all applicable local, regional, and international regulations.

4. Accountability

The Manufacturing Manager is accountable for ensuring that aerosol cans are properly packed into secondary packaging materials in accordance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparation of Secondary Packaging Materials

1. The packing team must ensure that the appropriate secondary packaging materials (e.g., cartons, shrink wraps, display packs) are available and meet the necessary specifications for product protection and labeling.
2. All secondary packaging materials should be inspected for any damage before use. Any damaged or defective packaging should be rejected and replaced with new materials.
3. Labels should be checked to ensure that they match the product and that they contain all necessary product information, such as batch number, manufacturing date, and expiration date.

5.2. Packing Process

1. The packing team will pack aerosol cans into secondary packaging materials according to the approved packing instructions. The packing process includes:
   • Placing aerosol cans into the correct configuration (e.g., rows and layers) to ensure that the cans are securely packed and protected during transit.
   • Ensuring that no cans are damaged during the packing process.
   • Verifying that the correct number of cans is packed into each secondary packaging unit, as specified in the packing instructions.
   • Securing the packs with sealing tape, shrink wrap, or other appropriate materials to ensure that the products are secure and tamper-evident.
2. If any defects or issues are found during the packing process, the affected products should be segregated, and the issue should be documented in the Packing Defect Log (Annexure-1).

5.3. Labeling and Inspection

1. After packing, each secondary package (carton, shrink-wrapped bundle, etc.) should be inspected to ensure that the correct labels are applied, including:
   • Product name
   • Batch number
   • Expiration date
   • Other regulatory information (e.g., safety warnings, manufacturer’s details)
2. The QA team will verify that the labeling is correct and that the labels are securely attached to the packaging. Any discrepancies should be reported and corrected before further processing.
3. All inspection results should be documented in the Labeling and Inspection Log (Annexure-2).

5.4. Final Approval for Packing

1. Once the packing process is complete and the products have been inspected for labeling accuracy and packaging integrity, the QA team will conduct a final inspection to approve the packed products for release.
2. The QA team will verify that the batch records are complete and that all required checks and inspections have been performed. If the packed products pass the inspection, they will be approved for further distribution.
3. Any deviations or non-conformances should be documented in the Deviation Log (Annexure-3) and addressed promptly before product release.

5.5. Documentation and Record Keeping

1. All packing activities, including packing defects, inspection results, and any deviations, must be documented to ensure traceability and compliance. Relevant documentation should include:
   • Packing Defect Log (Annexure-1)
   • Labeling and Inspection Log (Annexure-2)
   • Deviation Log (Annexure-3)
2. Records should be retained for a minimum of 3 years or as required by regulatory guidelines. All records must be signed and dated by the personnel involved in the packing process.

5.6. Reporting and Compliance

1. If any regulatory issues are identified during the packing process, they should be reported to the Regulatory Affairs Team immediately. The Regulatory Affairs Team will ensure that any necessary corrective actions are taken and that appropriate notifications are made to regulatory authorities.
2. The QA team will review the packing process 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. Packing Defect Log (Annexure-1)
2. Labeling and Inspection Log (Annexure-2)
3. Deviation 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: Packing Defect Log

Defect ID	Defect Description	Action Taken	Operator Name	Approval
DEF-001	Misaligned shrink wrap	Repacked affected cans	Rajesh Patel	Approved

Annexure-2: Labeling and Inspection Log

Batch Number	Inspection Date	Inspector Name	Comments
Batch-001	10/02/2025	Rajesh Patel	Labels applied correctly, no issues

Annexure-3: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Responsible Person	Status
DEV-12345	Packaging material defect	Replaced defective materials	Rajesh Patel	Completed

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 packing process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures