Standard Operating Procedure for Visual Inspection of Filled Gel Tubes in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/116/2025 |
| Supersedes | SOP/GM/116/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 02/06/2025 |
| Effective Date | 04/06/2025 |
| Review Date | 02/06/2027 |
1. Purpose
To lay down the procedure for performing visual inspection of filled gel tubes for identifying any cosmetic or critical defects prior to secondary packaging.
2. Scope
This procedure applies to all batches of gel formulations filled in collapsible or laminated tubes in the gel
manufacturing department.
3. Responsibilities
- Production Operator: Conducts visual inspection as per training and defect identification criteria.
- Production Supervisor: Ensures process adherence and documents inspection records.
- QA Inspector: Performs periodic verification and line clearance post-inspection.
4. Accountability
Head – Manufacturing
5. Procedure
5.1 Preparation for Visual Inspection
- Inspectors must be trained in defect identification and visual acuity testing must be valid.
- Set up visual inspection booth with uniform white lighting (~1000 Lux) and black/white background.
- Ensure cleanliness of inspection area, bench, gloves, and collection trays.
5.2 Defect Categories
Defects are classified as follows:
- Critical: Broken seal, leakage, contamination, improper closure.
- Major: Improper labeling, dented/crushed tube, offset printing.
- Minor: Smudging, slight variation in crimp, cosmetic scuff marks.
5.3 Execution of Visual Inspection
- Collect filled tubes post-crimping and organize in inspection trays.
- Inspect each tube against white and black backgrounds under light.
- Rotate tubes to observe 360° surface and crimp integrity.
- Segregate defective tubes into designated rejection bins based on defect type.
- Record number of inspected and rejected units in the inspection logbook.
5.4 Reconciliation and Review
- After inspection, reconcile the number of accepted and rejected units.
- Generate summary report showing defect trends and batch defect rate.
- Submit report to QA for batch record compilation.
6. Abbreviations
- QA: Quality Assurance
- Lux: Unit of illumination
- SOP: Standard Operating Procedure
7. Documents
- Visual Inspection Checklist – Annexure-1
- Defect Reference Chart – Annexure-2
- Inspection Logbook – Annexure-3
8. References
- WHO TRS 961 Annex 3: GMP for Pharmaceutical Products
- FDA Guidance on Visual Inspection of Drug Products
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 Checklist
| Parameter | Yes/No | Remarks |
|---|---|---|
| Seal Intact | ||
| Proper Label | ||
| Tube Body Free from Defect | ||
| Batch Code & Mfg. Date Present |
Annexure-2: Defect Reference Chart
| Defect Type | Image Reference | Category |
|---|---|---|
| Cracked Cap | DRC-01 | Critical |
| Printing Misalignment | DRC-02 | Major |
| Scuff Marks | DRC-03 | Minor |
Annexure-3: Inspection Logbook Format
| Date | Batch No. | No. of Tubes Inspected | No. of Defects | Remarks | Inspector |
|---|---|---|---|---|---|
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 28/08/2022 | 1.0 | Initial SOP | New SOP | QA Head |
| 02/06/2025 | 2.0 | Updated inspection parameters and annexures | Annual Review | QA Head |