Validation Protocols for the Rabies Laboratory

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 1. Domestic sanitary sewer systems 2. Process drain systems 3. Hazardous waste systems 4. Solid waste disposal systems 5. Hazardous emissions systems

B. Air Handling Systems (IQ/OQ/PQ) 1. Heating system 2. Ventilation system 3. Air conditioning system 4. Air filter systems 5. Biological safety cabinets

C. Water System (IQ/OQ/PQ) 1. Purified water 2. Water for injection (WFI) 3. Source potable water

6. Laminar flow hoods D. Steam Systems (IQ/OQ/PQ) 1. Plant steam (raw steam) 2. Clean steam G. Electrical System (IQ/OQ) 1. Electrical standard 2. Electrical emergency power 3. Electrical back-up power

E. Cooling Systems (IQ/OQ/PQ) 1. Chillers 2. Cooling towers H. Equipment(IQ/OQ) 1. Production 2. Quality control laboratory

J. Cleaning Processes 1. CIP (Clean-in-Place) process a. Aseptic b. Non-aseptic 2. SIP (Sterilize-in-Place) process 3. Facility cleaning processes a. Equipment b. Clean area c. Aseptic area d. Sanitization e. Garment laundering f. General facility cleaning (janitorial)

K. Component Preparation Equipment 1. Container washing equipment (IQ/OQ/PQ) a. Manual b. Semi-automatic (programmable controllers) c. Automatic (computer controlled) 2. Closure washing equipment (IQ/OQ/PQ) a. Manual b. Semi-automatic (programmable controllers) c. Automatic (computer controlled) 3. Washing/depyrogenation/sterilization processes N. Finishing 1. Labeling process a. Manual b. Semi-automatic c. Automatic 2. Packaging (boxing) process

M. Sterile Filling (Aseptic or Terminally Sterilized) 1. Solution filling a. Manual b. Automatic 3. Container sealing a. Manual vial stoppering b. Automatic vial stoppering c. Ampoule sealing 4. Container capping

P. Storage/Warehouse Operations (Storage, Holding, Distribution) 1. Incoming/Receiving 2. Warehousing 3. In process storage 4. Approved finished goods storage 5. Outgoing/distribution/shipping

Q. Analytical Methods 1. Raw materials 2. In-process product 3. Intermediates 4. Final product

F. Gas Systems (IQ/OQ/PQ) CO2 I. Sterilization 1. Steam sterilization (autoclaves)(IQ/OQ/PQ) a. Component preparation sterilizer b. Terminal sterilizer c. Laboratory sterilizer 2. Dry heat sterilization/depyrogenation (IQ/OQ/PQ) b. Ovens 3. Terminal filtration process L Aseptic Solution Preparation 1. Solution manufacture process 2. Solution filtration process

O. Manufacturing Processes 1. Cell separation 2. Cell growth a. Roller bottle 3. Buffer preparation a. Buffer weigh-up. b. Buffer preparation i. Sterile filtration ii. Sterilization c. Buffer storage 4. ultrafiltration a. inactivation b. adjuvanisation R. Other 2. Vendor validation/supplier audit 3. Animals a. Animal care and handling processes b. Supplier validation (audit)

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RABIES VACCINE UNIT

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 Page ………of………

RABIES VACCINE UNIT

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


RABIES VACCINE UNIT


RABIES VACCINE UNIT

Validation protocol No. Title: MASTER VALIDATION PLAN Written by: Revised by: Revision No.:

effective date Edited by: Section: 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


RABIES VACCINE UNIT

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 Page ………of………

RABIES VACCINE UNIT

REFERENCE DOCUMENTS

MANUFACTURER’S COMMUNICATION


RABIES VACCINE UNIT

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

B

Model

Serial No.

Manufacture’s address

Suppliers address

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 1

Required/ordered

Actual

Deviations

MODEL/SERIAL No.


RABIES VACCINE UNIT 2 3 4 5 6 7

Specifications Manual/booklet Drawing Wiring/cabling Power, fusing Operation SOP, maintenance SOP calibration SOP Input/output control Environmental requirement Test equipment or instrument Utilities and services Spare part list, part No. and supplier Others

8 9 10 11 12 13

DEVIATION REPORT Deviation(s):

Justification for acceptance:

Impact on operation:

PHYSICAL DETAILS Serial No. 1 2 3 4 5 6 7

Description Overall dimension Weight Colour code Surface finish Motor/gear box/pulleys etc Electrical rating Details of auxiliary equipments

Particulars

SOP s FUNCTION

SOP No.

Date of issue

Revision no & date

Title

Next revision

CALIBRATION REVIEW


RABIES VACCINE UNIT Process instrument

Location

Test instrument

Location

Date of calibration

Date of calibration

Calibrated by

Calibrated by

Checked by

Checked by

Next calibration due on

Next calibration due on

Component to be calibrated

SYSTEM / INSTRUMENT CHECK LIST Sl. No.

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

YES/NO

Observed by

Date

DRAWINGS Sl.

Drawing

Category

Location

Drawing No

Date

No.

Physical 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


RABIES VACCINE UNIT

RESULTS:

CONCLUSIONS

Report Written by: ______________________________________________ Date ___________ QA approved by: ________________________________________________ Date ___________


RABIES VACCINE UNIT

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 Page ………of………

RABIES VACCINE UNIT SOP Title

Number

File Location

QA/QC approval date

TRAINING RECORDS Course on SOP #

Staff name

Equipment Make

Model

Date

Manual Available (Y/N)

Performed by: ______________________________________________ Date _______________ Deviations: Verified by: ________________________________________________ Date ________________ Results

CONTROL PANEL FUNCTIONALITY Purpose Testing Functionality test results Equipment

Make

Serial no.

No

Location of

Control panel

Location of

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)


RABIES VACCINE UNIT extreme temperature

Pressure considerations

Hot line/equipment insulated Personal protection available Heat source identified and shielded Sign post to alert operations 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 nature

Material safety data sheet (MSDS) 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


RABIES VACCINE UNIT Ergonomic design

Dust level

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 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 ________________


RABIES VACCINE UNIT

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 ________________


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


RABIES VACCINE UNIT

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


RABIES VACCINE UNIT 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 ___________


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 ___________


RABIES VACCINE UNIT

Validation protocol No. 1 Title: Written by: Revised by: Revision No.: OBJECTIVE:

PROCESS VALIDATION Edited by: Section: Effective date:

Revision date:

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.


RABIES VACCINE UNIT 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 _____________


JUSTIFICATION FOR ACCEPTANCE: Impact on process: Supervisor: _____________________________________________________ Date _________

PROCESS VALIDATION REPORT Results: Conclusions: Written by: _____________________________________________ Date _____________ QA approved by: ________________________________________ Date ____________


RABIES VACCINE UNIT

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 Page ………of………

RABIES VACCINE UNIT 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:


RABIES VACCINE UNIT

Written by: ________________________________________________ Date _________

ASSAY VALIDATION REPORT

Results:

CONCLUSIONS:

Written by: _____________________________________________ Date _____________ QA approved by: _________________________________________


RABIES VACCINE UNIT

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:


RABIES VACCINE UNIT

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.


RABIES VACCINE UNIT

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


RABIES VACCINE UNIT

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.


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


RABIES VACCINE UNIT

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


Validation Protocols for the Rabies Laboratory

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