are maintained at the site by the site Manager Quality Assurance and
Regulatory affairs complete record contains complaint details, investigation report,
response to complainant and closure of complaint handling process.

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Schematic representation of Recall procedure:

Directive from Licensing
Authority
Voluntary Recall (Brussels)
Voluntary Recall by
contract giver
Investigation by Site QA
With Immediate
Effect
Maximum 1 Day
Approval of Recall by Director (Brussels Parenterals)
Authority for recall
Recall notification
Product Recall by the Owner
Mutual decision by marketing head
Disposal at the
owner end
Receipt of Recalled Goods by the owner

Disposal
With Immediate
Effect
Only if dead line fixed by the licensing
Review & Comments on Investigation report by corporate

technical team
Reconciliation of the recalled goods
Prior information of disposal for

domestic recalls to the licensing
authority
Disposal
Disposal details to the

Recall t accepter
Summary report by the site QA

manager

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13.0 Self Inspection System

Short description of the self-inspection system
The purpose of Self Inspection is:
- To evaluate and monitor the implementation of WHO-GMP on all aspects of production and
quality control including support departments e.g. Maintenance, PPIC and Warehouse,
Product Development, General Affair/ Personnel Department and Purchasing.
- To detect weakness and deficiencies in the production and quality control procedures and
operations.
- To recommend necessary measures.
Audit is implemented by a competent team (which is understand the rule/ stipulation in WHOGMP/PIC/TGA and having experience of applying SOP in their own department). The member
should not be the ones who poses vested interest and they should not also holding any kind of
responsibility that related to the audited department. The chairman should be selected from
other department than the audited department.
QA/QC Manager coordinates audit implementation and forms audit panel team that consists
of delegated personnel from:
- Quality Control/ Quality Assurance department
- Production department
- Product development department
- Maintenance/ Engineering department
- GA / Personnel department
- PPIC and Warehouse department.
The Self-Inspection activities are:
- The auditors prepare the Self- Inspection Program planning.
- The auditors team interviews the audited staff.
- The auditors compose an audit report with a detailed list of the points for improvement or
for corrective action.
- The auditors arrange closing meeting, which are participating by responsible person for self
inspection at QA, auditor for the audit sector and appointed person from the audited
department who is holding responsible for the audit result. The meeting will appraise level
of findings and ask the appointed person for the audit result about corrective action,
complete with the time limit as well.
- Auditor for the audit sector should checks and reviews the follow up of corrective actions
taken by the audited department, with accordance to closing meeting result.

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Annexure: I
Schematic Diagram of Air Handling Unit
FILTRATION
LEVEL
10% Fresh Air
0.3
HEPA
FILTER
20
Micron
10
Micron
10 Micron
Filter at
Room
level
5 Micron
0.3
Micron
Manu
Area
VCD
5 Micron
Filter
Base Frame
Fan Section
VCD
Coil Section
VCD
Fresh
Air
10 Micron
Filter
Room level
20
Micron
Filter
VCD

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Annexure II
Schematic Diagram of Water System
Raw
Water
Storage
Tank
1000 liters
Over Head
Raw Water
Storage
Tank
5000 liters
For Daily
Miscellaneous
Use
Raw Water
Over head
Storage
Tank
500 liters
R.O. Water Plant
R.O. Water
Storage
Tank
500 liters
D.M, Water Plant

Tablet
Department
G.I.D.C. Supply
Raw Water under

Ground Storage
Tank
10000 liters
D. M. Water
Storage
Tank
2000 liters
Q.C.
Laboratory
Liquid
Department

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Annexure: III
LIST OF MACHINARY IN PRODUCTION DEPARTMENT
NON BETA- LACTUM
(A) RAW MATERIAL ROOM

Sr.No
1
2
3
4
Name of Machine
Weigh Balance 200Kg
Laminar air flow
Weigh Balance 1 Kg
Weigh Balance 500Kg
Capacity
200 kg
------1 kg
1 kg
(B)PRODUCTION EQUIPMENT LIST (TABLET DEPARTMENT)

Sr. No
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Equipment Name
SIFTER
RAPID MIXED / GRANULATOR
OCTAGONAL BLENDER
FLUID BED DRIER
20 STATION SINGLE ROTARY MACHINE
35 STATION DOUBLE ROTARY MACHINE
DUST COLLECTOR
DE-DUSTER-I
DE-DUSTER-II
DEHUMIDIFIER
COATING PAN WITH MACHINE
HOT AIR BLOWER WITH MACHINE
SPRAY GUN
POLISHING PAN
EXHAUST
ANALYTICAL BALANCE
FRIABILITY APPARATUS
VERNIER CALIPER
HARDNESS TEST APPARATUS
DISINTEGRATION TEST APPARATUS
Capacity
30 kg
60 kg
150 kg
60 kg
26400 / hrs.
85000 / hrs.
------------------40 kg
-----7.8 liter
40 kg
----100 gm
---------------------

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(C) PRODUCTION EQUIPMENT LIST (CAPSULE DEPARTMENT)
Sr. No
Equipment Name
Capacity
SIFTER
30 kg
DOUBLE CONE BLENDER
25 kg
HAND FILLING MACHINE -I
50000 caps./ shift
HAND FILLING MACHINE II
50000 caps./ shift
SEMI AUTOMATIC CAPFILL MACHINE
300000 caps/shift
(D) Packaging Section

Sr.No
1
2
Name of Machine
BLISTER
STRIPPING
Capacity
100000/ hrs
50000/ hrs
(E) PRODUCTION EQUIPMENT LIST (LIQUID DEPARTMENT)

Sr. No
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
Equipment Name
SUGAR SYRUP PREPARATION TANK WITH STIRRER
FILTRATION UNIT
100 LITTER TANK WITH STIRRER
300 LITTER TANK
500 LITTER TANK WITH STIRRER
1200 LITTER TANK
1200 LITTER WITH STIRRER
COLLOID MILL
TWO HEAD SEMI AUTO FILLING MACHINE
TWO HEAD SEMI AUTO FILLING MACHINE
6 HEAD AUTOMATIC FILLING /SEALING MACHINE
ROPP CAP SEALING MACHINE (MANUALLY )
ROPP CAP SEALING MACHINE (AUTO )
200 LITTER TANK
CODDING AND LABELING MACHINE
600 LITTER TANK
Capacity
500 liters
500 liters/Hr
100 liters
300 liters
500 liters
1200 liters
1200 liters
300 liters/Hr
2500 Bottles/Hr
2500 Bottles/Hr
8000 Bottles/Hr
2500 Bottles/Hr
8000 Bottles/Hr
200 liters
5000 Bottles/Hr
600 liters

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BRUSSELS LABORATORIES PVT. LTD.

LIST OF MACHINARY IN PRODUCTION DEPARTMENT
BETA- LACTUM
(E) RAW MATERIAL ROOM
SR. NO
1
2
3
4
4
EQUIPMENT NAME
WEIGH BALANCE
LAMINAR AIR FLOW
WEIGH BALANCE
WEIGH BALANCE
WEIGH BALANCE
CAPACITY
300 KG
-----1 KG
200 KG
300 KG
(F) PRODUCTION EQUIPMENT LIST (BOND STORAGE AREA)

SR. NO
1
EQUIPMENT NAME
STRAPPING MACHINE
CAPACITY
200 Units/Hr
(G) GRANULATION DEPARTMENTS

SR.NO
1
2
3
4
5
NAME OF MACHINE
CONE BLANDER 25KG
MASS MIXER 50KG
DEHUMIDIFIRE
TRAY DRYIER 24 TRAY
MULTI MILL WITH 1 SHIVE
CAPACITY
25 KG
50 KG
-----40 Trays
25 Kg/Hrs
(H) COMPRESSION SECTION

SR. NO
1
NAME OF MACHINE
16 STA. ROTARY MACHINE (TABLET)
CAPACITY
24000TAB / Hrs
(I) COATING ROOM

SR. NO
1
2
3
NAME OF MACHINE
BLOWER WITH HEATER
COATING PAN 36
SPRAY GUN ASSEMBLY 1 Lit
CAPACITY
------25 KG
1 Liter

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(J) PACKING ROOM

SR. NO
EQUIPMENT NAME
1
3
4
BLISTER
ALU -ALU
DE HUMIDIFIER
5
6
S.A. CARTON CODING MACHINE

MANUAL CARTON CODING MACHINE
CAPACITY
-------------500 Labels/Hrs
MANUALS
(K) I.P. Q.C

Sr.No
1
2
3
4
Name of Machine
BULK DENSITY APPARATUS
DIGITAL FRIABILITY TEST APPARATUS
TABLET DISINTEGRATION MACHINE
WEIGH BALANCE 200 GM
Capacity
--------------200 GM
(L) CAPSULE / DRY SYRUP

Sr.No
1
2
3
4
Name of Machine
DRY SYRUP FILLING M/C
DOUBLE CONE BLENDER
CAP SEALING M/C
DE HUMIDIFIER
Capacity
1000 Bottles/Hr
25.00 KG
1500 Bottles/Hr
--------
(M) GENERAL PACKING ROOM

Sr.No
1
2
3
Name of Machine
LABLE CODDING MACHINE
LABLE CODDING MACHINE (SEMI AUTOMETIC)
WEIGHING BALANCE - 1KG
Capacity
2500 / hrs
1000 /hrs
1.00 kg

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BRUSSELS LABORATORIES PVT. LTD. LIST OF LABORATIORIES INSRUMENT

SR. NO
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
NAME OF EQUIPMENT
U.v vis.spectrophotometer
Melting point apparatus
Digital pH meter
Vaccum ovan
Friability test apparataus
Polarimeter sipcon optical ind
Disintegration test apparataus
Tablet dissolution test apparatus
Karl fisherbtitrationapparatus
Refractometer rajdhani scient.ind
Singal pan balance(electrical)
Tablet hardness test apparatus
Karl fisherbtitrationapparatus
Infra red moisture balance
Hot air oven
Ultrasonics Apparatus
Autoclave lab model
Centrifuge apparatus
Microscope set
Hot plate
Colony counter
Laminar flow bench 4 feet
Refrigerator 350 loit
HIGH PERFORMANCE LIQUID CHROMATOGRAPH (HPLC)
MUFFEL FURNACE
VERNIER CALIPERS MITUTOYO
WATERBATH WIH THERMOSTATE CONTROL
AUTO TITRATER POTATIOMETER
CONDUCTIVITY METER
THIN LAYER CHROMATOGRAPHIC APPARATUS
BULK DENSITY APPARATUS
DESSICATOR
VACCUM DESSICATOR
SIEVE ANALYSIS SET
MAKE
Systonic
Kumar
Systronic
Kumar
D. B.K
Sipcon
D .B.K
Electrolab
Systronic
Rajdhani
DHONA
Cadmach
Systronic
Sipcon
Kumar
Enertech
Labtornic
Remi
Alancro
Kumar
D.b.k
Labtronic
Electrolux
ANALYTICAL
KUMAR
ACROSPED
KUMAR
SYSTRONICS
SYSTRONICS
KUMAR
D.B.K.
BOROSIL
BOROSIL
------
VISCOMETER SARTORIOUS
DISTILAION SET MADE OF S.S.
HEATING MENTAL APPARATUS
MAGNETIC STIRRER WITH HOT PLATE
UV-CABINET
BOROSIL
LABTRONIC
KUMAR
RAMI
KUMAR

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Annexure: IV
FLOW CHART- RM/PM INSPECTION
PACKING MATERIALS
RAW MATERIAL
RECIEPT
VERIFICATION
SAMPLING
UNDER TEST
Q.C. TESTING
REJECTED
APPROVED
RETURN TO THE
SUPLLIER /
DESTRUCTION
FOR MANUFACTURING

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Annexure: V
FLOW CHART-INPROCESS INSPECTION
RECEIVED INPROCESS REQUISTION ALONG WITH SAMPLE
TESTING AS PER SPECIFICATION OR REQUISITION
RESULT CONVEYED TO PRODUCTION

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ANEXURE: VI
Flow Diagram of the Process of Tablet Manufacturing:
Dispensing of R.M.
Shifting
Dry Mixing
Binder Preparation
Wet Mixing
Milling
Drying
Granulation
Lubricants
Lubrication
Granuls Weighing
Dedusting
Compression
Visual Inspection
Coating
Dispensing of packing material
Blistering
Q.A. / Q.C. Release
Packing
Despatch

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Flow Diagram of the Process of Capsule Manufacturing:
Dispensing of R.M.
Shifting
Drying
Moisture Analysis
Weighing
Bulk Analysis
Filling & Sealing
Blistering
Packing
Despatch

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Flow Diagram of the Process of Liquid Manufacturing:
Dispensing of RM
DM Water Plant
Fresh Purified Water I.P.
Sugar Syrup Heat to
80 - 90 C
(Steam Jacketed)
Manufacturing of
Solution
Empty Bottles
Washing of Bottles
by Rotary Machine
Bulk Analysis by Q.C.
Strain through 40 no. mesh S.S. Sieve

then colloiding of total bulk solution
Bottle filling & sealing
Visual Inspection
Dispensing of PM
Labelling & Packing
Q.C. / Q.A / Production
Documentation Review
Despatch

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Flow Diagram of the Process of Dry Syrup Manufacturing:
Dispensing of R.M.
Shifting
Mixing
Drying
Moisture Analysis
Weighing
Bulk Analysis
Filling & Sealing
Despatch
Packing

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Anexure: VII
FLOW CHART- FINISHED PRODUCT INSPECTION
RECEIVED INPROCESS REQUISTION ALONG WITH SAMPLE
TESTING AS PER SPECIFICATION OR REQUISITION
RESULT CONVEYED TO PRODUCTION

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Anexure: VIII
Manufacturing License in Form No.28

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: GMP Certificate:

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Annexure: X : WHO Certificate:

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Annexure: XI
NON BETA LACTAM SYRUP/SUSPENSION/DROPS

Sr.
No
Brand Name of the

Products
Generic Name & Strength of the Products
LMD - AX SYRUP
Ambroxol Hcl & Levocetirizine Hcl Syrup
LEVORICH-AX SYRUP
Ambroxol Hcl & Levocetirizine Hcl Syrup
AMBRONIC PLUS SYRUP
Ambroxol Hcl, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup
SAFEX-BR SYRUP
SAINOCOF SYRUP
ALTO-X SYRUP
AROMET - XN SYRUP
LANZA SYRUP
NOSPIN SYRUP
10
AMBRODEL SYRUP
11
SUGOF SYRUP
Ambroxol Hcl, Terbutaline Sulphate & Guaiphenesin Syrup
12
RECOLD SYRUP
13
XPEROX SYRUP
14
RESPINIL SYRUP
15
TUFEX SYRUP
16
ZYTUS - A SYRUP
17
KUFRID SYRUP
Bromhexine Hcl, Dextromethorphan Hbr, Ammonium Chloride & Menthol Syrup
18
EDEX COUGH SYRUP
Bromhexine Hcl, Dextromethorphan Hbr, Ammonium Chloride & Menthol Syrup
19
THEOCOF SYRUP
Bronchodilator Syrup
20
CETBRO SYRUP
Cetirizine Hydrochloride & Ambroxol Hydrochloride Syrup
21
ACODIN SYRUP
Codeine Phosphate & Chlorpheniramine Maleate Syrup
22
BRUCODIN SYRUP
Codeine Phosphate & Chlorpheniramine Maleate Syrup
23
B-CODIN SYRUP
Codeine Phosphate Syrup I.P
24
CYPROLIN SYRUP
Cyproheptadine Hcl, Tricholine Citrate & Sorbitol Solution
25
CIPRON SYRUP
Cyproheptadine Hydrochloride Syrup I.P.
26
CIPRON DROPS
Cyproheptadine Hcl & Tricholine Citrate Drops
27
SINODEX SYRUP
Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Chlorpheniramine Maleate & Menthol Syrup
28
DYLATE - DX SYRUP
Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride & Chlorpheniramine Maleate Syrup

SITE MASTER FILE
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 65 of 81
29
MOCOF SYRUP
30
YOYO-DX
31
X-COF-PLUS SYRUP
Dextromethorphan Hydrobromide, Chlorpheniramine Maleate & Phenylephrine Hydrochloride Syrup
32
XPEROX DM SYRUP
33
DEXOFAST PLUS SYRUP
34
COFIUM D SYRUP
35
RESPINIL - D SYRUP
36
ZYTUS SYRUP
Dextromethorphan Hydrobromide & Chlorpheniramine Maleate Syrup
37
TEKOF SYRUP
Dextromethorphan Hydrobromide & Chlorpheniramine Maleate Syrup
38
GEFDEX - D SYRUP
39
SNIZGO - D SYRUP
40
PEUTREX - Dx SYRUP
41
BRUDRYL EXPECTORANT
Diphenhydramine Hcl, Ammonium Chloride, Sodium Citrate & Menthol Syrup
42
SUPERDRYL SYRUP
Diphenhydramine Hcl, Ammonium Chloride, Sodium Citrate & Menthol Syrup
43
AROLKA LIQUID
Disodium Hydrogen Citrate Syrup
44
COLDNEM SYRUP
Guaiphenesin, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride & Chlorpheniramine Maleate Syrup
45
ACTILEX
Lactulose Solution U.S.P.
46
CLANUS
Lactulose Solution U.S.P.
47
LECENTA SYRUP
Levocetirizine Syrup
48
SETTLE ORAL SOLUTION
Ondansetron Oral Solution USP
49
EMYRA SYRUP
Ondansetron Oral Solution I.P.
50
AXISET SOLUTION
51
ONSTOP SOLUTION
52
VOMIDEL SYRUP

SITE MASTER FILE
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 66 of 81
53
EMDONE SYRUP
54
SAINOCOLD SYRUP
Paracetamol, Phenylephrine Hcl & Chlorpheniramine Maleate Syrup
55
METACOLD
56
ACOLATE KID SYRUP
57
ALTOZYME SYRUP
Digestive Enzymes Liquid
58
NICZYME SYRUP
Pepsin with Diastase Liquid
59
DELZYME SYRUP
60
NEMZYME SYRUP
61
ANZYME SYRUP
62
PEPZYME SYRUP
63
PEPSTAZ SYRUP
64
ABCURE
Potassium Citrate and Citric Acid Oral Solution U.S.P.
65
BRUMOLATE SYRUP
Paracetamol, Phenylephrine Hcl, Chlorpheniramine Maleate & Bromhexine Hcl Syrup
66
RECONITE SYRUP
Paracetamol, Phenylephrine Hcl, Chlorpheniramine Maleate & Bromhexine Hcl Syrup
67
ZYTUS - BX SYRUP
Terbutaline Sulphate, Bromhexine Hcl, Guaiphenesin & Menthol Syrup
68
TERNEST - BG SYRUP
69
SYNOZYME SYRUP
70
TICOF SYRUP
71
PEUTREX - Ex SYRUP
72
ELECOF SYRUP
Terbutaline, Bromhexine, Guaiphenesin & Menthol Syrup
73
KOFXTA-BX
EXPECTORANT
Terbutaline, Bromhexine & Guaiphenesin Expectorant
74
SNIZGO SYRUP
Terbutaline, Bromhexine & Guaiphenesin Syrup
75
CYTRILIV SYRUP
Tricholine Citrate & Cyproheptadine Hcl Syrup
76
CYPONIC SYRUP
77
SAIPRO-L
78
HEPACYT SYRUP
79
CIPRON PLUS SYRUP
80
SYPOL SYRUP
81
SORLIV - TS SOLUTION
Tricholine Citrate & Sorbitol Solution
82
ICELIV SOLUTION
83
LIVOLINE SOLUTION
84
AX-WORM SUSPENSION
Albendazole Oral Suspension U.S.P.
85
DEWORM SUSPENSION

SITE MASTER FILE
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 67 of 81
86
STAR NILWORM SUSP
87
ALBEN - S SUSPENSION
88
89
ONICID GEL
Alumina, Magnesia & Simethicone Oral Suspension U.S.P.
90
ULCILES GEL
91
GASTINIL MPS
92
PILOT GEL
93
GASTISOL SUSPENSION
Alumina, Magnesia, and Simethicone Oral Suspension U.S.P.
94
ACMOX DRY SYRUP
Amoxycillin Oral Suspension I.P.
95
MOXITOP DRY SYRUP
96
ZILOX DRY SYRUP
97
MOXSIM DRY SYRUP
98
LENOCARB SUSPENSION
Antacid, Antiflatulent, Adsorbent Suspensioin
99
LENOCARB - M
SUSPENSION
Magaldrate & Simethicone Oral Suspension U.S.P.
100
LENOCARB-M PLUS
SUSPENSION
Antacid, Antiflatulent, Adsorbent Suspensioin
101
PACK-UP SUSPENSION
Chlorpheniramine Maleate Dextromethorphan, Paracetamol & Phenylephrine Hcl Suspension
102
PACK-UP SUSPENSION
Chlorpheniramine Maleate Dextromethorphan, Paracetamol & Phenylephrine Hcl Suspension
103
STAR TRIM SUSPENSION
Co-Trimoxazole Oral Suspension B.P.
104
VINCO
Dried Aluminium Hydroxide Gel, Magnesium Hydroxide, Activated Polydimethylsiloxane & Domperidone Suspension
105
BRUCID
Dried Aluminium Hydroxide Gel, Magnesium Hydroxide & Simethicone Suspension
106
OFCID SUSPENSION
Magaldrate with Simethicone Oral Suspension U.S.P.
107
CID LIQUID
MAGALDRATE & Simethicone Oral Suspension U.S.P.
108
TEKCID SUSPENSION
Magaldrate, Activated Simethicone & Domperidone Suspension
109
NEEDFAST-PD
SUSPENSION
Nimesulide & Paracetamol Suspension
110
NIMBEL - P SUSPENSION
111
KEYNIM - P SUSPENSION
112
NIPAR SUSPENSION
113
NEEDFAST SUSPENSION
Nimesulide Suspension
114
KEYNIM SUSPENSION
Nimesulide Suspension

SITE MASTER FILE
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 68 of 81
115
ACOFLOX SUSPENSION
Ofloxacin Suspension
116
OFDIP SUSPENSION
Ofloxacin Suspension
117
METACID SUSPENSION
Oxetacaine, Aluminium Hydroxide & Magnesium Hydroxide Suspension
119
ACMOL - 250
SUSPENSION
Paracetamol Oral Suspension B.P.
120
S-MOL-DS SUSPENSION
121
BELPAR - 250
SUSPENSION
122
PARK SUSPENSION
123
MOL-98 SUSPENSION
Paracetamol Oral Suspension B.P
124
OPERA 250
Paracetamol Oral Suspension B.P.250 mg.
125
PARADEX SUSPENSION
126
TYNOL SUSPENSION
127
BELPAR - 125
SUSPENSION
128
OPERA 125
Paracetamol Oral Suspension B.P.125mg.
129
S - MOL SUSPENSION
130
ALIVIO - S SUSPENSION
Paracetamol Oral Suspension B.P. 125 mg.
131
NORMAGAN SUSPENSION
Paracetamol & Promethazine Hcl Suspension
132
BRUCID SUSPENSION
Dried Aluminium Hydroxide Gel, Magnesium Hydroxide & Simethicone Suspension
133
HEMOX FORT GEL
Antacid suspension

SITE MASTER FILE
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 69 of 81
NON BETA LACTAM TABLETS

Sr.No
1
Brand Name of the Products

STARMOL TABLET

Paracetamol Tablets B.P. 500 mg.
ANEED TABLET
Aceclofenac Tablets I.P 100 mg.
SITRAMON- SHIFO TABLETS
acetaminophen , aspirin and caffeine tablets u.s.p
MONOTIL - 400 TABLET
Albendazole Chewable Tablets
MONOTIL - 200 TABLET
ALZOLE 400
STAR NILWORM 400
Albendazole Tablets
Amiloride Hydrochloride & Hydrochlorothiazide Tablets U.S.P .
Amitriptyline Tabets B.P. 25 mg.
10
Amitriptyline Tabets B.P. 10 mg.
11
ECOTOR-40 TABLETS
atorvastatin calcium tablet ip
12
LIPIDEC TABLET
Atorvastatin Calcium Tablets I.P. 10 mg.
13
ATO 8
Betahistine Dihydrochloride Tablets B.P. 8 mg.
14
Betaro 8
Betahistine Hydrochloride Tablets I.P 8 mg.
15
Revertin 16
16
Betaro 16
17
Revertin 8
18
CARBAZINE TABLETS
CARBAMAZEPINE TABLETS BP. 200 MG
19
CARBASOL
CARBAMAZEPINE TABLETS BP. 200 MG
20
BRUCET
Cetirizine Tablets 10 mg.
21
CPM
Chlorpheniramine Maleate Tablets USP 4mg
22
CPM-4
23
24
EMTIDINE 200
Cimetidine Tablets B.P. 200 mg.
25
EMTIDINE - 400
Cimetidine Tablets B.P. 400 mg.
26
OMNICIP-TZ TABLETS
ciprofloxacin & tinidazole tablets
27
HARCIPRO - 250 TABLET
Ciprofloxacin Tablets B.P. 250 mg.
28
CEEPOO - 250 TABLET
Ciprofloxacin Tablets I.P. 250 mg.
29
CANZO-500 TABLETS
30
HARCIPRO - 500 TABLET
31
SIPRO - 500 TABLET
32
BRUCIP 500
33
BRUCIP 500

SITE MASTER FILE
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 70 of 81
34
OMNICIP-500 TABLETS
CIPROFLOXACIN TABLET IP 500 MG
35
SLAN - CIP TABLET
36
CEEPOO - 500 TABLET
37
PREL
Clopidogrel Tablets USP 75 mg.
38
CPC - CLOPIDOGREL 75 MG
Clopidogrel Tablets USP 75 mg.
39
CANADEL - 100 TABLET
Clotrimazole Vaginal Tablets 100 mg
40
GASTISOL TABLET
Compound Magnesium Trisilicate Tablet B.P.
41
STARTRIM 480
Co-Trimoxazole Tablets B.P.
42
MEDTRIM TABLET
Co-Trimoxazole Tablets B.P. 480 mg.
43
COTRIM TABLET
Co-Trimoxazole Tablets B.P. 480 mg.
44
COTRIM TABLET
Co-Trimoxazole Tablets I.P. 480 mg.
45
CYPROHAR - 4 TABLET
Cyproheptadine Tablets B.P. 4 mg.
46
SEAZAPAIN
Diclofenac Potassium Tablets 50 mg.
47
NELAC - 50 TABLET
Diclofenac Sodium Tablets 50 mg.
48
STARNAC 50
49
BRUNAC 50
50
DICLOMED TABLET
51
BRUNAC 100
Slow Diclofenac Tablet B.P.
52
STARNAC 100
53
STARNAC 100
54
DOXEN
Doxofylline Tablets 400 mg.
55
ORDOX
Doxylamine Succinate,Pyridoxine Hydrochloride & Folic Acid Tablet
56
EMEPURE TABLETS
Doxylamine Succinate, Pyridoxine Hydrochloride & Folic Acid Tablets
57
DOXIDEL PLUS TABLET
Doxylamine Succinate, Pyridoxine Hydrochloride & Folic Acid Tablet
58
GNUS TABLET
Doxylamine Succinate, Pyridoxine Hydrochloride & Folic Acid Tablet
59
ESTHROCIN 250
Erythromycin Stearate Tablets B.P. 250 mg.
60
ESTHROCIN 500
61
EMZOR GRISEOFULVIN
Griseofulvin Tablets B.P. 500 mg.
62
GATYX -400 TABLETS
GATIFLOXACIN TABLETS I.P 400 MG.
63
VISHANTRIN TABLET
Halofantrine Hydrochloride Tablets
64
Hydrochlorothiazide Tablets BP 50 mg
65
BRUFLAM - 200 TABLET
Ibuprofen Tablets B.P. 200 mg.
66
STAR FLAM 200
67
IBUMED - 200 TABLET
68
HARIBU - 400 TABLET

SITE MASTER FILE
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 71 of 81
69
STAR FLAM 400
70
BRUFLAM 400
71
TENOCAM
72
IBUMED - 400 TABLET
73
Indometacin Tablets BP 25 mg
74
UVR - 10 TABLET
Isoxsuprine Tablets I.P. 10 mg.
75
UVR - 20 TABLET
Isoxsuprine Tablets I.P. 20 mg.
76
ISOR-SR TABLETS
Isoxsuprine Sustained Release Tablets 40 mg.
77
UVR SR TABLET
78
ISODEL - 40 SR TABLET
79
LZ-5 TABLETS
LEVOCETRIZINE TABLETS IP 5 MG
80
BLEVO-250 TABLET
Levofloxacin Tablets I.P. 250 mg.
81
ROLEVO - 250 TABLET
82
LV-DCARE-250 TABLET
83
LEVORAM - 250 TABLET
84
L-QUIN-250 TABLET
85
VOLMED-250 TABLET
86
LEVOSTAR TABLET
Levofloxacin Tablets 500 mg.
87
BLEVO-500 TABLET
88
ROLEVO-500 TABLET
89
VEYRON - 500 TABLET
90
LV-DCARE - 500 TABLET
91
LEVORAM-500 TABLET
92
TEKFLOX- 500 TABLET
93
LEVCURE- 500 TABLET
94
L-QUIN- 500 TABLET
95
VEYRON - 750 TABLET
96
LINOZA 600 TABLET
Linezolid Tablets I.P.
97
LINVIN 600 TABLET
Linezolid Tablets I.P.
98
Losartan Potassium Tablets 50 mg.
99
Losatan Potassium Tablets 50 mg.
100
TEMCID M TABLET
Mefenamic Acid & Tranexamic Acid Tablets
101
Metformine Hydrochloride Extended Release Tablets U.S.P.
102
METRO - 200 TABLET
metronidazole Tablets B.P. 200 mg.
103
METRO - 200 TABLET
metronidazole Tablets B.P. 200 mg.

SITE MASTER FILE
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 72 of 81
104
Metformin Tablets B.P. 500 mg.
105
HARNIME - 100 TABLET
Nimesulide Tablets 100 mg.
106
SAINOSPAS TABLETS
Nimesulide & Dicyclomine Hydrochloride Tablets
107
SAINOCOLD+ TABLETS
Nimesulide, Phenylpropanolamine HCL, CPM & Caffeine Tablets
108
N-FLOX-400 TABLET
Norfloxacin Tablets B.P 400 mg
109
BRUFLOX-400
Norfloxacin Tablets 400 mg
110
ELEFLOX - 200 TABLET
Ofloxacin Tablets I.P. 200 mg.
111
OFLAMET - 200 TABLET
112
SAIFLOX - 200 TABLET
113
O-QUIN - 200 TABLET
114
FLOMED - 200 TABLET
115
ELEFLOX - OZ TABLET
Ofloxacin & Ornidazole Tablets
116
ORNOCIN - OZ TABLET
117
ROFLOX - OZ TABLET
118
OFLOWON-OZ TABLET
119
OFLOXIN- OZ TABLET
120
O-QUIN - OZ TABLET
121
OFLEE - OZ TABLET
122
ELEFLOX - 200 TABLET
123
OFLAMET - 200 TABLET
124
SAIFLOX-200 TABLET
OFLOXACIN TABLETS I.P. 200 MG
125
O-QUIN-200 TABLET
126
FLOMED-200 TABLET
127
ONSTOP - MD TABLET
Ondansetron Orally Disintegrating Tablets I.P.
128
EMYRA MD TABLET
129
VOMREST TABLET
130
MEDRON MD TABLET
131
ONSTOP-MD
Ondansetron Tablets B.P 4mg.
132
EMERIL TABLET
133
PENTEK-40 TABLET
Pantoprazole Sodium Tablets I.P. 40 MG
134
ROPENTA-40 TABLET
135
PANOR-40 TABLET
136
PANTOJAC-40 TABLET
137
SAIPAN-40 TABLET

SITE MASTER FILE
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 73 of 81
138
OXYPAN-40 TABLET
139
PENTAPURE-40 TABLET
140
BRUPENTA-40 TABLET
141
ASTHAPAN-40 TABLET
142
APRILIA TABLET
Pantoprazole Tablets 40 MG
143
PILOT D
Pantoprazole & Domperidone Tablets
144
ROPENTA - D TABLET
145
PANOR - D TABLET
146
SAIPAN-D TABLETS
147
OXYPAN-D TABLETS
148
PULCID D TABLET
149
BRUPENTA - D TABLET
150
ASTHAPAN - D TABLET
151
PANTO - D
152
Paracetamol Tablet BP 500 mg
153
HARPARA TABLET
154
STARMOL TABLET
155
BRUMOL TABLET
Parcetamol Tablets B.P. 500 mg
156
YOYO - 500 TABLET
Paracetamol Tablets I.P. 500 mg.
157
YOYO - 650 TABLET
158
TEKPAR - 650 TABLET
159
SPEEDOL 650 TABLET
160
Prednisolone Tablets B.P. 5 mg
161
PREDIZA TABLET
Prednisolone Tablets B.P. 5 mg
162
Propranolol Tablets BP 40 mg
163
RABIJAC-20 TABLETS
RABEPRAZOLE SODIUM TABLETS IP 20 MG
164
RABICON-20 TABLETS
RABEPRAZOLE SODIUM TABLETS IP 20 MG
165
HUGE - 20 TABLET
Rabeprazole Sodium Tablets I.P. 20 mg.
166
RABICON - D TABLET
Rabeprazole & Domperidone Tablets
167
R - SLAN TABLET
Ranitidine Tablets I.P. 150 mg.
168
SACZAD-DS
secnidazole tablets . 1 gm
169
TRAMAGRA TABLET
Sildenafil Citrate & Tramadol Tablets
170
PARTNER-X
sildenafil citrate tablets 50 mg
171
BRUNAC 100
Slow Diclofenac Tablet B.P.
172
Sodium Valproate Tablets BP 200 mg

SITE MASTER FILE
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 74 of 81
173
SPIRAM TABLETS
Spirmaycin Tablets 3 M.I.U
174
RUN
TADALAFIL TABLETS
175
Terbutaline Tablets B.P. 2.5 mg.
176
TINIZAD-500
TINIDAZOLE TABLETS. 500 MG
177
DYRIL PLUS TABLETS
Tinidazole & Diloxanide Furoate & Polydimethylsiloxane Tablets
178
TIMIC VAGINAL TABLETS
Tinidazole, Miconazole Nitrate & Clotrimazole Vaginal Tablets
179
COMIT
180
DOCE 20
181
AURADOL DT
Tramadol Dispersible Tablets
182
AURADOL P
Tramadol Hydrochloride & Paracetamol Tablets
183
ZEROCET TABLET
184
TDOL - P TABLET
185
XYROCET TABLET
186
TDOL-P TABLETS
TRAMADOL & PARACETAMOL TABLETS
187
TEMCID TABLET
Tranexamic Acid Tablets
188
TRIFED TABLETS
Triplodine Hydrochloride, Pseudoephedrine Hydrochloride Tablets
189
TRIFED PLUS TABLETS
190
EMERIL TABLET
Triplodine HCL,Pseudoephedrine Hydrochloride & Paracetamol

Tablets
191
Atorvastatin Tablets I.P. 10 mg.
192
Atorvastatin Tablets I.P. 20 mg.
193
TEKPAR RAPID - 500 TABLET
194
ANEED - P TABLET
Aceclofenac & Paracetamol Tablets
195
TEKPAR - A TABLET
196
ATRACK - P TABLET
197
BRUNAC - P
Diclofenac Potassium & Paracetamol Tablets
198
HARDICLO - P - 500 TABLET
Diclofenac Sodium & Paracetamol Tablets
199
DICLO PLUS FORTE
200
DOLO RELIEVE
209
ALIDEX TABLET
Dexchlorpheniramine Maleate Tablet U.S.P
210
ENTROLAC TABLET
Lactic Acid Bacillus Tablets
211
ALIVIO TABLET
Paracetamol Tablets B.P 500 mg.
212
MEDLONE TABLET
Prednisolone Tablets B.P 5 mg.
213
TEKPAR RAPID-500 TABLET
Paracetamol Tablets I.P 500 mg.

SITE MASTER FILE
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 75 of 81
NON BETA LACTAM CAPSULES

Sr.No
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
FANI - 250 CAPSULE

PULCID DSR CAPSULE
PANTEK DSR CAPSULE
PILOT - DSR CAPSULE
OGBU - DSR CAPSULE
PACIDOM - SR CAPSULE
RABIDOM - SR CAPSULE
RABELAN - DSR CAPSULE
RABICON-DSR CAPSULE
R - DOM 50 CAPSULE
HUGE - D CAPSULE
RABIZA DSR CAPSULE
INDOCAM 25
LOPEX CAPSULE
LOMEX
OMICAM 20
PRACID-20 CAPSULE
PIROX - 20 CAPSULE
TETRA - 250
SAMPLEX
SEADONE TRAMADOL 50
SEADONE TRAMADOL 100

Chloramphenicol Capsules B.P. 250 mg.
Enteric Coated Pantoprazole and Domperidone SR Capsule
Enteric Coated Rabeprazole Sodium and Domperidone SR Capsules
Indometacin Capsules B.P. 25 mg.
Loperamide Hydrochloride Capsule USP 2 mg.
Loperamide Hydrochloride Capsule USP 2 mg.
Omeprazole Capsules 20 mg.
Omeprazole Capsules I.P. 20 mg.
Piroxicam Capsule B.P. 20 mg.
Tetracycline Capsules B.P. 250 mg.
Tramadol Capsules B.P. 100 mg.

SITE MASTER FILE
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 76 of 81
BETA LACTAM TABLET

1
2
3
4
5
6
7
8
9
10
11
12

AZIRAM - KID TABLET
THREOMYCIN 500
AZIRAM - 250 TABLET
AZIDARSH - 250 TABLET
AZ-DCARE - 250 TABLET
MAZITH - 250 TABLET
ANGITH 250
AZIRAM - 500 TABLET
AZ-DCARE - 500 TABLET
AZIROK - 500 TABLET
MAZITH - 500 TABLET
ANGITH 500

Azithromycin Dispersible Tablets 100 mg.
Azithromycin Tablets
Azithromycin Tablets I.P. 250 mg.
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
CALTEK PRO TABLET

JCAL - D TABLET
BONE - D TABLET
DBGLOB Z
FOLIMED - Z TABLET
FOLIMED TABLET
FOLUP TABLET
AZITIVE 500 TABLET
OSTEOPURE TABLET
CAL-P TABLET
ORAL
OMFER TABLETS
FERRICOMB
IMPERIAL-FE TABLETS
SLAFOLIC
ROXEL-150 TABLETS
SANCLAV TABLET
REDROX - 500 TABLET
HARDROXY - 250 TABLET
HARDROXY - 500 TABLET
Calcium Citrate & Vitamin D3 with Magnesium, Zinc & Mineral Tablets
Calcium with Cholecalciferol Tablets B.P.
Ferrous Fumarate, Folic Acid & Zinc Sulphate Tablets
Folic Acid Tablets B.P. 5 mg.
Folic Acid Tablets I.P. 5 mg.
CALCIUM CITRATE, MAGNESIUM, ZINC AND VITAMIN D3 TABLET
Folic Acid Tablets I.P. 5 mg.
Roxithromycin Tablet I.P 150 mg.
Amoxicillin and Clavulanate Potassium Tablets USP
Cefadroxil Tablets I.P. 500 mg.
Sr.No

SITE MASTER FILE
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
BRUCEF - 200 TABLET

ANAFIX - 200 TABLET
CEFREE 200 TABLET
ESSCEF 200 TABLET
ROHCEF 200 TABLET
CIFIWAT 200 TABLET
FIXIB 100 DT TABLET
FIXIB 200 DT TABLET
CEFMED - 200 TABLET
BRUCEF - 100 TABLET
ANAFIX - 100 TABLET
CEFREE 100 DT TABLET
CEFIZA - 100 TABLET
AVIATOR - 100 TABLET
CEFAMI - 100 DT TABLET
CEFIF - 100 TABLET
CEFGARD - 100 DT TABLET
ROHCEF TABLET
CIFSLAN - 200 TABLET
CEFGARD - 200 TABLET
AVIATOR - 200 TABLET
EPXIME - 200 TABLET
TRIFIX - 200 TABLET
VAXIM - 200 TABLET
CEFIZA - 200 TABLET
CEFEST - 100 TABLET
RIYCEFP - 100 TABLET
TEKPOD - 100 DT TABLET
IPOX 100 DT TABLET
TEKPOD - 200 TABLET
IPOX 200 DT TABLET
CEPOD - 50 TABLET
IPOX 50 DT TABLET
CEFEST - 200 TABLET
RIYCEFP - 200 TABLET
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 77 of 81
Cefixime Tablets I.P. 200 mg.

Cefixime Dispersible Tablets 100 mg.
Cefixime Tablets I.P. 200 mg. (Film Coated)
Cefpodoxime Proxetil Dispersible Tablets 100mg
Cefpodoxime Proxetil Dispersible Tablets 50 mg
Cefpodoxime Proxetil Dispersible Tablets 50 mg
Cefpodoxime Proxetil Tablets I.P. 200 mg.

SITE MASTER FILE
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
TEKPOD - 100 DT TABLET

TEKPOD - 200 TABLET
CEFU - 250 TABLET
DUCATI - 250 TABLET
CEFUROME 500
KACEPH - 250 TABLET
KACEPH - 500 TABLET
ERYTHRO - 500 TABLET
OMOX-KID TABLETS
AMOCEF 200 DT
D-XIM 200
CEFIF-200 DT
C-DOXIM 100 TABLET
C-DOXIM - 200 TABLET
THROSAFE-200 TABLETs
XIFIX
THROSAFE-100 TABLET
CEFUWAT-500 Tablet
AZIRIN 250 TABLET
AZIRIN 500 TABLET
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 78 of 81

Cefpodoxime Proxetil Tablets I.P. 200mg
Cefuroxime Axetil Tablets I.P. 250 mg.
Cefuroxime Axetil Tablets I.P. 250 mg.
Cefuroxime Axetil Tablets U.S.P. 500 mg.
Cephalexin Tablets I.P. 250 mg.
Cephalexin Tablets I.P. 500 mg.
Amoxycillin Trihydrate dispersible tablet I.P 125 MG
Cefpodoxime Proxetil Tablets 200mg
Cefixime Tablets U.S.P. 200 mg.
Cefuroxime Axetil Tablets I.P 500 mg.
Azithromycin Tablets I.P 250 mg.
Azithromycin Tablets I.P 500 mg.

SITE MASTER FILE
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 79 of 81
BETA LACTAM CAPSULES

1
2
3
4
5
6
7
Brand Name of the

Products
CARBOFAST CAPSULE
BRUTONE CAPSULE
IMPERIAL CAPSULE
HARMOXY - 500 CAPSULE
STAR MOX - 250 CAPSULE
BRUMOX - 250 CAPSULE
ZILOX 500 (4th Brand)

Carbonyl Iron, Folic Acid, Vitamin B12 & Zinc Capsules
Amoxicillin Capsules B.P. 500 mg.
Amoxycillin Capsules I.P.
8
9
10
11
12
13
14
15
16
17
18
19
20
21

STAR MOX - 500 CAPSULE
ZILOX DC
SUCLOX - DC CAPSULE
ZILOX - 500 CAPSULE
HARAMPI - 500 CAPSULE
METCLOX CAPSULE
MILOXIN CAPSULE
C-MOX CAPSULE
CEPHAN - 500 CAPSULE
OMOX 500
BRUCLOX-500 For Export

Amoxycillin & Dicloxacillin Capsules
Ampicillin Capsules B.P. 250 mg.
Cefalexin Capsules B.P. 500 mg.
Amoxycillin Capsules I.P.
Ampicillin & Cloxacillin Capsules
Sr.No

SITE MASTER FILE
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 80 of 81
BETA LACTAM SYRUP/SUSPENSION/DROPS

Sr.No
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32

AZEN
THRAZ - 100 SUSPENSION
AZITER - 100 SUSPENSION
AZIRAK - 100 SUSPENSION
AZLO - 100 SUSPENSION
AZIFA - 100 SUSPENSION
THRAZ - 200 SUSPENSION
AZIB - 200 SUSPENSION
AZITH - 200 SUSPENSION
AZIRAM - 200 SUSPENSION
AZIDARSH-200 SUSPE
AZIFA - 200 SUSPENSION
CALBIN-D SYRUP
CALJEEV SYRUP
CALOREX - D SUSPENSION
CHERRYCAL SUSPENSION
NEMICAL SUSPENSION
FRANCAL - MZ SUSPENSION
KRDROX DROPS
V-DROX DRY SYRUP
CEPHAN DRY SYRUP
CEFGARD DRY SYRUP
VAXIM DRY SYRUP
FIXIB DRY SYRUP
ROHCEF DRY SYRUP
CEFIF DRY SYRUP
CEFAMI DRY SYRUP
CEFU DRY SYRUP
KACEPH DROPS
ESTHROCIN

Azithromycin Oral Suspension USP
Azithromycin Oral Suspension I.P.
Calcium Syrup with Vitamins D3, B12 & L-Lysine
Calcium Syrup with Vitamins D3, B12 & L-Lysine
Calcium, Magnesium, Zinc & Vitamin D3 Suspension
Cefadroxil Oral Suspension I.P.
Cefalexin Oral Suspension B.P.
Cefixime Oral Suspension I.P.
Cefuroxime Axetil for Oral Suspension U.S.P.
Cephalexin Oral Suspension I.P.
Erythromycin Ethyl Succinate Oral Suspension B.P.

SITE MASTER FILE
Document Number
QA/01/01
Revision Number
01
Effective Date
01/01/12
Review Date
20/01/13
Page Number
Page 81 of 81
33
ACMETOSE SYRUP
Iron (III) Hydroxide Polymaltose Complex & Folic Acid Syrup
34
FETON-HP SYRUP
35
IOTA SYRUP
36
ANIFOL SYRUP
37
VTON - F SYRUP
Haematinic Syrup of Iron, Folic and Vitamin B12
38
IMPERIAL SYRUP
Haematinic Syrup
39
SOMPOWER
CYPROHEPTADINE WITH MULTIVITAMIN SYRUP
40
ACMOX DRY SYRUP
41
MOXITOP DRY SYRUP
42
ZILOX DRY SYRUP
43
KMOX DROPS
44
45
OXYLICS - CL DRY SYRUP

SANCLAV DRY SYRUP
Amoxicillin and Potassium Clavulanate for Oral Suspension I.P.

Amoxicillin and Clavulanate Potassium for Oral Suspension U.S.P.
46
STAR MOX DRY SYRUP
Amoxicillin Oral Suspension B.P. 125mg. / 5ml.
47
KRDROX DROPS
48
V-DROX DRY SYRUP
49
CEPHAN DRY SYRUP
Cefalexin Oral Suspension B.P.
50
CEFGARD DRY SYRUP
51
VAXIM DRY SYRUP
52
FIXIB DRY SYRUP
53
ROHCEF DRY SYRUP
54
CEFIF DRY SYRUP
55
CEFAMI DRY SYRUP
56
RESAFE DRY SYRUP
Cefpodoxime Proxetil Oral Suspension I.P.
57
CEFEST DRY SYRUP
58
C - DOXIM DRY SYRUP
59
VEPODOX DRY SYRUP
60
TEKPOD 50mg. DRY SYRUP
61
IPOX DRY SYRUP
62
KACEPH DROPS
Cephalexin Oral Suspension I.P.

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What products are manufactured by the company?

What products are manufactured by the company?

What are the qualifications of key personnel?

What are the qualifications of key personnel?

A WHO-GMP CERTIFIED COMPANY

Brussels Laboratories Pvt. Ltd.

SITE MASTER FILE

33, CHANGODAR INDUSTRIAL ESTATE,

33, CHANGODAR INDUSTRIAL ESTATE,

A WHO-GMP CERTIFIED COMPANY

Brussels Laboratories Pvt. Ltd.

Brief information in the site

Pharmaceutical manufacturing activities

Other pharmaceutical manufacturing activities

Name and Site address

Contact persons during and outside working hours

Description of the site

Number of employee working in plant

Use of out side assistance in related to manufacturing and analysis

Calibration of critical measuring, Recording and working instruments.

Non- viable counting of the new or modified facility and periodic

Quality management system

Responsibilities of the quality assurance dept.

A WHO-GMP CERTIFIED COMPANY

Brussels Laboratories Pvt. Ltd.

Qualification, Designation, Experience and responsibility of key personnel

Health requirements for personnel engaged in production

Personnel hygiene requirement and clothing

Simple plan for premises

Air handling system and details

Brief description of water system

Cleaning and sanitization of over hand tank

Maintenance and servicing of equipments

Brief description of ventilation systems

Maintenance Programmes for premises

PREMISES AND EQUIPMENT PREMISES

Qualification, validation and calibration Programme

Equipment and Instrument qualification policy

Cleaning and Sanitation

A WHO-GMP CERTIFIED COMPANY

Brussels Laboratories Pvt. Ltd.

Description of product operation

Handling of material ( R.M., PM., Bulk and finish)

Arrangement for Handling of Rejected material and products

Description of general policy of process validation

Quality control system

Loan License Manufacture and Licensee

Distribution, Customer Complaints and Product Recall

Arrangement and recording system for distribution

Arrangement for handling of components and product recalls

Schematic diagram of AHUs.

Schematic Diagram of Water System

List of Major Equipments and Instruments used in

Flow Chart- RM/PM Inspection

Flow Chart-In Process Inspection

Flow diagrams of the processes for Tablet, Capsule, Liquid

Flow Chart- Finished Product Inspection

Photocopy of Manufacturing Licenses

A WHO-GMP CERTIFIED COMPANY