Site Master File
Site Master File
Site Master File
INDEX
Section Description Page No.
C.1 General Information
C.1.1 Brief Information On Celebrity Biopharma Limited. 3
C.3.4 Special areas for the handling of highly toxic hazardous and sensitizing 29
materials
C.3.5 Description of water system including sanitation 30-32
C.3.6 Maintenance 33
C. 4 Documentation 39-41
C5 Production 4
C.5.2 Arrangement for handling of starting materials, packaging materials, bulk 41-43
and finished products.
C.5.3 Arrangements for reprocessing or rework 43
C6 Quality Control 19
C.6.1 Description of Quality Control System and of the activities of Quality 19-21
Control Department Procedures for the release of finished products
C7 Distribution, Complaints & Product Recall 21-24
C9 Self Inspection 47
C 10 List of Annexures 27
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0. 1 GENERAL INFORMATION
C. 1. 1. Brief Information on Celebrity Biopharma Limited:
Celebrity Biopharma Limited is established in the year 2007 and is located at village : Panga Via: Jharmajri
Hiltop Estate Barotiwala ,Distt : Solan (Himachal Pradesh), India and is engaged in manufacture of
pharmaceutical formulations as per cGMP standards. This sate of art Cephalosporin/General block
manufacturing facility is equipped for the formulation of tablets, Capsules, Dry Syrups and liquids with the
latest Manufacturing machines and has a team of qualified and experienced staff to run the plant.
C.1.2 Pharmaceutical Manufacturing Activities
All the Pharmaceutical Manufacturing Activities will be carried out as per Schedule M of the Indian
Drugs & Cosmetics Act. 1940 & rules there under. The day to day licensing and regulatory activities
are controlled by Drugs & Licensing Authority, Drug controller Himachal Pradesh Food & Drug
Administration.
C.1.3 Other manufacturing activities :
No other manufacturing activity is carried out at the site.
Lic. No. Category of Lic. Form No. Issue Date Valid upto
MNB/07/670 Lic to manufacturing drugs, other than those 25 12.02.2008 11.02.2013
specified in schedule C & C1 of D & C Rules
1945.
MB/07/671 Drugs specified in schedule C & C (1) 28 12.02.2008 11.02.2013
excluding those in schedule X.
C.1.4 Name and Address of the site, including telephone, fax and 24 hour telephone numbers.
C.1.4.1 Name of Company
Celebrity Biopharma Limited
Factory and Village- Panga ,Via- Jharmajri ,Barotiwala ,Dist. Solan (Himachal Pradesh)
Registered Address Web Site : celebritybiopharma.com
e.mail: [email protected]
Corporate Office Executive Business Centre #210/211 SCO :3033,Sector : 22D, Chandirarh-160022
e.mail : [email protected]
C.1.5.2 The specified dosage forms are manufactured in a dedicated manufacturing facility where air emission controls are
designed to prevent the contamination of surroundings.
I. GENERAL BLOCK-
Department Employee
QA / QC. Department 15
Production-(General Block) 55
Production-(Cepha Block) 45
Store and Distribution 11
Security 6
House keeping 15
These Quality principles are used in the planning, designing, construction, testing of quality
systems & qualification of facilities. The Engineering/Maintenance, Materials management,
Vendor development, Production, Quality assurance, Quality control departments are all
required to comply with these quality principles.
C.1.8.3 Elements of the Q.A. System (Organizational structure of Quality Assurance Department
in ANNEXURE-III)
Responsibilities of the Head-Quality Assurance
To ensure the compliance with cGMP.
2.0 To develop procedures & schedules for monitoring and in-process testing of production
process & packaging processes
3.0 To develop procedures for line clearances in production / packaging operations prior to
product change over.
4.0 To conduct process control defect analysis with production and take corrective actions to
prevent reoccurrence in future.
5.0 To conduct periodic cGMP audit (self audit) and initiate corrective actions.
6.0 To investigate market complaints and take necessary precautions.
7.0 Responsible to approve changes/ deviations as per change control system.
8.0 Responsible to approve deviations
9.0 Authorized to initiation of recall of faulty product from the market
10.0 To approve the SOPs, formats, systems, etc.
11.0 To release the batch after reviewing the documents.
12.0 To ensure that all the RM/ Finished product specifications are up dated as per
pharmacopoeia/ addendum etc.
13.0 To organize validation of existing and new products, process, equipment & facilities.
14.0 To ensure adequate training to employees at all levels within the organization to achieve
quality standards.
15.0 To comply with the requirements of all International/ National regulatory requirements or
any other statutory rules.
16.0 To ensure periodical internal audits as per predefined schedule.
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b) A checklist reflecting the key activities is drawn up for each area such as Ware-House,
Engineering/ Utilities, Production, QA, and QC etc.
c) While carrying out audit checks, special attention is to be paid to previous audit finding
and their compliance.
d) Audit finding reports are made for which the concern department makes the compliance
report. And the copy of it is sent to the Chief General Manager-Operation for his review
& comments.
C.1.9.5 The product is analyzed at various stages during manufacturing, as per Quality specifications.
The Quality Assurance department checks the batch manufacturing records and the reports of
analysis along with all data relevant to the quality, efficiency and safety of the product.
C.1.9.6 All the vendors for active raw materials and excipients have manufacturing licenses as per the
local Food and Drug Administration (FDA) and QA Head and Material department for GMP
compliance audits them.
Records of vendor audit /approval and subsequent vendor evaluation are maintained. The
purchase department and the Head-Quality functions are responsible for vendor
development/ evaluation, which are based on their performances.
After complete review of the relevant batch record and confirming the availability of all
necessary certificates of analysis, the Head of Quality Assurance department authorizes the
release of the finished goods & approves the transfer ticket and the goods to be dispatched
for distribution.
C.2 PERSONNEL
Company believes that Quality is derived from people and People are the asset and
strength of Company .Human resource planning is done in the way to assure that right
kind of people will be available in right number and doing right things, which will
result in Production of Quality Products.
C.2.1 Organization chart showing the arrangements for Quality assurance, including
Production, Warehouse, Quality Control & Engineering: Annexure-IV
C.2.2. The Responsibilities of key personnel engaged in Production, Quality Control, Engineering
and utilities are detailed as under -
d) Ensuring achieving the standard yield batch after batch as well as Quality.
d) Ensuring achieving the standard yield batch after batch as well as Quality.
g) Contribute to improvement in systems and practices to ensure adequate care for various
machines with respect to safety, cost saving & energy conservation.
h) To monitor inventory for a required stock level of spare parts of equipment to minimize
the total breakdown time.
j) Maintain & operate various utilities and systems in accordance with GMP practices
k) To ensure compliance to cGMP guidelines and SOPs within the Eng. Dept.
C.2.3 Outline of arrangements for basic and in-service training and how records are
maintained.
All the personnel working in the plant and whose job is directly or indirectly associated with
product quality are given continuous cGMP training, appropriate to their respective job
activities. The Head- Quality Assurance in consultation with the Head-Operation as well as
Head-HRD develop comprehensive training modules and programs for employees at all
levels. Training Activities :
i) For Training of New Employees :The personnel and administration department provide
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induction training to all the new employees for making them acquainted with the companys
policies, practices and people, as per induction training schedule. Records of such induction
training and the reports are maintained by the head of the department (personnel and
administration)
ii) For Training of Existing Employees :
Existing Employees are also trained to update their knowledge related to their job profile and
based on training needs assessed during performance evaluations .The intensive instructions
and Training programme are arranged by Company to give-
a) General Training Management aspects such as motivation ,Time Management ,
Leadership qualities and trends in Pharma Industry.
b) Technical Training Includes Machine Operating Knowledge ,Calibration Process
Validation of Instruments , cGMP, In process Control, FDA and other rules and regulations.
c) Safety Training It includes Safety Practices ,Fire Control, etc.
C.2.3.1 Training on GMP is targeted on the different identified groups. The type of
training given is as follows:
Training needs are then consolidated by the Head of Department (Personnel and
administration) and submitted to Head Quality Assurance. Then Head Quality Assurance
reviews the identified training needs of the individual and prepares an annual training
calendar and gets it approved by Head-Plant Operation, Head-HRD and Authorized by Head-
Technical Operation.
The Head- Quality Assurance organizes training program in accordance with the training
schedule and maintain appropriate training records indicating personnel performance and
need of improvements after evaluation.
C.2.3.3 The training faculty is drawn from the respective area of work from the line of managers and
the senior members from Quality Assurance / Production along with out side experts (if
required) The training program also includes practical training on working site. Following
training aids are used for effective training.
C.2.3.4 Evaluation of Training : The training evaluation is done from the identified training
program as per the training calendar. Giving questionnaires to the group of employees
attending the program does training evaluation. The score in evaluation is taken as criteria for
Re-training. Employees are allowed 3 times more for retaining, failing which they are
transferred to non-critical operations.
C.2.3.5 Records of Training : All the records pertaining to the training in prescribed formats are
available with quality Assurance Department. Records are kept which include the details of
Training, Date of Training conducted, Trainers and Participants name. Every department
maintains the individual training record of the employees of their own department, which is
accessible to the level of supervisors. In case employees are sent to outside training ,the
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report of training is taken from him and kept as record. The responses of evaluation
questionnaires are also kept as record.
All personnel engaged in manufacturing should be free of any contagious disease or severe
type of reaction with specific drugs, like penicillin, sulpha drugs etc.
C.2.4.1 All the new employees have to undergo pre employment medical check ups before joining
the organization. Companys authorized doctor, who is a registered medical practitioner,
carries out pre-employment check-ups.
There is a annual well-organized medical program for all level of staff members and workers
to ensure the health of personnel. Independent professional doctor carries out medical
examination. Any unusual findings during repeat check up, treatment is given to recover
form reported illness. Rechecking is carried out after prescribed time period and personnel
may be granted full rest depending upon the illness. During treatment period, suitable
relocation changes are done in employees job as advised by medical consultant.
C.2.4.3 All the employees engaged in manufacturing activity has to report to their immediate superior
in case of any sickness or if they are in contact with any sick person. Also the employees are
advised to report any type of illness observed by them.
C.2.4.4 A fitness certificate from registered medical practitioner is to be provided by the employee
after recovery from the illness before reporting to his duties.
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C.2.5.1 Suitable changing rooms and washing facilities are provided for each sex before entering the
manufacturing area. Lockers are provided in change rooms for keeping clothes and foot wear
Ist change room and IInd change room are provided with cross over Benches .
C.2.5.2 Appropriate lint free clothing is provided to the employees depending upon nature of their
work. Bouffant type caps are used for proper covering of hair.
Workers are provided with different colors boiler suits, caps, and masks for covering mouth,
nose and footwear. Hand gloves are provided for workers coming direct contact with
products. Staff members are provided with different colors boiler suits and caps. In the core
manufacturing area a procedure of secondary gowning is followed.
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C.2.5.3 Gowning and de gowning instructions in the form of SOPs are kept in each of the change
rooms. The in house laundry facility is available for washing of used company garments.
C.3.1 Premises
Premises have been designed, keeping cGMP, safety and manufacturing capacity in
consideration. Premises and equipment are located, designed, constructed, adapted and
maintained to suit the operators to be carried out. Their layout and design is in such a way
that it is aimed to minimize the risk of errors and permit effective cleaning and maintenance
in order to avoid cross-contamination, any adverse effect on the quality of products.
C.3.1.1 A plan of each production facility with indication of scale and names of the area is attached
as Annexure-V
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Door & windows : All doors apart from CRP are made of anodized aluminum flushed
door having flush glazed view panels.
C.3.3.1 All the areas are provided with appropriate ventilation system to maintain the required room
condition with respect to the temperature, relative humidity, particulate matter count and
potential risk of airborne contamination.
For oral dosage forms the class of air in core processing area meets the requirement of
Grade-D. Pressure differentials are maintained as per the specified guidelines for the
respective dosage forms. Temperature in all areas is 24 2C
Relative humidity in the different sections is as mentioned below.
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The ventilation system design is based on recirculation of air 80-85% of the air is
re-circulated and 15-20% fresh air is taken in.
C.3.3.2 Filtration system for different grade of area
Grade of area Fresh air Return air Pre filter Final filter
filter filter
GRADE-D 10 (EU-4) 20 10(EU-4) 5 (EU-7)
UNDEFINED 10 (EU-4) 10 (EU-4) Not applicable 5 (EU-7)
In addition to above filters, provision of 0.3 (EU-8) filter is made in the system in the Air
Handling Units.
C.3.3.3 Filter replacement pol
All ventilation filters are changed or cleaned for maintenance, as soon as the pressure drop
across filters deviates from the design range. Such replacement & cleaning of filter is
required according to the SOP.
C.3.3.4 Micro Lab HEPA filters are checked for integrity using Dioctyl - phthalate (DOP). Such filters
are scanned for checking the leakage at filter-face of the terminally mounted HEPA filters
using a calibrated Anemometer.
Initial qualification and validation activity is also carried out before use.
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C.3.3.5 Revalidation
Revalidation of the system is carried out as per given frequency or earlier if any changes are
incorporated in the system or in the facility.
Particulate matter count : Once in a year.
Filter integrity testing : Once in a year.
Air changes calculation : Once in a year.
C.3.4 Special areas for the handling of highly toxic hazardous and sensitizing materials:
Separate blocks have been provided for manufacturing of Cephalosporin s products.
b) Cephalosporin Block -
Storage: Water from Bore well is pumped to the various overhead storage tanks. A over
head Tank of 5,000 ltrs has been provided through which water is supplied to Canteen,
Toilets .and various departments for washing purpose . Two overhead Storage tanks of 5,000
ltrs each are provided in which chlorine dosing of 5 ppm is done .Water from these tanks is
pumped to Reverse Osmosis Plant.
steel (SS) From the storage tank ,water is passed through a series of filters of 5 and 2
followed by ultra violet (UV) light and then circulated to various user points.
The annual plan for preventive maintenance of all AHUs and water systems is prepared at the
beginning of the calendar year. This annual plan is prepared with the proposed date of
preventive maintenance as per defined frequency in standard operating procedures.
Preventive maintenance of all AHUs and water treatment plant is carried out as per the
respective preventive maintenance procedures. Record of the preventive maintenance is
maintained in the respective checklist prepared as per the corresponding procedures for
preventive maintenance.
The concerned persons responsible for maintenance are trained about the procedures for
maintenance and the relevant formats for recording.
according to detailed and written procedures and stored only in a clean and dry condition. All
the product contact parts are made up of S.S. stainless steel. All product contact material is
validated during process validation and stability studies on the product. All equipments are
designed as per GMP for cleaning and maintenance. All two blocks are equipped with latest
models of machines and equipments.
The dry syrup department has equipments like sifter, Multi-mill, Fluid bed drier, blender,
powder filling, sealing, bottle cleaning & sticker labeling.
Tablet / Capsules department has equipments like blender, sifter, milling machine,
compression machine, capsule filling machine, stripping and blistering machine.
Quality Control Department -Separate Quality Control Department is there for General
Cephalosporin .s .
The microbiology department is equipped to carry out microbial limit test, bacterial
endotoxin test. Nephelometer and panel viewer for bacterial identification, dry heat sterilizer
for glass ware sterilization, autoclave, BOD incubators, LAFs, heating blocks, membrane
filtration, etc.
List of Equipments Annexure VIII
All the utility equipment and process related equipment are taken into consideration as per
the standard operating procedure of planned preventive maintenance. The engineering
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department is responsible for carrying out maintenance and servicing of the equipment. The
concerned department verifies the maintenance and servicing of the equipment. The annual
plan for preventive maintenance of all equipments is prepared at the beginning of the
calendar year. Such annual plan gives the proposed date of preventive maintenance as per
defined frequency in standard operating procedures.
Preventive maintenance of all equipments is carried out as per the respective preventive
maintenance procedures. Record of such preventive maintenance is maintained in the
respective checklist prepared as per the corresponding procedures for preventive
maintenance.
The engineering department preserves record of maintenance and servicing. Pre and post
approval of the work done for major modifications and changes requires the approval of the
Quality Assurance (QA) department. Various quality checks are identified for certain
maintenance activities. The concern persons responsible for maintenance are trained about
the procedures for maintenance and the relevant formats for recording. There is a separate
SOP for handling equipment breakdown maintenance. If any deviation is found the
engineering department informs to the concerned department and QA on an intimation note
and categories the defect as critical, non-critical, most critical breakdown. The QA
department approves all the corrective actions, if founds recommendation of appropriate
immediate action taken .
considering the requirement of various dosage forms, product, manufacturing conditions and
annual requirement.
All the measuring devices are calibrated against the calibration protocol and certified. All the
parameters are checked against the specification and protocol & certified for performance
qualification.
Prospective Validation
For new products, process validation should be done using the first 3 production batches to
consecutive actual demonstrate the process capabilities of the manufacturing processes.
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Retrospective Validation
Retrospective validation will be conducted based on historical data (trend analysis) etc. This
will generally be performed by demonstrating inter batch consistency (minimum of 20
Batches) at commercial batch scale.
Revalidation
Facilities, systems, equipment and processes, including cleaning, should be periodically
evaluated to confirm that they remain valid. Where no significant changes have been made to
the validated status, a review with evidence that facilities, systems, equipment and processes
meet the prescribed requirements fulfils the need for revalidation.
QA department releases all validation batches after completion of the validation report,
provided that they meet all specifications & have been manufactured in accordance with
GMP. For an out line of process validation please refer C.5.4
A plan for instrument calibration describes the identified instruments with their technical
specifications and frequency for calibration. All the instruments are calibrated as per the
respective standard operating procedures.
Calibration status and observations are attached with the individual instruments, showing the
date of calibration and its next due date for calibration.
Calibration certificates of the instruments and the certificates of calibration of the reference
standards used during the calibration are preserved for the reference.
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If any deviation is found, the engineering department informs to concern department and QA
on intimation note and categories the defect as critical, non-critical, most critical breakdown.
The QA department approves the corrective actions if found appropriate with necessary
recommendations.
C.3.10 SANITATION
Each area in production under goes cleaning as per the standard operating procedures on
cleaning. The SOPs clearly specify the type of detergents to be used and the sanitizing agents
with their concentration and frequency.
All the equipments are cleaned after use as per their cleaning procedure. The cleaning
procedures are validated as per their protocol. The cleaning of equipment is evaluated based
on the rinse water/ swab analysis collected.
The water lines are cleaned as per the standard operating procedure. Sanitization is carried
out using pure steam. The condensate is collected after completion of sanitization and
evaluated for chemical and microbiological parameters.
The air handling system is cleaned as per the standard operating procedures. Pre-filter and
Micro Vee filters are cleaned with wet and dry cleaning method. 5micron filters are
evaluated periodically and if found damaged they are replaced. The ducts are cleaned with
vacuum cleaner, as per the frequency in the standard operating procedures. Dust extraction
systems are vacuum cleaned as per the standard operating procedures.
Wet scrubbers are decontaminated using 2.0% sodium hydroxide solution, which goes to the
primary treatment tank and then to ETP.
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C.4 DOCUMENTATION
The entire documentation system of manufacturing & quality control are very comprehensive
& well controlled to avoid any ambiguity and uncertainty in the plant.
Standard operating procedure (SOP) on preparation, review, approval, authorization &
control of SOP is available. Separate SOP on documentation & data control is also available
which describes the entire documentation system.
Company Quality Policy & Quality System Manuals are available which guides the Quality
Management system to provide products & services of highest standards with total customer
satisfaction. Company quality System Manual covers the following areas:
Premises
Personnel Hygiene
Cleaning & Sanitation
Training
Introduction parameters for Quality System
Good Laboratory Practices & Laboratory Safety
Calibration
Mix-up and Contamination Control
Validation Policy
Water for Pharmaceutical use
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Warehousing
Laboratory Controls
Packaging and Labeling
Release of Semi-Finished and finished goods
Stability Studies
Vendor Approval
Out of specification
Change Control, Deviations
Annual Product Review & Annual quality Review
Product Recall & Market Complaints
Documentation
Self inspection
Master validation plan is available which covers all the aspects of Qualification of facilities,
equipments, process, calibration, and revalidation etc. and documented properly for future
reference.
Each department has its own relevant SOPs, different formats, etc. Each department
develops their respective SOPs, checked by seniors,
C.5 PRODUCTION
C.5.1 Brief description of production operation wherever possible, use flow sheets and charts,
specifying important parameters)
The head of production is professionally qualified and has experience of techniques and
operations of production. He takes every measure to prevent and avoid errors by means of
continuous doers and vigilante checker of the process. As the batch manufacture progresses
the related batch manufacturing records are filled on line on time and completed at every
stage as and when the process is completed. The manufacture of batch is carried out in strict
accordance with master card. Only after the clearance of the packaging line, the new batch is
taken for packaging. Reconciliation is done at critical steps of manufacturing and completion
of packaging operations. Production flow sheets indicate the departmental functioning as per
Annexure-IX
C.5.2 Arrangement for handling starting materials, packaging materials, bulk and finished
products, including sampling quarantine release & storage
Each consignment of material received is examined visually. Damaged goods are labeled as
hold and kept aside for quality Assurances instructions either for disposal or return to party.
On verification of quantity received and batch wise segregation, the details of receipts are
entered in a register called inward register and the Goods Receipt Note (GRN) is generated
with unique serial number.
All the containers are placed in designated area labeled as QUARANTINE, with details of
GRN No. of containers, manufacturer name, material code No. etc.
Samples are drawn as per sampling plan and sampled containers are identified with sampled
sticker and tested as per the respective material specifications by Quality Control
Department. For active Raw Materials ,100% containers are sampled for identification and
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pooled samples are taken for complete analysis. For excipients ,sampling is done as per n+1
but labeling is done on 100% containers .After sampling UNDER TEST labels are affixed on
each container having all the details like material code, quality, total number of containers,
Manufacturers name, Mfd , Exp ,GRN no. etc.
Analyst complies the data after analysis & decides whether the material meets the
specifications or not. Accordingly, he approves /Rejects the material. APPROVED
/REJECTED labels are affixed on the material containers & the same is transferred to
designated storage area APPROVED/REJECTED material accordingly.
All packaging materials are handled as per above procedure and approved/ rejected status
labels are affixed accordingly. Printed packaging materials are stored securely under lock and
key and reissued in requisite number only.
Dispensing of material is done as per SOP on FIFO and FEFO principle. At various places of
operations separate areas are created so that the material or product is held as
QUARANTINE, UNDER TEST, APPROVED and REJECTED etc. Appropriate
material handling devices are used such as trolleys, cages and other suitable containers.
The quality assurance instructions are followed for material status. The production processes,
products and equipments are calibrated and validated at appropriate intervals as per
respective standard operating procedures.
During manufacturing of intermediate products process controls has been carried out. Checks
for blending time, drying time, sieves used, coating time, filter integrity tests are carried out.
Various in process checks depending upon the dosage forms have been carried out, reported
and verified that, whether it is in-line with the marketing authorization.
All packaging materials are coded in such a manner that the code reveals the identity of the
material and also indicate that the material is the one, which is currently in use. Procedures
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are written describing in sufficient detail and the control procedures employed for the
issuance of labeling and issuance recorded. Clearance for intermediate products for next
stage of processing is done only after release of the material from QC. Line clearance and in-
process checks are carried out as per written standard operating procedures.
Equipment, processes & procedures undergo periodic critical revalidation to ensure that they
are capable of achieving intended results. A detailed SOP No. is prepared describing the
detailed process validation procedure.
Quality Assurance releases for packing and for sale semi-finished and finished products
respectively after ascertaining quality. Quality control chemist draws samples of each batch
of each product at specified intervals during entire batch production as per the sampling
program. Complete analysis is done as per the release specifications (Pharmacopoeia or In-
house). Results are recorded in test protocols and reports. The Head of Quality Assurance
after checking the in-process reports releases the product for packaging if it is satisfactory.
The semi-finished product is handed over by production to packing department only after
confirming clearance of Quality Assurance. After reconciliation, packing statement sheet
mentioning batch details and the quality to be packed is filled and sent to QA for approval.
The Head of Quality Assurance verifies that the batch records are satisfactory & gives
Release for sale. The goods are now transferred to finished goods store. Finished products
failing to meet the established standards or specifications are quarantined and kept under
HOLD for investigation, reprocessing or as the case may be. Reprocessing of quarantined
products is performed only in accordance with approved procedure.
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Dispatches of products are ensured on first in & first out basis. The records maintained at
Celebrity Biopharma ltd permits full batch traceability from the factory to the customer, in
terms of date of dispatch, customer details and quantity dispatched.
The distribution records of domestic products are maintained in such a way that
irretrievability of the product marketed can be ensured fast, in case of withdrawal or recall.
Details of complaint, investigation report, Action plan and reply to the complainant constitute
documents of complaint handling procedure. The records remain with the Head-QA
Complaint records are stored minimum for three months after the expiry of the product in
question.
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Product Recall
We have got written procedure for product recalls. General Manager-Operations is
responsible for product recall, whether it is on the instructions from drug authorities (FDA)
or it is a voluntary withdrawal. Details in approved format are filled.
FDA is informed about stock manufactured, distribution details and quality recalled.
The quantity received if any, after recalling a batch is kept in secured dedicated area till the
decision about its disposal is taken.
If recall of a product is at the instance of local drug authorities, the final disposal is done in
their presence, but if it is a voluntary withdrawal, the decision of Head Technical operations
is final.
7) Validation and frequent cleaning of Dust control equipments to confirm its capacity to
There is a self inspection schedule according to which periodic self inspection of all the area
is carried out by a team comprising of personnel from various departments. The entire
process is organized by Q.A. Department .the self inspection carried out is submitted to
QA/QC-Manager and Production Manager .the action plan is decided on the points during
audit and compliance reports are submitted .The next audit would ensure that compliance to
earlier points is done.
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ANNEXURE I
LIST OF PRODUCT MANUFACTURED AT SITE
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ANNEXURE II
SITE MAP
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ANNEXURE -III
ORGANISATION CHART OF QUALITY ASSURANCE DEPARTMENT
MANAGING DIRECTOR
EXECUTIVE DIRECTOR
MANAGER-QUALITY
ASSURANCE
EXECUTIVE-QUALITY
ASSURANCE
ANNEXURE-IV
ORGANISATION CHART
CELEBRITY BIOPHARMA LTD.
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ANNEXURE V (a)
LAYOUT OF GENERAL BLOCK
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ANNEXURE V (b)
LAYOUT OF CEPHALOSPORIN BLOCK
(GROUND FLOOR PLAN)
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ANNEXURE V (a)
LAYOUT OF GENERAL BLOCK
(FIRST FLOOR PLAN)
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ANNEXURE V (b)
ANNEXURE-VII C
LAYOUT OF Q.C. BLOCK
(FIRST FLOOR PLAN)
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ANNEXURE VI (a)
VENTILATION SYSTEM OF GENERAL BLOCK
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ANNEXURE VI (b)
VENTILATION SYSTEM OF CEPHALOSPORIN BLOCK
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ANNEXURE VI (b)
VENTILATION SYSTEM OF CEPHALOSPORIN BLOCK
CELEBRITY BIOPHARMA LTD.
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INFRARED CBL/QCI/004
4 BUCK SCIENTIFIC 500 CBL-QCC-004
SPECTROPHOTOMETER
DISSOLUTION TEST CBL/QCI/005
5 ELECTROLAB TDT-06P CBL-QCC-005
APPARATUS
CBL/QCI/006
6 FRIABILITY APPARATUS ELECTROLAB EF-1W CBL-QCC-006
PLORIMETER CBL/QCI/007
7 NAVYUG UDYOG --------- CBL-QCC-007
APPARATUS
REFRACTOMETER CBL/QCI/008
8 NAVYUG ---------- CBL-QCC-008
APPARATUS
CBL/QCI/009
9 HARDNESS TESTER TAB MACHINE MEPA CBL-QCC-009
CBL/QCI/010
10 VERNIER CALIPERSE MITUTOYO CBL-QCC-010
CBL/QCI/011
11 SIEVE SHAKER ELECTROLAB EMS-8 CBL-QCC-011
CBL/QCI/012
12 TAP DENSITY ELECTROLAB ETD-1020 CBL-QCC-012
CBL/QCI/015
15 LEAK TEST APPARATUS SHIVANI LTA 6M CBL-QCC-015
DISINTEGRATION ED 2 CBL/QCI/018
18 ELECTROLAB CBL-QCC-018
APPARATUS SAPO
CBL/QCI/019
19 HOT AIR OVEN NAVYUG Q-5247 CBL-QCC-019
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INSTRUMENTSOP INSTRUMENT ID
SR. NO. NAME OF INSTRUMENT MAKE MODEL
NO. NO.
CBL/QCI/020
20 MUFFLE FURNACE NAVYUG ----------- CBL-QCC-020
CBL-QCC-021 CBL/QCI/021
21 VACUUM OVEN NAVYUG ---------
WATER STILL
23 CBL-QCC-023 CBL/QCI/023
APPARATUS
MAG.STIRRER WITH
24 NAVYUG ---------- CBL-QCC-024 CBL/QCI/024
HOT PLATE
CENTRIFUGE
26 REMI R-8C CBL-QCC-026 CBL/QCI/026
APPARATUS
MICROCENTRIFUGE
27 REMI R-12C CBL-QCC-027 CBL/QCI/027
APPARATUS
VORTEX SHAKER
28 REMI CM-101 CBL-QCC-028 CBL/QCI/028
MAKER
ULTRASONIC WATER
33 LEOCHEM 6.5 L 200 CBL-QCC-033 CBL/QCI/033
BATH
ULTRASONIC BATH
35 ANALYTICAL 2K706009 CBL-QCC-035 CBL/QCI/035
SONICATOR
IR MOISTURE
37 NAVYUG Q-5247 CBL-QCC-037 CBL/QCI/037
ANALYZER
INSTRUMENT
SR. NO. NAME OF INSTRUMENT MAKE MODEL INSTRUMENT ID NO.
SOP NO.
GDA23C/2
51 REFRIGERATOR GODREJ CBL-QCC-051 CBL/QCI/051
007
VERNIER
52 MITUTOYO --- CBL-QCC-052 CBL/QCI/052
SCALIPERSE(IPQC)
HARDNESS TESTER
53 ------------- T-MHT-20 CBL-QCC-053 CBL/QCI/053
(IPQC)
FRIABILITY APPARATUS
54 ELECTROLAB EF-1W CBL-QCC-054 CBL/QCI/054
(IPQC)
DISINTEGRATION
55 ELECTROLAB Ed-2 CBL-QCC-055 CBL/QCI/055
APPARATUS (IPQC)
ZEAL
57 THERMOMETER --- CBL-QCC-057 CBL/QCI/057
THERMOMETE
ZEAL
58 THERMOMETER --------- CBL-QCC-058 CBL/QCI/058
THERMOMETE
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ANNEXURE-VIII (a)
LIST OF EQUIPMENT FOR PRODUCTION DEPARTMENT
Sr.No. Name of equipment Make
GENERAL BLOCK(TABLETS/LIQUID)
1. MECHANICAL SIFTER 30'' Saan
2. MULTIMILL Saan
3. MECHANICAL SIFTER 30'' Saan
4. STARCH PASTE KETTLE 150L Saan
5. RAPID MIX GRANULATOR 600 Saan
6. FLUID BED DRYER 150KG Saan
7. MULTIMILL Saan
8. DUST COLLECTOR Prism
9. OCTAGONAL BLENDER 600L & 1000 lits Saan
10. MULTIMILL Saan
11. TABLET COMPRESSION MACHINE-27 STATION Prism
12. TABLET COMPRESSION MACHINE 35 STATION Prism
13. TABLLET DEDUSTER MACHINE Prism
14. TABLET COATING MACHINE Global pharma
15. BLISTER PACKING MACHINE3000- I Rapid
16. STRIP PACKING MACHINE Hemson
17. BOTTLE WASHING MACHINE 01 Pharma lab
18. 6 HEAD FILLING MACHINE Pharma lab
19. 6 HEAD CAPPING MACHINE Pharma lab
20. BOTTLE INSPECTION TABLE Pharma lab
21. FILTER PRESS Golbal pharma
22. LABELLING MACHINE Ambica machine
23. CARTON CODING MACHINE willet
24. SHRINK WRAPPING MACHINE (LIQUID)
25. COLLOIDAL MACHINE (COATING) Saan
26. LEAK TEST APPARATUS Shivani
27. FRIABILITY TESTING APPARATUS Electrolab
28. DISINTEGRATION TESTING APPARATUS Electrolab
29. HARDNESS TESTING APPATATUS Tab machine
30. MOISTURE ANALYZER Navyug
31. VERNIER CALIPER(IPQC) Mitutoyo
32. SHRINK WRAPPING MACHINE (TABLET)
33. ELECTRONIC WEIGHING BALANCE (100KG) Sartorious
GRANULATION
34. ELECTRONIC WEIGHING BALANCE (100KG) Sartorious
PACKING CONVEYOR-I
35. ELECTRONIC WEIGHING BALANCE (100KG) Sartorious
PACKING CONVEYOR-II
36. ELECTRONIC WEIGHING BALANCE (100KG) Sartorious
PACKING CONVEYOR-LIQUID
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ANNEXURE-VIII (a)
ANNEXURE IX
PROCESS FLOW CHART
MANUFACTUREING FLOW CHART FOR TABLETS
DISPENSING IPQC
DISPENCING
SIFTING IPQC
BINDER PREPARATION
DRY MIXING
GRANULATION
SIZING
LUBRICATION
DISPENCING IPQC
COMPRESSION
SIFTING IPQC
COATING IPQC
PACKING IPQC
ANNEXURE-IX
PROCESS FLOW CHART
DRY SYRUP MANUFACTURING & PACKAGING
DRYING OF SUCROSE
(FBD)
SIFTING OF EXICIPIENTS
MECHANICAL SIFTER
BLENDING (Octa-blender)
ANNEXURE-IX
PROCESS FLOW CHART
CAPSULE MANUFACTURING & PACKAGING
CAPSULE FILLING
(AUTOMATIC CAPSULE FILLING)
PACKAGING
CELEBRITY BIOPHARMA LTD.
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ANNEXURE-IX
PROCESS FLOW CHART
LIQUID MANUFACTURING AND PACKING
SUGAR
TRANSFER
MATERIAL
WEIGHING &
SIFTING SUGAR SYRUP
PREPARATION
SOLUTION
PREPRATION MIXING
FILLING
LABELLING
PACKING