SOP for QA Verification of Packed Products

Department	Aerosol
SOP No.	SOP/Aerosol/099/2025
Supersedes	SOP/Aerosol/099/2022
Page No.	Page 1 of Y
Issue Date	06/02/2025
Effective Date	16/02/2025
Review Date	06/02/2028

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for Quality Assurance (QA) verification of packed aerosol products to ensure that they meet the required specifications and comply with regulatory standards. The objective is to ensure that the final packed products are properly labeled, sealed, and packaged before they are released for distribution.

2. Scope

This SOP applies to all aerosol products packed at [Company Name]. It covers the QA verification process after packing to ensure that the packed products comply with all quality standards, labeling regulations, and packaging specifications.

3. Responsibilities

• Production Team: Responsible for ensuring that aerosol products are packed according to specified instructions and that any issues are promptly reported to the QA team.
• Quality Assurance (QA) Team: Responsible for verifying the quality of packed products, inspecting for defects, ensuring regulatory compliance, and approving or rejecting products for release.
• Packing Team: Responsible for executing the packing process, ensuring that all aerosol cans are correctly labeled, sealed, and packaged according to the specifications.
• Warehouse Team: Responsible for storing and managing finished goods, ensuring that products awaiting verification are properly handled.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the packed products are properly verified by the QA team before being released for distribution. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Initial Inspection of Packed Products

1. The QA team will perform an initial inspection of a random sample of packed aerosol products. The inspection should include:
   • Visual inspection of the packaging to ensure there are no defects such as damaged cartons, cans, or seals.
   • Verification that the correct labeling is applied and legible on all products.
   • Ensuring that the labels contain all necessary information, including batch number, manufacturing date, expiration date, and regulatory compliance information (e.g., warnings and certifications).
2. If any defects or discrepancies are identified, the affected products should be segregated and documented in the Packaging Defect Log (Annexure-1). These products should not proceed to the warehouse until corrective actions have been taken.

5.2. Seal Integrity Check

1. The QA team will perform a seal integrity check on the packed aerosol cans to ensure that they are properly sealed and free from leaks. The checks should include:
   • Visual inspection of the crimping or sealing of aerosol cans.
   • Leak detection using appropriate testing methods (e.g., pressure test, leak detectors).
2. Any cans failing the seal integrity test should be segregated for re-sealing or disposal. This failure should be documented in the Seal Integrity Failure Log (Annexure-2).

5.3. Label Verification

1. Each batch of packed aerosol products will be inspected by the QA team to ensure that the labels are applied correctly and are free from errors. This should include:
   • Checking the alignment and attachment of labels on each can.
   • Verifying that the correct batch number, manufacturing date, and expiration date are present.
   • Ensuring that regulatory information, such as warnings and ingredients, is clearly stated.
2. Any issues found with labeling should be documented in the Labeling Error Log (Annexure-3), and the affected products should be removed from the packaging line for re-labeling.

5.4. Compliance with Packaging Specifications

1. The QA team will verify that all packing materials used meet the specified requirements, including:
   • Correct type of cartons, shrink wraps, or secondary packaging used for the products.
   • Proper sealing and security of the packaging.
   • Correct placement and orientation of aerosol cans within the packaging.
2. Any non-conformance found during packaging verification should be documented in the Packaging Non-Conformance Log (Annexure-4) and corrective action should be taken.

5.5. Final Approval for Release

1. After completing the inspections and ensuring that the packed aerosol products meet all specifications, the QA team will approve the batch for release. The batch approval will be documented in the Final Release Log (Annexure-5).
2. If any issues are identified during the final inspection, the QA team will document the non-conformance in the Deviation Log (Annexure-6) and take corrective actions as required.

5.6. Documentation and Record Keeping

1. All QA verification activities should be documented, including the inspection results, any issues identified, and corrective actions taken. The following logs should be maintained:
   • Packaging Defect Log (Annexure-1)
   • Seal Integrity Failure Log (Annexure-2)
   • Labeling Error Log (Annexure-3)
   • Packaging Non-Conformance Log (Annexure-4)
   • Final Release Log (Annexure-5)
   • Deviation Log (Annexure-6)
2. All records should be signed and dated by the personnel involved in the verification process. These records should be stored in the document management system for future reference and regulatory audits.
3. QA verification records should be retained for a minimum of 3 years or as required by regulatory guidelines.

5.7. Reporting and Compliance

1. If any non-compliance is identified during the verification process, the QA team must ensure that corrective actions are implemented and that the issue is resolved before the products are released for distribution.
2. The QA team will review the QA verification 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. Packaging Defect Log (Annexure-1)
2. Seal Integrity Failure Log (Annexure-2)
3. Labeling Error Log (Annexure-3)
4. Packaging Non-Conformance Log (Annexure-4)
5. Final Release Log (Annexure-5)
6. Deviation Log (Annexure-6)

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 Defect Log

Batch Number	Defect You said: C ChatGPT said: Here is the continuation of SOP for Topic 99: SOP for QA Verification of Packed Products: html Copy Edit	Defect Description	Action Taken	Operator Name	Approval
Batch-001	Damaged carton	Rejected and replaced	Rajesh Patel	Approved

Annexure-2: Seal Integrity Failure Log

Batch Number	Failure Description	Action Taken	Operator Name	Approval
Batch-001	Loose seal detected	Re-sealed affected cans	Rajesh Patel	Approved

Annexure-3: Labeling Error Log

Batch Number	Error Type	Action Taken	Operator Name	Approval
Batch-001	Incorrect label applied	Re-labeled affected cans	Rajesh Patel	Approved

Annexure-4: Packaging Non-Conformance Log

Batch Number	Non-Conformance Description	Action Taken	Responsible Person	Status
Batch-001	Incorrect packaging material	Replaced packaging material	Rajesh Patel	Completed

Annexure-5: Final Release Log

Batch Number	Approval Date	Approving Authority	Comments
Batch-001	10/02/2025	Anjali Sharma	Approved for distribution

Annexure-6: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Responsible Person	Status
DEV-12345	Incorrect labeling detected	Re-labeled affected products	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 QA verification process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures