Procedure for Filing Validation Protocols
| Department | Quality Assurance (QA)/Validation/Quality Control (QC)/Production |
|---|---|
| SOP No. | SOP/Ointment/157 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for filing validation protocols in pharmaceutical manufacturing. Proper documentation of validation protocols ensures compliance with Good Manufacturing Practices (GMP), regulatory requirements, and traceability for audits and inspections.
2. Scope
This SOP applies to personnel in the Quality Assurance (QA), Validation, Quality Control (QC), and Production departments responsible for preparing, reviewing, and filing validation protocols for processes, equipment, and systems.
3. Responsibilities
- Validation Officer: Prepares and reviews validation protocols for processes, equipment, and facilities.
- QA Officer: Ensures proper documentation and filing of validation protocols.
- QC Analyst: Verifies compliance with validation requirements.
- QA Manager: Approves and ensures compliance with validation protocols.
4. Accountability
The QA and Validation Managers are accountable for ensuring that validation protocols are prepared, filed, and maintained in compliance with GMP, FDA, ICH, and WHO regulations.
5. Procedure
5.1 Types of Validation Protocols
The following types of validation protocols must be maintained:
- Process Validation Protocol: Documents procedures to validate manufacturing processes.
- Equipment Qualification Protocol: Defines the qualification process for equipment (IQ, OQ, PQ).
- Cleaning Validation Protocol: Establishes procedures for
verifying cleaning effectiveness.
Analytical Method Validation Protocol: Ensures analytical methods provide reliable test results.
Computer System Validation Protocol: Verifies compliance of computerized systems used in manufacturing.
5.2 Preparation of Validation Protocols
- The Validation Officer must draft validation protocols based on regulatory and organizational requirements.
- Protocols must include:
- Objective and scope of validation.
- Validation approach and acceptance criteria.
- Equipment and materials required.
- Execution plan and responsibilities.
- Data collection methods and report format.
- Protocols must be reviewed and approved by the QA Manager before implementation.
5.3 Filing and Documentation of Validation Protocols
- Validation protocols must be assigned a unique identification number.
- Each protocol must be stored in a **Validation Master File (VMF).**
- Filing must be categorized based on validation type (Process, Equipment, Cleaning, Analytical, Computerized Systems).
- Electronic copies must be stored in a **secured document management system** with controlled access.
5.4 Implementation and Execution of Validation Protocols
- QA must ensure that validation protocols are followed during execution.
- All test results must be recorded in a **Validation Execution Report**.
- Any deviations or failures must be documented and investigated.
5.5 Review and Approval of Validation Reports
- QA must review validation execution reports for compliance.
- Final validation reports must be signed off by the QA Manager.
- Validation records must be **archived for a minimum of 5 years.**
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- VMF – Validation Master File
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance Qualification
- FDA – Food and Drug Administration
- ICH – International Council for Harmonisation
7. Documents
- Validation Protocol Template (Annexure-1)
- Validation Execution Report Template (Annexure-2)
8. References
- ICH Q2 – Validation of Analytical Procedures
- WHO Guidelines on Process Validation
- US FDA Guidance on Validation Principles
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Validation Protocol Template
| Protocol No. | Validation Type | Objective | Execution Plan | QA Approval |
|---|---|---|---|---|
| VP-001 | Process Validation | Validate Ointment Mixing | 3 Batch Runs | Approved |
Annexure-2: Validation Execution Report Template
| Date | Validation Type | Results | Deviations | QA Review |
|---|---|---|---|---|
| 02/02/2025 | Cleaning Validation | Pass | None | Reviewed |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 02/02/2025 | 2.0 | Expanded Procedure | Improved Documentation | QA Head |