Standard Operating Procedure for Visual Inspection of Filled Gel Containers Before Packing in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/154/2025 |
| Supersedes | SOP/GM/154/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To describe the procedure for carrying out visual inspection of filled gel containers prior to final packing, ensuring they meet quality standards for physical appearance, labeling, integrity, and cleanliness.
2. Scope
This SOP is applicable to all batches of gel products filled in tubes, jars, or other containers and intended for market release after final visual inspection in the Gel Manufacturing department.
3. Responsibilities
- Production Operator: Performs visual inspection according to defined parameters.
- Production Supervisor: Ensures compliance
with the inspection process and documentation.
Quality Assurance: Monitors the inspection process and verifies inspection logs and findings.
4. Accountability
The Head – Manufacturing is accountable for implementation and effectiveness of this SOP.
5. Procedure
5.1 Inspection Environment
- Perform visual inspection in a well-lit and dust-free area with white and black backgrounds for contrast.
- Ensure availability of required items such as gloves, lint-free wipes, inspection trays, marker pens, and rejection bins.
5.2 Inspection Criteria
- Inspect containers for the following:
- Physical damage (dents, cracks, deformed caps, or tubes)
- Proper sealing and closure integrity
- Correct label placement and legibility
- No particulate matter or foreign contamination on or inside container
- Presence of required batch number, expiry date, and other regulatory markings
5.3 Inspection Process
- Place containers on the inspection tray and rotate 360° for comprehensive check.
- Inspect not less than 100% of units before final packing.
- Segregate any defective units and mark them appropriately with “Rejected”.
- Record findings in the Visual Inspection Log – Annexure-1.
5.4 Handling of Rejected Units
- Rejected containers must be collected separately and logged with reasons.
- Inform QA for review and advice on disposition (re-inspection or destruction).
- Rejected units to be destroyed as per SOP on Disposal of Non-Conforming Goods.
5.5 Documentation and Review
- Maintain records of inspection in batch packing records.
- Production Supervisor must verify and sign the log for completeness.
- QA to cross-check entries before batch release.
6. Abbreviations
- QA: Quality Assurance
- SOP: Standard Operating Procedure
7. Documents
- Visual Inspection Log – Annexure-1
- Batch Packing Record
- Rejection Summary Log
8. References
- WHO TRS 986 Annex 2: GMP for Pharmaceutical Products
- 21 CFR Part 211 – Subpart E: Control of Components and Drug Product Containers
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Jr. Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: Visual Inspection Log
| Date | Batch No. | No. of Containers Inspected | Rejected | Rejection Reason | Inspector Initials |
|---|---|---|---|---|---|
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 10/04/2022 | 1.0 | Initial Issue | New SOP | QA Head |
| 09/06/2025 | 2.0 | Added detailed rejection criteria and inspection form | Annual Review | QA Head |