QUALITY ASSURANCE PROCESS VALIDATION PROTOCOL FOR PARENTERALS Protocol No. : Rev. :00 Supersedes: NIL Protocol prepared on: Effective Date: Page 1 of 30 Prepared By Reviewed by Approved by Designation Date Format No.: PROCESS VALIDATION PROTOCOL FOR PARENTERALS Protocol No. : Effective Date. :
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QUALITY ASSURANCE
PROCESS VALIDATION PROTOCOL FOR PARENTERALS
Protocol No. :
Rev. :00
Supersedes: NIL
Protocol prepared on:
Effective Date:
Page 1 of 30
Prepared By Reviewed by Approved by
Designation
Date
Format No.:
PROCESS VALIDATION
PROTOCOL FOR PARENTERALS
Protocol No.
:
Effective Date. :
QUALITY ASSURANCE
PROCESS VALIDATION PROTOCOL FOR PARENTERALS
Protocol No. :
Rev. :00
Supersedes: NIL
Protocol prepared on:
Effective Date:
Page 2 of 30
Prepared By Reviewed by Approved by
Designation
Date
Format No.:
TABLE OF CONTENTS
S.NO. SECTION Page No
1. Protocol approval
2. Purpose
3. Responsibilities
4. Requirements
5. Personnel Responsibilities
6. Validation parameters
7. Limits
8. Conclusion report
QUALITY ASSURANCE
PROCESS VALIDATION PROTOCOL FOR PARENTERALS
Protocol No. :
Rev. :00
Supersedes: NIL
Protocol prepared on:
Effective Date:
Page 3 of 30
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1. PROTOCOL APPROVAL
This document is prepared by the validation and the GMP compliance (QA) team of ______________under the authority of _____________. Hence this document before being effective shall be approved by ____________________.
Designation
Name
Signature
Date
QUALITY ASSURANCE
PROCESS VALIDATION PROTOCOL FOR PARENTERALS
Protocol No. :
Rev. :00
Supersedes: NIL
Protocol prepared on:
Effective Date:
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2. PURPOSE Process validation is establishing documented evidence which provides a high degree of assurance that a specific process (such as manufacturer of pharmaceutical dosages forms) will consistently produce a product meeting its predetermined specifications and quantity characteristics.
3. RESPONSIBILITIES
4. REQUIRMENTS: NIL
5. PERSONNEL RESPONSIBILITIES:
The perfect validation program necessitates various departments’ involvement mainly to balance the total
system functioning for its effective utilization for success criteria compliance on regular basis. Quality assurance
department initiates validation program with protocol, specified procedure and success criteria. Quality control
personnel are responsible for the validation run as per the protocol and during validation maintenance
departments have to cooperate to the quality control personnel.
The process validation will be performed as prospective validation. The complete documentation for the
validation comprises several independent documents; references to relevant documents will be given as part of
this protocol, (find below). The results of the validation activities will be summarized in the validation report.
QUALITY ASSURANCE
PROCESS VALIDATION PROTOCOL FOR PARENTERALS
Protocol No. :
Rev. :00
Supersedes: NIL
Protocol prepared on:
Effective Date:
Page 6 of 30
Prepared By Reviewed by Approved by
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Format No.:
List of Documents for Validation:
Validation protocol,
Details of sampling for the validation batches, test parameters (Product performance characteristics) with
reference to test methods & Acceptance criteria. (acceptable Limit)
Methods for recording / evaluating results including statistical analysis.
Reference to relevant documents.
Batch manufacturing records.
Detailed manufacturing instructions for the production of the validation batches.
Process Description / Flow Sheet
The information given below provides a general description of the process. Detailed information for the manufacturing will be supplied separately in the Batch Processing Record. 1 Prepare production order and according to that issue the BPR
2 RM dispensing as per Bill of material 3 Input checks in presence of QA person
4 De-cartoning of vials and rubber stoppers 5 Washing and Sterilization 5.1 vial washing
5.2 Sterilization of vials by DHS 5.3 Rubber stoppers washing 5.4 Steam heat sterilization of rubber stoppers, Garments and Machine parts. 6 Manufacturing/ Batch preparation 7 pH adjustment and volume makeup 8 Filtration 9 Vial filling 10 Lyophilization 11 Vials sealing 12 Optical inspections 13 Vials packing
QUALITY ASSURANCE
PROCESS VALIDATION PROTOCOL FOR PARENTERALS
Protocol No. :
Rev. :00
Supersedes: NIL
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FLOW SHEET:
Sampling point
Input check in presence of QA person De-cartooning
Washing and sterilization Filtration
Prepare production order and according to that issue the BPR
RM dispensing as per Bill of material
Manufacturing
Vials filling Lyophilization
Vials sealing
Optical Inspections
pH Adjustment and volume makeup
Vials packing
QUALITY ASSURANCE
PROCESS VALIDATION PROTOCOL FOR PARENTERALS
Protocol No. :
Rev. :00
Supersedes: NIL
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Effective Date:
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FORMULATION:
Batch Size:
Sr No Ingredients
Unit per
ml
Quantity in Kgs
Overages
Quantity with
Overages
Dispensed Quantity
Function
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
QUALITY ASSURANCE
PROCESS VALIDATION PROTOCOL FOR PARENTERALS
Protocol No. :
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Equipments/ Factory
A detailed list of equipment used for validation together with the cleaning status will be provided in the manufacturing documents. List of SOP’S, Validation & Qualification report used as references
Procedure: Labeling should be as per the specifications. Method reference: Leak test procedure for Sealed vials.
Stage
No of vials tested
Position of label
After machine Setting
Beginning of Setting
Middle of Setting
At the end of Setting
QUALITY ASSURANCE
PROCESS VALIDATION PROTOCOL FOR PARENTERALS
Protocol No. :
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Supersedes: NIL
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Data recording-10 Analysis Report
Product Name:
Batch No.: Batch size:
Mfg. Date: Exp. Date:
Composition:
Test method reference: In house
Sr. No. Test Specification Results Remark
01 Description
02 pH
03 Specific Gravity
04 Uniformity Of volume
05 Assay
5.1 % Labeled amount: 90 % - 110 %
Quantity Found:
5.2 % Labeled amount: 90 % - 110 %
Quantity Found:
5.3 % Labeled amount: 90 % - 110 %
Quantity Found:
5.4 % Labeled amount: 90 % - 110 %
Quantity Found:
Remark:
Result: The sample referred above complies / does not comply with the standard prescribed as per In house
Specification.
QUALITY ASSURANCE
PROCESS VALIDATION PROTOCOL FOR PARENTERALS
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Supersedes: NIL
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Data recording 10
Sr
No
Name of critical equipment / Utilities Qualification /
Validation file
reference No
Date of Qualification /
Validation
1 S.S. Manufacturing tank
3 Membrane Filter
4 Filtration tank
5 Washing Machine
6 Filling Machine
7 Lyophilization
8 Sealing Machine
9 Labeling Machine
Utilities:
1 AHU System
2 Water System
3 Compressed Air
4 Steam
5 Lightning
6 Drain
QUALITY ASSURANCE
PROCESS VALIDATION PROTOCOL FOR PARENTERALS
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Data recording 11
Remark:
Attach Analytical Method Validation protocol
QUALITY ASSURANCE
PROCESS VALIDATION PROTOCOL FOR PARENTERALS
Protocol No. :
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Supersedes: NIL
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Conclusion
Sr. No. Stage Acceptance criteria Observation
1. Manufacturing Complies as per BPR
2. Vial Washing Complies as per BPR
3. Rubber stopper
washing
Complies as per BPR
4. Filling Complies as per BPR
5. Lyophilization Complies as per BPR
6. Sealing Leak test
7. Labeling and
packing
Complies as per BPR
Conclusion:
Product _______________________manufactured as per B.M.R. No _____________ meets predefined
acceptance criteria.
Analysis By Approved By
Date Date
QUALITY ASSURANCE
PROCESS VALIDATION PROTOCOL FOR PARENTERALS
Protocol No. :
Rev. :00
Supersedes: NIL
Protocol prepared on:
Effective Date:
Page 30 of 30
Prepared By Reviewed by Approved by
Designation
Date
Format No.:
7. LIMIT: Based on respective Standard Testing Procedures. 8. CONCLUSION REPORT
Summary report will contain discussion and conclusion , which clearly states the successful achievement of objective of validation studies and recommended concentrations required for sanitisation, disinfections and equipment sanitization.
Note: Extra pages for conclusions can be used as per requirement.