Standard Operating Procedure for Visual Inspection Post Cleaning in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/171/2025 |
| Supersedes | SOP/ELX/171/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the procedure for conducting visual inspection of equipment, utensils, and product-contact surfaces after cleaning, ensuring removal of visible residues and suitability for next use in elixir manufacturing.
2. Scope
This SOP applies to all cleaned and rinsed equipment, tanks, pipelines, filling machines, accessories, and utensils within the Elixir Department that require visual verification before use or further testing.
3. Responsibilities
- Production Operator:
- Perform preliminary visual inspection and report any non-conformities.
- QA Officer:
- Carry out formal visual inspection under suitable lighting conditions.
- Approve or reject equipment for further processing.
4. Accountability
The Production Head is accountable for ensuring that visual inspection is conducted post-cleaning. The QA Head ensures documented verification and compliance with acceptance criteria.
5. Procedure
5.1 Preparation for Inspection
- Ensure that the cleaning process has been completed
and documented.
Verify that rinse water meets pH, conductivity, and TOC requirements (if applicable).
Ensure adequate lighting is available for internal and external surface examination (minimum 540 lux for open areas and 1080 lux for interior inspection).
5.2 Visual Inspection Process
- Inspect all product-contact surfaces for the presence of:
- Residues (powder, liquids, color stains, sticky mass)
- Fibers or lint from cleaning cloths
- Water droplets or standing water
- Corrosion, cracks, dents, or discoloration
- Inspect critical areas such as:
- Bottom valves, nozzles, manways
- Gasket grooves and crevices
- Joints and connections
- Use inspection mirrors and flashlights where required for internal surfaces.
- If any residue is observed, inform the Production Head and initiate re-cleaning before reinspection.
5.3 Documentation
- Record inspection findings in the Visual Inspection Logbook (Annexure-1).
- Include details such as date, equipment ID, type of inspection, performed by, observations, and QA decision.
- Label equipment as “VISUALLY CLEANED – APPROVED” or “REJECTED – TO BE RE-CLEANED.”
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- TOC: Total Organic Carbon
7. Documents
- Visual Inspection Logbook (Annexure-1)
- Cleaning Record Sheet
- QA Verification Checklist
8. References
- 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
- ICH Q7 – GMP Guidelines for APIs
- WHO TRS 986 Annex 4 – 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 Logbook
| Date | Equipment ID | Type of Inspection | Inspected By | QA Verified | Status | Remarks |
|---|---|---|---|---|---|---|
| 11/04/2025 | MXR-ELX-12 | Post-Cleaning | Rajesh Kumar | Sunita Reddy | Approved | Visually Clean |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Included lux requirement and critical point checklist | Audit Enhancement | QA Head |