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RABIES VACCINE UNIT

Validation protocols for the Rabies laboratory


The following is a comprehensive listing of equipment, systems, processes and procedures which should be validated..
A. Waste Systems B. Air Handling Systems (IQ/OQ/PQ) C. Water System (IQ/OQ/PQ)
1. Domestic sanitary sewer systems 1. Heating system 1. Purified water
2. Process drain systems 2. Ventilation system 2. Water for injection (WFI)
3. Hazardous waste systems 3. Air conditioning system 3. Source potable water
4. Solid waste disposal systems 4. Air filter systems
5. Hazardous emissions systems 5. Biological safety cabinets
6. Laminar flow hoods
D. Steam Systems (IQ/OQ/PQ) E. Cooling Systems (IQ/OQ/PQ) F. Gas Systems (IQ/OQ/PQ)
1. Plant steam (raw steam) 1. Chillers CO2
2. Clean steam 2. Cooling towers
G. Electrical System (IQ/OQ) H. Equipment(IQ/OQ) I. Sterilization
1. Electrical standard 1. Production 1. Steam sterilization
2. Electrical emergency power 2. Quality control laboratory (autoclaves)(IQ/OQ/PQ)
3. Electrical back-up power a. Component preparation
sterilizer
b. Terminal sterilizer
c. Laboratory sterilizer
2. Dry heat
sterilization/depyrogenation
(IQ/OQ/PQ)
b. Ovens
3. Terminal filtration process
J. Cleaning Processes K. Component Preparation Equipment
1. CIP (Clean-in-Place) process 1. Container washing equipment L Aseptic Solution Preparation
a. Aseptic (IQ/OQ/PQ) 1. Solution manufacture process
b. Non-aseptic a. Manual 2. Solution filtration process
2. SIP (Sterilize-in-Place) process b. Semi-automatic (programmable
3. Facility cleaning processes controllers)
a. Equipment c. Automatic (computer controlled)
b. Clean area 2. Closure washing equipment (IQ/OQ/PQ)
c. Aseptic area a. Manual
d. Sanitization b. Semi-automatic (programmable
e. Garment laundering controllers)
f. General facility cleaning c. Automatic (computer controlled)
(janitorial) 3. Washing/depyrogenation/sterilization
processes
M. Sterile Filling (Aseptic or N. Finishing O. Manufacturing Processes
Terminally Sterilized) 1. Labeling process 1. Cell separation
1. Solution filling a. Manual 2. Cell growth
a. Manual b. Semi-automatic a. Roller bottle
b. Automatic c. Automatic 3. Buffer preparation
3. Container sealing 2. Packaging (boxing) process a. Buffer weigh-up.
a. Manual vial stoppering b. Buffer preparation
b. Automatic vial stoppering i. Sterile filtration
c. Ampoule sealing ii. Sterilization
4. Container capping c. Buffer storage
4. ultrafiltration
a. inactivation
b. adjuvanisation
P. Storage/Warehouse Operations Q. Analytical Methods R. Other
(Storage, Holding, Distribution) 1. Raw materials 2. Vendor validation/supplier
1. Incoming/Receiving 2. In-process product audit
2. Warehousing 3. Intermediates 3. Animals
3. In process storage 4. Final product a. Animal care and handling
4. Approved finished goods storage processes
5. Outgoing/distribution/shipping b. Supplier validation (audit)

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Validation and Calibration Documents related to Rabies Vaccine


Master Validation Plan for the Vaccine Facility
Design qualification for the clean rooms
Installation Qualification for Classed and UnClassed Rooms
Performance Qualification for Classed and UnClassed Rooms
Design qualification for the HVAC
Installation Qualification for the HVAC Systems
Operational Qualification for the HVAC Systems
Performance Qualification for the HVAC Systems
Design qualification for the cold rooms
Installation Qualification for Classed and UnClassed Cold Rooms
Operational Qualification for All Cold Rooms
Design qualifications for the hot rooms
Installation Qualification for Incubators
Operational Qualification for Incubators
Design qualification for the BS 3 hood
Installation Qualification for the BS 3 hood
Operational Qualification for the BS 3 hood
Performance Qualification for the BS 3 hood
Installation Qualification for Class 100 Hoods
Operational Qualification for Class 100 Hoods
Design qualification for the ultrafilteration system
Design qualification for the double ended autoclaves
Design qualification for the depyrogenators
Calibration of Cage Washer Thermocouples
Installation Qualification of Autoclaves
Operation Qualification of Autoclaves
Calibration of Humidity Recorders
Caliberation of temperature recorders
Caliberation of pressure recorders
Caliberation of anemometers
Operation Qualification of Millipore water System
Performance qualification of Millipore water System
Validation of Millipore water System
Installation Qualification of WFI Distribution System
Operation Qualificationof WFI Distribution System
Installation Qualification for Refrigerators and Freezers
Operational Qualification for Refrigerators and Freezers
Installation Qualification for the ………………….Environmental Monitoring System
Validation of Filling Equipment Cleaning
PQ for Unclassed Cold Rooms Refrigerators, Freezers, and Incubators
PQ for Biological Safety Cabinets and Laminar Flow Hoods
PQ for HVAC
Performance Qualification and Process Validation for ……………….Centrifuge Calibration of
Hydrometers
Calibration of Sanitary Gagues
Calibration of ………………… Viable Air Sampler
Validating & Monitoring of Glassware Prep.
Validation Plan for Computerized Systems at ...................
OQ of Calibration Manager
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Process Validation Bulk Transfer to Filling


Annual Standardization of RABIES VACCINE
Validation Procedure for the UltraFiltration of culture
Validation of Cleaning processes Using Swabs
Quarterly Calibration of Cold Rooms, Incubators, and water Baths
Calibration of Pressure Gauges
Requirements for Validating Assays in QC
QC Testing of Trypicase Soy Broth Medium for Broth Fills Validation
Glassware Cleaning and Validation of Cleaning
Validation of clean room cleaning
Validation of surface sterilization
Validation of hydrogen peroxide fumigation
Standardization of Thermometers
Validation of analytical assays
a. NIH test
b. virus

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Validation protocol No. effective date


Title: MASTER VALIDATION PLAN
Written by: Edited by:
Revised by: Section:
Revision No.: Revision date:

1. INTRODUCTION

2. ORGANIZATIONAL STRUCTURE OF VALIDATION ACTIVITIES

3. PLANT/PROCESS/PRODUCT DESCRIPTION

4. SPECIFIC PROCESS CONSIDERATION

5. LIST OF PRODUCTS/PROCESS/SYSTEMS TO BE VALIDATED

6. KEY ACCEPTANCE CRITERIA

7. DOCUMENTATION FORMAT

8. REQUIRED SOPs

9. PLANNING &SCHEDULING

10. CHANGE CONTROL

Senior Research Officer Quality Control Officer

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Validation protocol No. DESIGN QUALIFICATIONS Effective date:


Title: DESIGN QUALIFICATION OF ……………………………………..
Written by: Edited by:
Revised by: Section:
Revision No.: Revision date:

OBJECTIVE

To ensure that the system/equipment installed conforms to the purchase specifications and the manu-facturers

literature, and to document the information that the equipment meets specifications.

SCOPE

To be performed at time of installation, modification, or relocation.

RESPONSIBILITY

Person overseeing the design will perform the qualification and record the information.

The responsible engineer will verify the records and write the report.

Quality Assurance will review and approve the IQ Protocol and Report.

DESIGN INPUTS

System/Equipment _______________________________ Code No. _______________

a Description of the System/Equipment being installed: General description of the function and

the main components.

____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
b List of the main components
1 _____________________________________________ Code # _______________
2 _____________________________________________ Code # _______________
3 _____________________________________________ Code # _______________
4 _____________________________________________ Code # _______________
5 _____________________________________________ Code # _______________
6 _____________________________________________ Code # _______________
c Description of any required supporting utilities (piping, connections, water supply).
1 _____________________________________________ Code # _______________
2 _____________________________________________ Code # _______________
3 _____________________________________________ Code # _______________
4 _______________________________

DESIGN BASIS

ACCEPTANCE CRITERIA

SYSTEM DESCRIPTION

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REFERENCE DOCUMENTS

MANUFACTURER’S COMMUNICATION

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Validation protocol No. INSTALLATION QUALIFICATION


Title: INSTALLATION QUALIFICATION OF ……………………………..
Written by: Edited by:
Revised by: Section:
Revision No.: Effective date: Revision date:

OBJECTIVE

To ensure that the system/equipment installed conforms to the purchase specifications and the manufacturers

Literature, and to document the information that the equipment meets specifications.

SCOPE

To be performed at time of installation, modification, or relocation.

RESPONSIBILITY

Person overseeing the installation will perform the qualification and record the information.

The responsible engineer will verify the records and write the report.

Quality Assurance will review and approve the IQ Protocol and Report.

System/Equipment _______________________________ Code No. _______________

A DESCRIPTION OF THE SYSTEM/EQUIPMENT BEING INSTALLED:

Name of system Model Serial No. Manufacture’s address Suppliers address

B LIST OF THE MAIN COMPONENTS


1 _____________________________________________ Code # _______________
2 _____________________________________________ Code # _______________
3 _____________________________________________ Code # _______________
4 _____________________________________________ Code # _______________
5 _____________________________________________ Code # _______________
6 _____________________________________________ Code # _______________

C DESCRIPTION OF ANY REQUIRED SUPPORTING UTILITIES (PIPING, CONNECTIONS, WATER SUPPLY).


1 _____________________________________________ Code # _______________
2 _____________________________________________ Code # _______________
3 _____________________________________________ Code # _______________
4 _____________________________________________ Code # _______________

Checklist for Component Number _____ Name ________________________ Code # ______

Component Function: _______________________________________________________

SL NO Required/ordered Actual Deviations


1 MODEL/SERIAL No.
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2 Specifications
3 Manual/booklet
4 Drawing
5 Wiring/cabling
6 Power, fusing
7 Operation SOP,
maintenance SOP
calibration SOP
8 Input/output control
9 Environmental
requirement
10 Test equipment or
instrument
11 Utilities and services
12 Spare part list, part
No. and supplier
13 Others

DEVIATION REPORT

Deviation(s):

Justification for acceptance:

Impact on operation:

PHYSICAL DETAILS
Serial No. Description Particulars
1 Overall dimension
2 Weight
3 Colour code
4 Surface finish
5 Motor/gear box/pulleys etc
6 Electrical rating
7 Details of auxiliary equipments

SOP s

FUNCTION SOP No. Date of issue Revision no & Title Next revision
date

CALIBRATION REVIEW

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Process Location Date of Calibrated by Checked by Next calibration


instrument calibration due on

Test Location Date of Calibrated Checked Next calibration Component to be


instrument calibration by by due on calibrated

SYSTEM / INSTRUMENT CHECK LIST

Sl. No. Statement YES/NO Observed by Date


Space for installation
Power
Compressed air
Steam
Vacuum
Water, plumbing, drainage
Others

DRAWINGS

Sl. Drawing Category Location Drawing No Date Physical

No. verification
Piping and instrumentation
General arrangement/schematic diagram
Utility
Isometric
Others

SUPPORT UTILITIES

Utility Facility Capacity required Capacity available Properly connected

&identified(Y/N)

MANUFACTURER’S SUBMISSIONS

1. commissioning report

2. test report

3. calibration certificates

4. others

Report Written by: ______________________________________________ Date ___________

INSTALLATION QUALIFICATION REPORT

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RESULTS:

CONCLUSIONS

Report Written by: ______________________________________________ Date ___________

QA approved by: ________________________________________________ Date ___________

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Validation protocol No. OPERATIONAL QUALIFICATION


Title: OPERATIONAL QUALIFICATION OF
Written by: Edited by:
Revised by: Section:
Revision No.: Effective date: Revision date:

OBJECTIVE

To determine that the system/equipment operates according to specifications, and to record all relevant

information and data to demonstrate it functions as expected.

SCOPE

To be performed after installation, modification or relocation, after the Installation Qualification has

been completed.

RESPONSIBILITY

Person responsible for operating the system/equipment will perform the qualification and record the

information.

The supervisor will supervise the study, verify the completion of the records, write the deviation report

and the Operational Qualification Report.

Quality Assurance will review and approve the OQ Protocol and Report.

MATERIALS OR SUPPLIES NEEDED TO PERFORM THE OPERATIONAL QUALIFICATION

1 _____________________________________________ Code # _______________


2 _____________________________________________ Code # _______________
3 _____________________________________________ Code # _______________
4 _____________________________________________ Code # _______________
5 _____________________________________________ Code # _______________
6 _____________________________________________ Code # _______________

CALIBRATING APPARATUS AND INSTRUMENTS.

Apparatus/Instrument Calibration method Calibration date

Performed by: ______________________________________________ Date _______________

Deviations:

Verified by: ________________________________________________ Date

________________

DOCUMENT CHECK

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SOP Title Number File Location QA/QC approval


date

TRAINING RECORDS

Course on SOP # Staff name Date

Equipment Make Model Manual Available (Y/N)

Performed by: ______________________________________________ Date _______________

Deviations:

Verified by: ________________________________________________ Date ________________

Results

CONTROL PANEL FUNCTIONALITY

Purpose

Testing

Functionality test results

Equipment Make Serial no. Location of Control panel Location of

No equipment sl.no control

pannel

Component of control panel Described function Description matches function

(Y/N)

Results

Performed by: ______________________________________________ Date _______________

Deviations

Verified by: ________________________________________________ Date ________________

SAFETY FEATURES REVIEW

Safety features Description Applicable/not applicable(Y/N)

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extreme temperature Hot line/equipment insulated


Personal protection available
Heat source identified and shielded
Sign post to alert operations
Pressure considerations All piping properly aligned
Pressure ratings of piping
components is compatible with
operating conditions
Pressure release devices provided
where applicable
Compressed air / gas lines can be
isolated and blended to zero energy
state
ASME stamps
Vessel registered with site services
for insurance registration
Calculations for pressure release
devices
Hazardous materials of fluid
Material safety data sheet (MSDS)
nature location
If required, SOP for handling
available

Spill retention provided


Toxic and flammable chemical risks
controlled

Biohazards information provided

Electrical hazards
All wiring properly placed
All systems properly grounded
Lock-outs available on all
equipment emitting ionizing
radiations
Proper shielding provided
Moving parts

Guards provided are in place at


pinch points
Lock nut on shaft
Belt tension properly adjusted
Noise leval Noise level is dB on scale Ambient
noise level is

Noise reduction equipment /devices


in place, if required

Physical environmental factors Sharp edges removed or protected

Trip/fall hazards eliminated or


protected against
Low clearance head space clearly
indicated or eliminated
Equipment properly anchored

Eye hazards eliminated

Adequate lighting provided in the


area
Warning and precautionary signs
provided wherever required

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Ergonomic design Ergonomic risks evaluated, operators


can safely and conveniently access
all
areas of equipment
Adequate operator visibility
Emergency stop buttons visible,
accessible, labeled, and operational
Warning bells and lights audible,
visible and functional
Belt/conveyor/table width appropriate
for manual operations
Hazardous equipment not
operational without safety guard
Excessive reaching, body bending,
weight lifting, pushing and pulling
eliminated or minimized
Personnel protective equipment to
be worn when operating is indicated
Dust level Particulate matter concentration
Respiratory equipment / device in
place if required.

CONTROL POINTS AND ALARMS.

Control point/Alarm Results Date

Performed by: ______________________________________________ Date _______________

Deviations

Verified by: ________________________________________________ Date ________________

Results

OUTPUTS

Outputs Results Date

Performed by: ______________________________________________ Date _______________

Deviations:

____________________________________________________________________________________________
Verified by: ________________________________________________ Date ________________

CALIBRATION OF EQUIPMENT/SYSTEM

Calibration SOP Result Date

Performed by: ______________________________________________ Date _______________


Deviations:

Verified by: ________________________________________________ Date ________________


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SPECIFIC CHALLENGE OF THE EQUIPMENT OR SYSTEM

Test in normal conditions:

Test of worst case situation:

(e.g. start-up after shutdown, temperature recovery time, centrifuge imbalance)

Performed by: ______________________________________________ Date _______________

Deviations:

Verified by: ________________________________________________ Date ________________

DEVIATION REPORT

Deviation(s):

Justification for acceptance:

Impact on operation:

Written by: ______________________________________________________ Date ___________

OPERATIONAL QUALIFICATION REPORT

Results:

CONCLUSIONS:

Written by: __________________________________________________ Date ___________


QA approved by: _____________________________________________ Date ___________

DEFINITIONS AND ABBREVIATIONS

REFERENCE DOCUMENTS

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Validation protocol No. 1 PERFORMANCE QUALIFICATION


Title: PERFORMANCE QUALIFICATION OF ………………………
Written by: Edited by:
Revised by: Section:
Revision No.: Effective date: Revision date:

OBJECTIVE

To determine that the systems/equipment perform as intended by repeatedly running the system on

its intended schedules and recording all relevant information and data. Results must demonstrate

that performance consistently meets pre-determined specifications under normal conditions, and

where appropriate for worst case situations.

SCOPE

To be performed after the Installation and Operational Qualification have been completed and approved.

To be performed after installation, modification or relocation and for re-validation at appropriate intervals.

Each piece of equipment must be validated before it serves another piece of equipment/system during

validation of the latter (e.g. water system before steam generator; steam generator before autoclave).

RESPONSIBILITY

Person responsible for operating the system or equipment will perform the qualification and record

the information.

The supervisor will supervise the study, verify the completion of the records and write the Deviation

Report and the Performance Qualification Report.

Quality Assurance will review and approve the Performance Qualification Protocol and Report.

MATERIALS, EQUIPMENT, DOCUMENTS

SOPs for normal operations of the equipment or system under test (including data record forms,

charts, diagrams materials and equipment needed). Attach copies.

SOP LIST:

SOPs specific for performance tests (including data record forms, charts, diagrams, materials and

equipment needed, calculations and statistical analyses to be performed, and pre-determined specifications

and acceptance criteria). Attach copies.

SOP LIST:

PROCEDURE

Equipment: Run normal procedure three times for each use (configuration or load) and record all

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required data and any deviations to the procedure.

Systems: Run for 20 consecutive working days, recording all required data and any deviations to the

procedure.

Attach all completed, signed data record forms.

SUMMARY DATA RECORD (TO BE PREPARED FOR THE SPECIFIC PROCEDURE ON TEST)

Performed by: _____________________________________________ Date ___________

Verified by: ________________________________________________ Date ___________

CALCULATIONS AND STATISTICAL ANALYSES

Performed by: _____________________________________________ Date ___________

Verified by: ________________________________________________ Date ___________

ACCEPTANCE CRITERIA VS. PERFORMANCE TEST RESULTS

Criteria Results Pass/Fail

Performed by: _____________________________________________ Date ___________

Verified by: ________________________________________________ Date ___________

DEVIATION REPORT

Deviation(s):

JUSTIFICATION FOR ACCEPTANCE:

Impact on operation, function or process:

Written by: _________________________________________________ Date ___________

Verified by: _________________________________________________ Date ___________

PERFORMANCE QUALIFICATION REPORT

Results:

Conclusions:

Written by: _________________________________________________Date ___________

Verified by: ________________________________________________ Date ___________

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Validation protocol No. 1 PROCESS VALIDATION

Title:
Written by: Edited by:
Revised by: Section:
Revision No.: Effective date: Revision date:
OBJECTIVE:

To determine that process consistently performs as intended by repeatedly running the system

on its intended schedules and recording all relevant information and data. Results must demonstrate

that the process meets pre-determined specifications under normal conditions, and where

appropriate worst case conditions.

SCOPE

To be performed with validated equipment in the specified location in validated premises. If

equipment or systems or the facility are modified or the premises where the process takes place

is changed, or the process is relocated, the process must be re-validated after the systems,

equipment and facility qualifications, as appropriate, have been performed and approved.

RESPONSIBILITY

The persons responsible for the process will perform the validation and record the information.

The responsible person will supervise the study, verify the completion of the records and write the

report.

Quality Assurance will review and approve the Process Validation Protocol and Report.

MATERIALS, EQUIPMENT, DOCUMENTS

Master Formula or SOPs for normal operations of the process under test. (including data record

forms, batch record forms, materials and equipment needed).

MF/SOP LIST:

SOPs for in-process and quality control tests performed during process (validated tests) (including

data record forms, materials and equipment needed).

SOP LIST:

SOPs for test specific to the validation study performed (validated tests) (including data record

forms, materials and equipment needed).

SOP LIST:

PERFORMANCE

Process: Run full process according to SOP three times and record all required data.

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Deviations to the procedures must be recorded on the data record forms.

Analytical tests: Perform the routine tests associated with the process according to

the SOP. Test results must be approved by QC.

EVALUATION

ATTACH ALL DATA RECORD FORMS AND CHARTS.

LIST OF ATTACHED DATA RECORD FORMS

Verified by: ______________________________________________Date ___________

CALCULATIONS AND STATISTICAL ANALYSES

Performed by: _________________________________________ Date ______________

Verified by: ___________________________________________ Date ______________

ACCEPTANCE CRITERIA VS. TEST RESULTS

Criteria Results Pass/Fail

Recorded by: ___________________________________________ Date _____________

Verified by: ____________________________________________ Date _____________

DEVIATION REPORT

Deviation(s):

JUSTIFICATION FOR ACCEPTANCE:

Impact on process:

Supervisor: _____________________________________________________ Date

_________

PROCESS VALIDATION REPORT

Results:

Conclusions:

Written by: _____________________________________________ Date _____________

QA approved by: ________________________________________ Date ____________

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Validation protocol No. ANLYTICAL ASSAY VALIDATION

Title: Effective date:

Written by: Edited by:

Revised by: Section:

Revision No.: Revision date:

OBJECTIVE

To demonstrate in a laboratory study that the performance characteristics of an assay make it fit

for the intended analytical application.

To record the information and data needed to establish the performance specifications for the

assay.

SCOPE

To be performed for new assays, or for current assays when any changes are made to the

equipment, procedure, laboratory conditions, technical staff, reagents and starting materials,

references/standards/ controls, etc.

All equipment must be validated before being used for the validation of an analytical assay.

RESPONSIBILITY

Person trained and responsible for performing the analytical test will perform the validation study

and record the information.

The supervisor will plan the study, write the protocol, supervise the performance, and verify the

completion of the records.

QA will review and approve the protocol before the validation study, and review and approve the

data in validation report.

MATERIALS, EQUIPMENT, DOCUMENTS

SOP AND DATA RECORD FORMS FOR THE ASSAY UNDER TEST.

MATERIALS AND EQUIPMENT AS DESCRIBED IN THE SOP.

REFERENCE TO DOCUMENTS

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PROCEDURE

PERFORMANCE

CONDITIONS FOR THE PERFORMANCE OF THE TEST,

EVALUATION

ATTACH ALL DATA RECORD FORMS AND CHARTS.

CALCULATIONS AND STATISTICAL ANALYSES

Performed by: __________________________________________ Date _____________

Verified by: ____________________________________________ Date ______________

ACCEPTANCE CRITERIA VS. TEST RESULTS

Criteria Results Pass/Fail

Recorded by: __________________________________________ Date ___________

Verified by: ____________________________________________ Date ______________

DEVIATION REPORT

Deviation(s):

JUSTIFICATION FOR ACCEPTANCE:

IMPACT ON PROCESS:

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Written by: ________________________________________________ Date _________

ASSAY VALIDATION REPORT

Results:

CONCLUSIONS:

Written by: _____________________________________________ Date _____________

QA approved by: _________________________________________

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Format for a standard operating procedure (SOP)

SOP Number ________


Title_________________________________________________
Revision number ________
Written by _________________________Edited by__________________________
Authorization signature ________________________ Department _______
Date___________
Effective date ____________________________________ Replaces ___________________

Purpose:

Scope

Responsibility

Materials and equipment

Procedure

Reporting

Reference documents:

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DATA RECORD FORM

Name of facility.........................................page....... of .......

Data Record Form #....... rev #.......


SOP reference number....................
Title _________________________________

Preparation
Materials checklist (buffers, glassware, supplies, QC approved dates if required)
Equipment checklist (including specific numbers if there is a choice)
Buffer, media, cleaning solution, etc preparation if necessary. Reference to SOP

Step by step Instructions


Presented in the order in which the work is routinely performed.
Brief instructions with blanks for all data to be filled in.
Dates and times for all operations, especially if procedure takes several days, or if there are
Specification limits to be met.
Blank for verification signature for critical steps where necessary.
Blanks for calculations as required and in order performed.
Instructions for sending intermediate samples for testing, if appropriate.
Instructions for storage during any waiting periods.
Criteria for repeating test or procedure.
Instructions for reporting any deviations, or problems.
Instructions for correcting mistakes (no erasures, cross-out, add correct information and
Initials)

Signatures
Operator (technician) _____________________________ Date ____________
Verification (supervisor)___________________________ Date ____________

Instructions for filing and approval


State where completed data sheet is to be delivered, copied, and filed.
Submit to QC or QA for review and approval of the data.

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MASTER FORMULA RECORD

Master Formula: Revision number 2


Product Name _______________ Product Code _______________ Batch
Size _____
Written by _________________ Edited by
_____________________________
Production Approval Signature _________________ Date ____________
Authorization Signature _________________ Department (QA/QC)
________ Date ___________
Effective date_________________ Replaces Rev 1 .

Part 1: CELL CULTURE


Batch size _________________ Roller bottle Lot No. _______
Theoretical Yield ____________
Date Started: ______________ Operators ________________
________________
Date Finished: ______________ ________________
________________
Day 1: Preparation:
This section should list all the preparative work and checks which are
required before beginning
the procedure. A checklist for: facility preparation; production location;
equipment preparation;
reagent preparation; and for preparation and entry of incoming supplies
needed for the days operations
is found in this section of the record. The checklist should give reference to
the SOP
numbers followed during the preparation, expiry dates of reagents where
applicable, QC approval
dates for starting materials, raw materials, supplies and reagents, and dates
of cleaning and calibration
of equipment.
Day 1: Manufacturing Instructions
This section contains the step by step instructions for the process performed
on Day 1 in sequential
order. There should be blanks for all information and data to be entered and
spaces for
signatures, initials and dates. All steps including sampling for QC tests
should be indicated. Many
operations will be recorded by checking a box to indicate the step was
performed. Timed operations
should have a space to fill in the beginning time and the finishing time.
Weighings should

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have a space to record the tared weight and final weight. Any calculations
should be presented as
a formula with blanks to fill in. All critical steps and blanks for times and
weights and all calculations
should have an additional blank space for the initials of second operator
who verifies the
reading or calculation. If an item of measuring equipment has a printed
readout, the verification
signature is not necessary, but the printout must be attached to the record
as well as the value
entered in the appropriate blank on the record.
Day 1: Cleanup
A checklist of the step-by-step instructions for the procedure for cleaning up
after the days production
is completed including: waste disposal, removal of reagents, storage of
intermediates if appropriate,
status of equipment, cleaning procedures performed before leaving. Blanks
and
checkboxes and spaces for signatures, initials and dates are on the
checklist.
Day 1: Reporting
The days record is delivered to the Production manager at the end of the
day.
Day 2: Preparation
Preparation information for the steps for the continuation of the fermentation
process performed
on the second day are to be provided in a checklist with all the appropriate
information (see day 1).
Supplies and reagents brought in for day 2, and any calibrations, cleaning or
preparation of equipment
done on day 2 must be entered on the checklist.
Day 2: Manufacturing Instructions
Continued step-by-step instructions for all the steps of the process
performed on day 2, blanks
and checkboxes for entering data, and spaces for signatures, initials and
dates.
Day 2: Cleanup
A checklist of the step-by-step instructions for the procedure for cleaning up
after the days production
is completed including: waste disposal, removal of reagents, storage of
intermediates if appropriate,
status of equipment, cleaning procedures performed before leaving Blanks
and
checkboxes and spaces for signatures, initials and dates are on the
checklist.
Day 2: Reporting
The day’s record is delivered to the Production Manager at the end of the day.

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RABIES VACCINE UNIT

The Production Manager reviews and signs each page of the record in the appropriate blanks.
This format continues for the full number of days for this fermentation part of the
production process. The batch for fermentation will end with the storage of the single
or pooled harvests, depending on the manufacturing process.
Preparation information for the steps for the continuation of the fermentation process performed
on the last day are to be provided.
Supplies and reagents brought in for the last day, and any calibrations, cleaning or preparation of
equipment done on the last day must be entered on a checklist.
Day X: Manufacturing Instructions
Similar step-by-step instructions for the procedure for the final day’s processing, blanks and
checkboxes for entering data, and spaces for signatures, initials and dates.
The final step will be the sampling of the batch to send to the QC department for testing and the
instructions for labelling and quarantine storage of the finished fermentation batch (single or pooled
harvests).
Day X: Cleanup
A checklist of the step-by-step instructions for the procedure for cleaning up
after the days production
is completed including waste disposal, removal of reagents, storage of
intermediates if appropriate,
status of equipment, cleaning procedures performed before leaving. There
should be blanks
and checkboxes for entering data, and spaces for signatures, initials and
dates.
Day X: Reporting
The day’s record is delivered to the Production Manager at the end of the
day. The Production
Manager reviews and signs each page of the record.
PART 2 . INFECTION

PART 3 INACTIVATION

PART 4 CONCENTARTION

PART 5 ADJUVANISATION

PART 6 TITARTION

PART 7 FILLING AND LABELLING

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SOP FOR THE CALIBRATION OF FOLLOWING EQUIPMENTS

PH meters

Pressure gauges

Thermometers

Anemometers

Humidity meters

Vacuum pumps

Time controllers

Filling machine

Automatic pipetting devices

Water conductivity meters

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