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

1. Ensure the inspection area is clean and well-illuminated as per 1000 Lux minimum requirement.
2. Confirm line clearance and availability of required documents, labels, and rejection containers.
3. 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

1. Inspect tubes under standard light, rotating gently for full surface check.
2. Rejected tubes must be collected in a labeled ‘Rejected’ bin.
3. Rejects must be segregated into categories: labeling issues, fill error, seal defect, physical damage.
4. Document total inspected units and rejected units in Visual Inspection Record (Annexure-1).

5.4 Frequency and Sampling

1. 100% inspection is required unless validated AQL sampling plan is approved.
2. Sampling may be done post-primary inspection to confirm process performance.

5.5 Handling of Defects

1. Rejected units should not be returned to the production line without QA disposition.
2. Major defects should trigger batch review and QA investigation.
3. 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

1. Visual Inspection Record – Annexure-1
2. Visual Inspection Checklist – Annexure-2
3. 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