Standard Operating Procedure for Visual Inspection of Gel-Filled Tubes in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/139/2025 |
| Supersedes | SOP/GM/139/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To establish a standard procedure for visual inspection of gel-filled tubes to ensure that the final product is free from defects and meets required quality standards.
2. Scope
This procedure applies to all batches of gel-filled tubes manufactured in the gel manufacturing department,
including those undergoing manual or automated inspection prior to packing and release.
3. Responsibilities
- Inspection Operator: Conducts visual inspection as per defined parameters.
- QA Executive: Verifies inspection activity, sampling, and rejects handling.
- Production Supervisor: Ensures trained personnel are deployed and inspection is documented properly.
4. Accountability
Head – Manufacturing
5. Procedure
5.1 Preparation Before Inspection
- Ensure the inspection area is clean and well-illuminated as per 1000 Lux minimum requirement.
- Confirm line clearance and availability of required documents, labels, and rejection containers.
- Verify cleanliness and calibration of inspection table (Annexure-2: Visual Inspection Checklist).
5.2 Inspection Criteria
Inspect each gel tube for the following parameters:
- Tube integrity: no dents, punctures, or leaks
- Sealing: no open or uneven seals
- Labeling: correct label placement, legibility, and batch details
- Product fill: consistent and as per standard weight range
- Appearance: no discoloration, phase separation, or foreign matter
5.3 Visual Inspection Method
- Inspect tubes under standard light, rotating gently for full surface check.
- Rejected tubes must be collected in a labeled ‘Rejected’ bin.
- Rejects must be segregated into categories: labeling issues, fill error, seal defect, physical damage.
- Document total inspected units and rejected units in Visual Inspection Record (Annexure-1).
5.4 Frequency and Sampling
- 100% inspection is required unless validated AQL sampling plan is approved.
- Sampling may be done post-primary inspection to confirm process performance.
5.5 Handling of Defects
- Rejected units should not be returned to the production line without QA disposition.
- Major defects should trigger batch review and QA investigation.
- Minor cosmetic defects may be reworked if allowed by SOP and product requirements.
6. Abbreviations
- QA: Quality Assurance
- AQL: Acceptable Quality Limit
- SOP: Standard Operating Procedure
7. Documents
- Visual Inspection Record – Annexure-1
- Visual Inspection Checklist – Annexure-2
- Batch Manufacturing Record (BMR)
8. References
- WHO GMP Guidelines for Visual Inspection
- Schedule M: Good Manufacturing Practices for Pharmaceuticals
- Internal Quality Manual
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 Record
| Date | Batch No. | Total Inspected | Total Rejected | Defect Type | Operator | Remarks |
|---|---|---|---|---|---|---|
Annexure-2: Visual Inspection Checklist
| Inspection Area | Criteria | Status (Y/N) | Remarks |
|---|---|---|---|
| Lighting | 1000 Lux Min | ||
| Table Cleanliness | No Dust, Debris | ||
| Rejected Bin | Present and Labeled |
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 15/02/2022 | 1.0 | Initial Issue | New SOP | QA Head |
| 09/06/2025 | 2.0 | Updated inspection steps and defect classification | Annual Review | QA Head |