in inspecting finished gel units (tubes, jars, sachets) post primary and secondary packaging, at the pharmaceutical manufacturing facility.

3. Responsibilities

• Packaging Operator: Present packed units for inspection in appropriate trays.
• Inspector: Conduct systematic visual checks as per defined checklist.
• QA Officer: Monitor adherence to inspection procedures and maintain documentation.
• Packaging Supervisor: Ensure rejected units are segregated and reported.

4. Accountability

The Head – Manufacturing is accountable for compliance of the visual inspection activity and documentation of packed gel units.

5. Procedure

5.1 Pre-Inspection Requirements

1. Ensure sufficient lighting (minimum 1000 lux) at the inspection table or conveyor area.
2. Calibrate and clean magnifying lenses or visual aids if used.
3. Prepare the Visual Inspection Checklist (Annexure-1).
4. Verify batch number, quantity, and packaging specifications from the batch record.

5.2 Visual Inspection Steps

1. Take packed gel units in trays containing a defined number of units (e.g., 100 per tray).
2. Visually inspect each unit for the following parameters:
   • Sealing integrity (no leakage or improper crimping)
   • Label placement and orientation
   • Print legibility (batch number, manufacturing date, expiry date)
   • Presence of foreign particles inside transparent tubes (if applicable)
   • Damage to tubes, dents, or discoloration
3. Segregate rejected units in a labeled “REJECTED” bin for rework or destruction.
4. Document inspection results in the Visual Inspection Logbook (Annexure-2).

5.3 Frequency and Acceptance Criteria

1. Conduct 100% visual inspection for market-release batches.
2. In case of contract manufacturing, follow the customer-defined sampling plan if specified.
3. Reject any unit not conforming to defined acceptance parameters.

5.4 Post-Inspection

1. Count and reconcile the accepted vs. rejected quantity.
2. Report anomalies or repeated defects to the QA team immediately.
3. Affix inspection status labels (e.g., “VISUALLY CHECKED”) on completed trays.
4. Forward passed units for secondary packaging or batch release.

6. Abbreviations

• QA: Quality Assurance
• SOP: Standard Operating Procedure
• BMR: Batch Manufacturing Record

7. Documents

1. Visual Inspection Checklist – Annexure-1
2. Visual Inspection Logbook – Annexure-2
3. Packaging Batch Record
4. Rejection Report Form

8. References

• Schedule M – Packaging and Labeling
• WHO GMP Guidelines for Visual Inspection
• Internal QA Inspection Procedures

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

Sr. No.	Inspection Parameter	Yes/No	Remarks
1	Tube sealed properly
2	Label alignment and clarity
3	Legible batch and expiry details
4	No visual foreign matter inside
5	No dents/damages on packaging

Annexure-2: Visual Inspection Logbook

Date	Batch No.	Product Name	Units Inspected	Units Rejected	Inspector Name	Remarks

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
02/06/2022	1.0	Initial version	New SOP	QA Head
02/06/2025	2.0	Added checklist and reconciliation section	Annual review	QA Head