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Standard Operating Procedure (SOP)
Process Validation
1. Purpose
To establish a standard procedure for performing process validation activities for
pharmaceutical manufacturing processes.
2. Scope
This SOP applies to all new and existing manufacturing processes requiring validation in the
facility.
3. Definitions
- Process Validation: Documented evidence that a process operates effectively and
reproducibly to produce a product meeting its predetermined specifications and quality
attributes.
4. Responsibilities
- Validation Team: Prepare and execute validation protocols
- Production: Execute runs as per approved protocol
- QA: Review and approve all validation documentation
5. Types of Process Validation
- Prospective Validation
- Concurrent Validation
- Retrospective Validation
- Re-validation
6. Procedure
6.1 Develop a Validation Master Plan (VMP)
6.2 Define critical quality attributes (CQAs)
6.3 Prepare process validation protocol
6.4 Execute protocol including sampling and testing
6.5 Analyze results and deviations
6.6 Prepare process validation report
7. Documentation and Records
- Validation Master Plan
- Validation Protocols and Reports
- Batch Manufacturing Records (BMRs)
- Analytical Test Results
8. Deviations and CAPA
Any deviation must be documented and evaluated. CAPA must be initiated where
applicable.
9. References
- FDA Guidance for Industry: Process Validation
- EU GMP Annex 15
- ICH Q8/Q9/Q10
10. Appendices
- Sample Validation Protocol
- Process Validation Report Template
Appendix A - Sample Process Validation Protocol
1. Objective
2. Scope
3. Responsibilities
4. Process Description
5. Critical Parameters
6. Sampling Plan
7. Acceptance Criteria
8. Data Collection Forms
9. Approval Page
Appendix B - Process Validation Report Template
1. Protocol Number
2. Execution Dates
3. Summary of Batches
4. Results and Graphs
5. Deviations
6. Conclusion
7. Approval Page
