Procedure for Handling Revalidation Requirements
| Department | Quality Assurance (QA)/Validation/Production |
|---|---|
| SOP No. | SOP/Ointment/120 |
| 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 process for handling revalidation requirements in ointment manufacturing. This ensures continued compliance with Good Manufacturing Practices (GMP), regulatory guidelines, and internal quality standards.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Validation, and Production departments responsible for scheduling, executing, and documenting revalidation activities.
3. Responsibilities
- QA Officer: Ensures revalidation activities align with regulatory requirements.
- Validation Team: Conducts revalidation studies and records findings.
- Production Supervisor: Ensures adherence to revalidated processes.
- Engineering Team: Supports revalidation of equipment and utilities.
- QA Manager: Approves revalidation reports and ensures implementation.
4. Accountability
The QA and Validation Managers are accountable for ensuring that revalidation is conducted as per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Types of Revalidation
- Periodic Revalidation: Conducted at predefined intervals (e.g., every 3 years).
- Change-Based Revalidation: Required after significant changes such as:
- Equipment replacement or modification
- Process parameter adjustments
- Facility or utility changes
- Raw material or formulation modifications
- Regulatory-Driven Revalidation: Required due to updated regulations or audit findings.
5.2 Revalidation Planning and Documentation
- Develop a Revalidation Master Plan (RMP) detailing:
- Scope and frequency of revalidation
- Acceptance criteria and regulatory standards
- Documentation and approval process
- Ensure revalidation protocols and reports are reviewed before execution.
5.3 Execution of Revalidation Studies
- Perform revalidation under controlled conditions.
- Ensure all data and observations are recorded in real-time.
- Identify and document any deviations during revalidation execution.
5.4 Compliance Monitoring
- QA must verify adherence to revalidated processes.
- Gap analysis should be conducted to identify non-conformances.
- Corrective and preventive actions (CAPA) must be implemented if needed.
5.5 Handling Deviations
- Investigate the root causes of deviations.
- Document corrective actions taken.
- Repeat revalidation if necessary and update validation reports.
5.6 Regulatory Audits and Compliance Checks
- Ensure all revalidation documents are audit-ready.
- QA and Regulatory Affairs must prepare responses to regulatory inquiries.
- Periodic internal audits should verify compliance with revalidation requirements.
5.7 Approval and Documentation
- Summarize revalidation results, compliance status, and any deviations.
- Obtain final approval from the QA Manager.
- Maintain revalidation records for regulatory audits.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- CAPA – Corrective and Preventive Action
- ICH – International Council for Harmonisation
- FDA – Food and Drug Administration
7. Documents
- Revalidation Master Plan (Annexure-1)
- Revalidation Checklist (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice Guide
- WHO Guidelines for Revalidation
- US FDA Guidance on Process Revalidation
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Revalidation Master Plan
| Revalidation Type | Frequency | Approval Required |
|---|---|---|
| Process Revalidation | Every 3 years | QA Manager |
| Cleaning Revalidation | Annually | QA Manager |
| Equipment Revalidation | As needed | Engineering Manager |
Annexure-2: Revalidation Compliance Checklist
| Revalidation Parameter | Status | Comments |
|---|---|---|
| All protocols approved before execution | Yes | – |
| Deviations documented | Yes | Reviewed and addressed |
| Regulatory audit readiness | Yes | Compliant |
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 |