Standard Operating Procedure for Validation Protocol Review and Approval
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/191/2025 |
| Supersedes | SOP/TAB/191/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
This SOP describes the process for reviewing and approving validation protocols in tablet manufacturing, ensuring that all validation activities are in compliance with regulatory standards and are conducted systematically to ensure product quality and safety.
2. Scope
This SOP applies to the review and approval of all validation protocols related to tablet manufacturing processes, including but not limited to equipment validation, cleaning validation, process validation, and computer system validation.
3. Responsibilities
- Quality Assurance (QA): Responsible for reviewing and approving all validation protocols to ensure compliance with regulatory requirements and internal standards.
- Validation Team: Responsible for preparing validation protocols and ensuring that they are reviewed and approved prior to the commencement of any validation activities.
- Regulatory Affairs: Responsible for ensuring that validation protocols are aligned with applicable regulatory guidelines and requirements.
- Production Team: Responsible for executing the validated processes and ensuring that validation activities are adhered to during production.
4. Accountability
The QA Manager is accountable for ensuring that all validation protocols are reviewed, approved, and documented in accordance with this SOP. The Validation Team Leader is accountable for ensuring that validation protocols are accurately prepared for review and approval.
5. Procedure
5.1 Validation Protocol Preparation
- The Validation Team prepares a protocol for validation activities, including the objectives, scope, methodology, acceptance criteria, and timelines for each validation project.
- The protocol should include a risk-based approach to validation, considering the criticality of the equipment or process being validated and the potential impact on product quality.
- Ensure that the protocol is aligned with regulatory requirements (e.g., FDA, EMA) and internal standards.
5.2 Protocol Review
- The protocol should be submitted to the QA team for review. The review process should ensure that all necessary information is included and that the protocol complies with applicable guidelines and standards.
- QA personnel should review the protocol for clarity, completeness, and compliance with GMP and regulatory requirements.
- If required, the QA team may request modifications or clarifications before approving the protocol. All feedback must be documented.
5.3 Protocol Approval
- Once the protocol has been reviewed and any necessary changes have been made, the protocol should be formally approved by the QA Manager and the Validation Team Leader.
- Ensure that all approvals are documented, and the protocol is signed and dated by the individuals responsible for the review and approval.
- Upon approval, the protocol is considered finalized, and validation activities can proceed as per the approved protocol.
5.4 Documentation and Record Keeping
- All validated protocols, including reviewed and approved versions, should be retained in a secure, easily accessible location (either electronic or paper format) for a minimum of five years or as per regulatory requirements.
- Ensure that the validation protocol, any revisions, and related documents (e.g., change control records, validation reports) are properly filed and readily available for audit or inspection purposes.
5.5 Revision of Protocols
- If modifications are needed after the approval of the protocol, a revised version of the protocol must be created and reviewed following the same process outlined in this SOP.
- Ensure that all revisions are clearly documented with an explanation for the change and that the revised protocol is approved before implementation.
5.6 Audit and Compliance
- Conduct periodic audits to ensure that the validation protocols are being followed as intended and that all data generated during validation activities is compliant with regulatory and internal requirements.
- Document all audit findings and ensure that corrective actions are implemented for any non-compliance.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- GMP: Good Manufacturing Practice
- FDA: Food and Drug Administration
7. Documents
- Validation Protocol (Annexure-1)
- Protocol Review and Approval Log (Annexure-2)
- Validation Audit Log (Annexure-3)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ISO 9001 – Quality Management Systems
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
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
| Protocol ID | Protocol Name | Prepared By | Approval Date |
|---|---|---|---|
| VP-001 | Equipment Validation | John Doe | 01/03/2026 |
Annexure-2: Protocol Review and Approval Log
| Review Date | Protocol ID | Reviewer | Approval Status |
|---|---|---|---|
| 01/03/2026 | VP-001 | Jane Smith | Approved |
Annexure-3: Validation Audit Log
| Audit Date | Protocol ID | Auditor | Findings | Corrective Actions |
|---|---|---|---|---|
| 01/03/2026 | VP-001 | John Doe | No discrepancies | N/A |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated validation protocol approval process | Clarified review procedures | QA Head |