and prefilled syringes) post-secondary packaging stage and before storage or dispatch in the Packaging Department.

3. Responsibilities

• Packaging Operators: Conduct visual inspection as per training and guidelines.
• Packaging Supervisors: Monitor compliance and complete inspection documentation.
• QA Officers: Verify inspection results and perform sample rechecks.

4. Accountability

The Head of Packaging is accountable for ensuring that visual inspection is completed and documented for each batch before batch release.

5. Procedure

5.1 Preparation for Inspection

1. Ensure area cleanliness and lighting conditions meet SOP/ENV/114/2024 requirements.
2. Verify that inspectors are qualified and trained for visual inspection tasks.
3. Ensure all products to be inspected are arranged in labeled crates or trays with batch details.

5.2 Visual Inspection Criteria

1. Inspect outer cartons for:
   • Correct batch coding, printing clarity, and label alignment
   • No damage, crushed corners, or soiling
2. Check inner boxes for:
   • Correct leaflet inclusion (if applicable)
   • Seal integrity and tamper-evidence
3. Inspect for:
   • Presence of correct product labeling
   • Uniformity of packing style
   • No misprints or mixed components

5.3 Inspection Methodology

1. Perform 100% visual inspection for critical batches or as per QRM-based sampling plan (Annexure-2).
2. Use the Inspection Log Sheet (Annexure-1) to document inspection results.
3. Flag and segregate defective units in the “Rejected Material Bin.”
4. Defects to look for:
   • Incorrect label, wrong batch number
   • Physical damage or leakage in primary packaging
   • Missing leaflet (if applicable)
   • Illegible or smudged print
5. Instruct QA for re-inspection if rejection rate exceeds control threshold (e.g., 1%).

5.4 Documentation

1. All inspected trays shall be tagged with “Inspected by” slip (signed and dated).
2. Record inspection activity in batch packaging records.
3. Report any deviation to QA using deviation form (SOP/QA/112/2023).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QRM: Quality Risk Management

7. Documents

1. Inspection Log Sheet – Annexure-1
2. Sampling Plan for Visual Inspection – Annexure-2

8. References

• ICH Q9: Quality Risk Management
• WHO TRS 986 Annex 2: GMP for Pharmaceutical Products

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Packaging Officer	QA Executive	Head QA
Department	Packaging	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Inspection Log Sheet

Batch No.	Date	Product	No. of Units Inspected	Defects Found	Inspector Name	Remarks
BN2025A15	24/06/2025	Ceftriaxone 1g	2500	3	Sunita Reddy	OK

Annexure-2: Sampling Plan for Visual Inspection

Batch Size	Sample Size	Acceptance Criteria	Rejection Criteria
Up to 5000	500	≤ 5 Defects	> 5 Defects
5001–10000	800	≤ 8 Defects	> 8 Defects
10001 and above	1250	≤ 10 Defects	> 10 Defects

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	Head QA
24/06/2025	2.0	Updated sampling plan and documentation procedure	GMP alignment	Head QA