Procedure for Reviewing Cleaning Validation Data
| Department | Quality Assurance (QA)/Validation/Quality Control (QC)/Production |
|---|---|
| SOP No. | SOP/Ointment/126 |
| 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 reviewing cleaning validation data in ointment manufacturing. This ensures that cleaning procedures effectively remove residues, comply with regulatory standards, and maintain product safety.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Validation, Quality Control (QC), and Production departments responsible for reviewing, analyzing, and maintaining cleaning validation data.
3. Responsibilities
- QA Officer: Reviews cleaning validation data for compliance with regulatory requirements.
- Validation Team: Collects and compiles cleaning validation data.
- QC Analyst: Conducts analytical testing and reports findings.
- Production Supervisor: Ensures adherence to validated cleaning procedures.
- QA Manager: Approves final validation reports and ensures documentation accuracy.
4. Accountability
The QA and Validation Managers are accountable for ensuring that cleaning validation data is reviewed as per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Collection of Cleaning Validation Data
- Obtain validation data from multiple sources, including:
- Swab sampling results
- Rinse water analysis
- Total Organic Carbon (TOC) testing
- High-Performance Liquid Chromatography (HPLC) reports
- Microbial testing results
- Ensure all data is recorded in cleaning validation log sheets.
- Confirm that test parameters match
predefined acceptance criteria.
5.2 Data Analysis and Interpretation
- Compare residue levels with established limits.
- Identify any trends or deviations in data.
- Assess consistency of validation results across multiple cleaning cycles.
5.3 Handling Deviations and Non-Conformances
- Investigate any data points exceeding acceptance criteria.
- Identify root causes of deviations (e.g., improper cleaning, equipment failure).
- Initiate corrective and preventive actions (CAPA) if necessary.
- Document all deviations and actions taken in the validation report.
5.4 Review and Approval of Cleaning Validation Data
- QA must review all collected data for completeness and accuracy.
- Validation and QC teams must verify analytical test results.
- QA Manager must approve the final validation report before submission.
5.5 Documentation and Record Maintenance
- Maintain validation reports in a controlled document repository.
- Ensure data is readily available for regulatory audits and inspections.
- Retain validation data as per regulatory retention requirements.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- TOC – Total Organic Carbon
- HPLC – High-Performance Liquid Chromatography
7. Documents
- Cleaning Validation Data Log (Annexure-1)
- Cleaning Validation Summary Report (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice Guide
- WHO Guidelines for Cleaning Validation
- US FDA Guidance on Cleaning 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: Cleaning Validation Data Log
| Date | Equipment ID | Test Parameter | Result | Reviewed By |
|---|---|---|---|---|
| 01/02/2025 | MIX-1001 | TOC Analysis | Pass | QA Manager |
| 02/02/2025 | FILL-2002 | HPLC | Pass | QA Manager |
Annexure-2: Cleaning Validation Summary Report
| Equipment ID | Validation Test | Acceptance Criteria | Final Status | Approved By |
|---|---|---|---|---|
| MIX-1001 | TOC Analysis | < 5 ppm | Pass | QA Manager |
| FILL-2002 | HPLC | < 10 ppm | Pass | 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 |