used to seal or apply packaging materials is properly maintained and calibrated.

4. Accountability

The Manufacturing Manager is accountable for ensuring that packaging materials are inspected for integrity and quality before use. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Inspection of Packaging Materials

1. All packaging materials should be inspected upon receipt from suppliers and before use in the packing process. The inspection process should include:
   • Visual inspection of packaging materials for defects such as tears, holes, dents, or contamination.
   • Checking the integrity of seals and closures on packaging materials to ensure they will function correctly during packing and storage.
   • Verifying that the material is of the correct type and specification (e.g., the correct size and type of cans, valves, actuators, cartons, etc.).
   • Ensuring that packaging materials are stored in a clean, dry environment to prevent contamination.
2. The warehouse team should store packaging materials in a designated area, ensuring that they are protected from environmental factors such as moisture, temperature fluctuations, and contamination.
3. If any defects or issues are identified with packaging materials, they should be rejected and reported to the QA team for further investigation. A record of the inspection should be maintained in the Packaging Material Inspection Log (Annexure-1).

5.2. Packaging Material Acceptance Criteria

1. The following criteria should be used to accept packaging materials:
   • All materials must be free from any visible defects such as cracks, dents, or contamination.
   • Packaging materials should meet the product’s specified dimensions, weight, and other technical specifications.
   • Labels on secondary packaging materials should be applied correctly, free from smudges, and legible.
2. If any packaging materials do not meet the acceptance criteria, they should be removed from the production area and segregated for investigation. The issue should be documented in the Packaging Material Non-Conformance Log (Annexure-2).

5.3. Supplier Quality Assurance

1. All packaging material suppliers must be qualified, and the materials must meet established quality standards before use. The QA team will verify that the suppliers have been properly qualified and that the materials provided meet the necessary specifications.
2. The QA team will review any supplier certifications or batch certifications for packaging materials, ensuring that the materials are compliant with regulatory requirements.
3. Any concerns with packaging material quality or integrity should be raised with the supplier, and the supplier should provide corrective actions if necessary. These issues should be documented in the Supplier Quality Assurance Log (Annexure-3).

5.4. Packaging Material Storage

1. Packaging materials should be stored in a clean, dry, and safe environment to prevent contamination or damage. The storage area should be regularly monitored to ensure that the materials are stored properly.
2. All packaging materials should be rotated using the FIFO (First In, First Out) method to ensure that older materials are used before newer ones.
3. During storage, packaging materials should be kept off the floor to avoid contamination from dust, dirt, or other contaminants. They should be protected from direct sunlight, moisture, or extreme temperatures.

5.5. Documentation and Record Keeping

1. All activities related to packaging material inspections, acceptance, and storage must be documented to ensure traceability and compliance. Documentation should include:
   • Packaging Material Inspection Log (Annexure-1)
   • Packaging Material Non-Conformance Log (Annexure-2)
   • Supplier Quality Assurance Log (Annexure-3)
2. All records should be signed and dated by the personnel involved in the inspection and approval process. These records should be stored in the document management system for future reference and audits.
3. Packaging material records must be retained for a minimum of 3 years or as required by regulatory guidelines.

5.6. Reporting and Compliance

1. If any packaging material issues are identified, they should be reported to the QA team immediately. The QA team will investigate and ensure that corrective actions are taken as needed.
2. The QA team will periodically review the packaging material integrity procedures during internal audits to ensure ongoing compliance with GMP and regulatory standards.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure
• QA: Quality Assurance

7. Documents

1. Packaging Material Inspection Log (Annexure-1)
2. Packaging Material Non-Conformance Log (Annexure-2)
3. Supplier Quality Assurance Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Packaging Material Inspection Log

Batch Number	Inspection Date	Material Type	Inspector Name	Comments
Batch-001	10/02/2025	Cartons	Rajesh Patel	All cartons in good condition, no visible defects

Annexure-2: Packaging Material Non-Conformance Log

Non-Conformance ID	Non-Conformance Description	Action Taken	Responsible Person	Status
NC-001	Damaged cartons received	Rejected and returned to supplier	Rajesh Patel	Completed

Annexure-3: Supplier Quality Assurance Log

Supplier Name	Material Type	Quality Check Date	Result	Action Taken
Supplier A	Cartons	10/02/2025	Pass	No action required

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated packaging material inspection procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures