Procedure for Ensuring Validation of All Surfaces
| Department | Quality Assurance (QA)/Validation/Quality Control (QC)/Production |
|---|---|
| SOP No. | SOP/Ointment/130 |
| 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 ensuring validation of all surfaces that come into contact with products, cleaning agents, and environmental conditions in ointment manufacturing. This ensures cleaning effectiveness, prevents cross-contamination, and maintains regulatory compliance.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Validation, Quality Control (QC), and Production departments responsible for validating equipment, workbenches, storage surfaces, and facility areas.
3. Responsibilities
- QA Officer: Ensures validation protocols include all critical surfaces.
- Validation Team: Develops, executes, and maintains surface validation records.
- QC Analyst: Conducts analytical testing on surface swabs and rinse samples.
- Production Supervisor: Ensures adherence to validated cleaning protocols.
- QA Manager: Approves final validation reports and maintains documentation.
4. Accountability
The QA and Validation Managers are accountable for ensuring that all surfaces requiring validation are identified, tested, and validated per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Identification of Surfaces for Validation
- Determine all surfaces requiring validation, including:
- Product contact surfaces (mixing tanks, filling lines, nozzles, storage containers)
- Cleaning agent contact surfaces
- Environmental surfaces (workbenches, floors,
walls, HVAC ducts)
Personnel contact surfaces (gloves, uniforms, equipment handles)
Classify surfaces based on contamination risk levels.
5.2 Validation Methodology
- Select appropriate validation techniques for each surface:
- Swab sampling for product residues
- Rinse sampling for cleaning agent residues
- Total Organic Carbon (TOC) testing for organic contamination
- Microbial testing for environmental monitoring
- Define sampling frequency and locations for each surface type.
5.3 Execution of Surface Validation
- Perform visual inspection before sampling.
- Conduct swab sampling in designated high-risk areas.
- Collect rinse samples from equipment and storage surfaces.
- Submit collected samples to QC for analytical testing.
5.4 Analytical Testing and Compliance
- Analyze swab and rinse samples using:
- HPLC for detecting active pharmaceutical ingredients (APIs)
- TOC analysis for detecting residual organic material
- pH testing for neutralizing agent residues
- Microbial testing for detecting potential contamination
- Compare results with established acceptance limits.
5.5 Handling Deviations
- If any surface fails validation criteria:
- Re-clean the affected area and perform repeat testing.
- Investigate potential sources of contamination.
- Implement corrective and preventive actions (CAPA).
5.6 Documentation and Review
- Record all validation data in the Surface Validation Log.
- QA must review and approve all validation results.
- Maintain validation records for regulatory audits.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- TOC – Total Organic Carbon
- HPLC – High-Performance Liquid Chromatography
7. Documents
- Surface Validation Protocol (Annexure-1)
- Surface Validation Log (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: Surface Validation Protocol
| Surface Type | Sampling Method | Test Performed | Acceptance Criteria |
|---|---|---|---|
| Mixing Tanks | Swab Sampling | HPLC | < 10 ppm API residue |
| Filling Lines | Rinse Sampling | TOC Analysis | < 5 ppm organic residue |
| Storage Containers | Swab Sampling | Microbial Testing | No growth detected |
Annexure-2: Surface Validation Log
| Date | Surface ID | Sampling Method | Test Performed | Result | Reviewed By |
|---|---|---|---|---|---|
| 01/02/2025 | MIX-1001 | Swab | HPLC | Pass | QA Manager |
| 02/02/2025 | FILL-2002 | Rinse | TOC | 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 |