Procedure for Visual Inspection After Cleaning
| Department | Quality Assurance (QA)/Validation/Production |
|---|---|
| SOP No. | SOP/Ointment/123 |
| 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 conducting visual inspection after cleaning in ointment manufacturing. This ensures that cleaning procedures effectively remove visible residues, preventing cross-contamination and ensuring compliance with regulatory standards.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Validation, and Production departments responsible for performing and documenting visual inspections after cleaning.
3. Responsibilities
- QA Officer: Conducts and verifies visual inspections.
- Production Supervisor: Ensures that equipment is visually clean before use.
- Validation Team: Establishes visual inspection criteria.
- QC Analyst: Supports inspections by correlating findings with analytical testing.
- QA Manager: Approves visual inspection reports and ensures compliance.
4. Accountability
The QA and Validation Managers are accountable for ensuring that visual inspection is conducted as per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Preparation for Visual Inspection
- Ensure that all cleaning activities are completed before inspection.
- Review the cleaning checklist for the specific equipment or area.
- Assign trained personnel to conduct visual inspections.
- Ensure adequate lighting conditions and access to inspection areas.
5.2 Execution of Visual Inspection
- Inspect all equipment surfaces, including hard-to-reach areas.
- Look
for visible residues such as:
Use a UV light or magnifying glass if required for detailed inspection.
Document findings on the Visual Inspection Log.
- Powder or liquid residues
- Streaks or smudges
- Oily or greasy deposits
- Water spots or detergent residues
5.3 Acceptance Criteria
- No visible residues should remain on any surface.
- Equipment must appear dry and free from cleaning agent residues.
- All disassembled parts should be clean before reassembly.
5.4 Handling Deviations
- If residues are detected, inform the Production Supervisor immediately.
- Initiate re-cleaning and document corrective actions.
- Re-perform visual inspection after corrective measures.
5.5 Documentation and Approval
- QA must review and approve all visual inspection reports.
- Records must be retained for regulatory audits.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- FDA – Food and Drug Administration
- ICH – International Council for Harmonisation
7. Documents
- Visual Inspection Checklist (Annexure-1)
- Visual Inspection 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: Visual Inspection Checklist
| Inspection Area | Criteria | Pass/Fail |
|---|---|---|
| Mixing Tank Interior | No visible residues | Pass |
| Filling Machine Nozzles | Free from blockage | Pass |
| Piping and Valves | No streaks or deposits | Pass |
Annexure-2: Visual Inspection Log
| Date | Equipment ID | Inspector Name | Findings | Corrective Action | Reviewed By |
|---|---|---|---|---|---|
| 01/02/2025 | MIX-1001 | John Doe | Clean | None | QA Manager |
| 02/02/2025 | FILL-2002 | Jane Smith | Residue found | Re-cleaned | 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 |