Procedure for Validation Protocol Approval
| Department | Quality Assurance (QA)/Validation/Production |
|---|---|
| SOP No. | SOP/Ointment/118 |
| 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 define the approval process for validation protocols in ointment manufacturing. This ensures that all validation activities are planned, reviewed, and authorized before execution.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Validation, and Production departments responsible for reviewing, approving, and managing validation protocols.
3. Responsibilities
- Validation Officer: Prepares validation protocols and ensures they align with regulatory guidelines.
- QA Officer: Reviews the protocol for completeness and compliance.
- Production Supervisor: Confirms protocol feasibility and operational applicability.
- QA Manager: Approves the protocol before execution.
- Regulatory Affairs (if applicable): Ensures the protocol meets regulatory requirements.
4. Accountability
The QA and Validation Managers are accountable for ensuring that validation protocols are reviewed, approved, and documented as per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Validation Protocol Preparation
- The Validation Officer drafts the validation protocol, including:
- Purpose and scope of validation
- Equipment, materials, and methods used
- Critical parameters and acceptance criteria
- Testing methodology and sampling plan
- Approval section for signatures
- The draft protocol is circulated to QA and Production for initial review.
5.2 Review and Revisions
- QA reviews the protocol to
ensure compliance with regulatory requirements.
Production confirms the feasibility of executing the protocol under routine conditions.
Any necessary revisions are incorporated, and the document is updated.
5.3 Approval Process
- Once finalized, the validation protocol is submitted for approval.
- Signatures are obtained from:
- Validation Officer
- Production Supervisor
- QA Manager
- Regulatory Affairs (if applicable)
- QA retains a master copy of the approved protocol.
5.4 Execution and Monitoring
- The approved protocol is executed as per the defined procedures.
- QA monitors the validation study to ensure adherence to the protocol.
- Any deviations are recorded and assessed.
5.5 Validation Report Preparation
- Upon completion of the validation study, a final report is prepared.
- The report includes:
- Summary of test results
- Deviation records (if any)
- Conclusion and recommendations
- The final validation report undergoes the same approval process as the protocol.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- FDA – Food and Drug Administration
- ICH – International Council for Harmonisation
7. Documents
- Validation Protocol Template (Annexure-1)
- Validation Approval Log (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice Guide
- WHO Guidelines for Validation of Manufacturing Processes
- US FDA Guidance on Process Validation
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
| Section | Description |
|---|---|
| Objective | Defines the purpose of validation |
| Scope | Details the areas covered |
| Acceptance Criteria | Defines critical parameters |
| Testing Methodology | Describes tests performed |
Annexure-2: Validation Approval Log
| Validation Protocol ID | Approval Date | Approved By | Comments |
|---|---|---|---|
| VAL-2025-001 | 01/02/2025 | QA Manager | Approved without changes |
| VAL-2025-002 | 05/02/2025 | QA Manager | Minor revisions incorporated |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |