Procedure for Documentation of Cleaning Validation
| Department | Quality Assurance (QA)/Validation/Quality Control (QC)/Production |
|---|---|
| SOP No. | SOP/Ointment/128 |
| 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 documentation of cleaning validation in ointment manufacturing. Proper documentation ensures compliance with regulatory requirements, traceability, and verification of cleaning effectiveness.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Validation, Quality Control (QC), and Production departments responsible for documenting cleaning validation activities and maintaining records.
3. Responsibilities
- QA Officer: Ensures proper documentation of cleaning validation activities.
- Validation Team: Develops and maintains cleaning validation documents.
- QC Analyst: Records analytical test results for residue analysis.
- Production Supervisor: Documents cleaning process and ensures compliance.
- QA Manager: Reviews and approves cleaning validation records.
4. Accountability
The QA and Validation Managers are accountable for ensuring that cleaning validation documentation is maintained as per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Types of Cleaning Validation Documents
- Cleaning Validation Master Plan (CVMP)
- Cleaning Validation Protocols (CVP)
- Cleaning Validation Reports (CVR)
- Swab and Rinse Sample Records
- Analytical Test Reports
- Deviation and CAPA Reports
5.2 Documentation of Cleaning Validation Activities
- Maintain cleaning validation records in a structured manner.
- Ensure each record includes:
- Equipment and material details
- Cleaning method used
- Sampling
locations
Acceptance criteria
Assign a unique identification number to each validation document.
5.3 Review and Approval of Cleaning Validation Documents
- QA must review all cleaning validation records for accuracy and completeness.
- QC must verify analytical test results.
- QA Manager must approve all cleaning validation reports.
5.4 Storage and Retention of Cleaning Validation Documents
- Store validation documents in a secure and accessible location.
- Retain documents as per regulatory retention policies.
- Ensure validation records are available for regulatory audits.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- CVMP – Cleaning Validation Master Plan
- CVP – Cleaning Validation Protocol
- CVR – Cleaning Validation Report
7. Documents
- Cleaning Validation Record Log (Annexure-1)
- Cleaning Validation Approval Report (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice Guide
- WHO Guidelines for Cleaning Validation
- US FDA Guidance on Cleaning Validation Documentation
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Cleaning Validation Record Log
| Date | Equipment ID | Cleaning Method | Test Performed | Result | Reviewed By |
|---|---|---|---|---|---|
| 01/02/2025 | MIX-1001 | Standard Cleaning | TOC Analysis | Pass | QA Manager |
| 02/02/2025 | FILL-2002 | Validated Cleaning | HPLC | Pass | QA Manager |
Annexure-2: Cleaning Validation Approval Report
| Validation ID | Validation Type | Approval Date | Final Status | Approved By |
|---|---|---|---|---|
| CV-2025-001 | Routine Cleaning Validation | 01/02/2025 | Approved | QA Manager |
| CV-2025-002 | Change Control Validation | 05/02/2025 | Approved | QA Manager |
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 |