to the visual inspection of all primary and secondary packaging materials received and stored for use in the sterile injectable manufacturing unit.

3. Responsibilities

• Warehouse Personnel: To conduct initial visual checks upon material receipt.
• IPQA Officer: To verify and document findings of visual inspection.
• QC Inspector: To evaluate suspect lots or any observed nonconformance.

4. Accountability

The Head of Quality Assurance is accountable for compliance with this SOP and implementation of corrective actions for any identified deviations.

5. Procedure

5.1 Preparation

1. Ensure cleanliness of the inspection area and availability of adequate lighting.
2. Retrieve packaging materials from quarantine/storage area as per the dispatch note or requisition.
3. Use the Packaging Material Visual Inspection Checklist (Annexure-1) during the process.

5.2 Inspection Criteria

1. Vials: Check for cracks, scratches, embedded particles, discoloration, irregular shapes, or foreign matter.
2. Rubber Stoppers: Inspect for surface defects, color inconsistencies, embedded particles, or deformities.
3. Flip-off Seals: Ensure print legibility, proper color coding, and freedom from dents or missing parts.
4. Labels & Leaflets: Check for misprints, blurring, missing information, wrong artwork, and batch placeholders.
5. Cartons & Shippers: Inspect for physical damage, wetness, incorrect printing, and layout mismatches.

5.3 Acceptance and Rejection

1. Segregate the inspected lot into “Accepted” and “Rejected” areas clearly marked within the inspection zone.
2. Fill the Packaging Material Inspection Record (Annexure-2) for each inspected lot.
3. Rejected material shall be labeled as “Rejected – Hold for Disposition” and sent to QC for further evaluation.
4. Accepted lots shall be labeled “Approved” and transferred to approved storage locations.

5.4 Handling of Non-Conformance

1. Initiate a Non-Conformance Report (NCR) (Annexure-3) for any rejected batch.
2. QC shall evaluate the defect type and decide on reinspection, return, or destruction.
3. Update the Defect Trending Log (Annexure-4) for repeated issues with supplier materials.

6. Abbreviations

• SOP: Standard Operating Procedure
• IPQA: In-Process Quality Assurance
• QC: Quality Control
• NCR: Non-Conformance Report

7. Documents

1. Packaging Material Visual Inspection Checklist – Annexure-1
2. Packaging Material Inspection Record – Annexure-2
3. Non-Conformance Report – Annexure-3
4. Defect Trending Log – Annexure-4

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO GMP Guidelines for Pharmaceuticals
• ISPE Baseline Guide Vol. 6 – Packaging

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Packaging Material Visual Inspection Checklist

Material Type	Checked For	Acceptable (Y/N)	Remarks
Rubber Stopper	Surface Cleanliness	Y	OK

Annexure-2: Packaging Material Inspection Record

Material	Supplier	Batch No.	Status	Inspected By
Glass Vials	Indian Pharma Glass	G1234	Approved	Sunita Reddy

Annexure-3: Non-Conformance Report (NCR)

Material	Defect Observed	Disposition	QC Decision
Flip-off Seal	Print Missing	Return to Supplier	Approved

Annexure-4: Defect Trending Log

Supplier	Material	Defect Type	Occurrences
PharmaSeal Ltd.	Seals	Print Smudging	3

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
05/03/2022	1.0	Initial version	New SOP	QA Head
18/06/2025	2.0	Updated visual criteria, added trending log	Annual review	QA Head