and approving the cans for packing.

Maintenance Team: Ensures that the leak testing equipment is calibrated, maintained, and functioning properly to guarantee accurate results.

4. Accountability

The Manufacturing Manager is accountable for ensuring that all aerosol cans undergo a proper final leak test before packing. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparation for Leak Testing

1. The Leak Test Team will prepare the aerosol cans for testing by ensuring that all cans have been sealed and are ready for the final leak test.
2. The cans should be visually inspected to ensure there are no obvious defects such as dents, cracks, or improper sealing before they undergo the leak test.
3. All leak testing equipment must be calibrated and inspected according to the equipment calibration schedule. The Leak Testing Equipment Log (Annexure-1) should be checked for the most recent calibration and maintenance records.

5.2. Conducting the Leak Test

1. The Leak Test Team will perform the final leak tests on a sample of aerosol cans. The tests should include:
   • Pressure test: The cans will be subjected to a specified pressure to check for any signs of leakage. This may be done using automated pressure testing machines.
   • Visual inspection: After pressure testing, the cans should be inspected for visible signs of leakage such as gas escaping or deformation.
   • Sound test: If applicable, a sound test may be performed by using an acoustic detector to identify any hissing sound caused by gas escaping from a can.
2. Any cans failing the leak test should be segregated and the failure documented in the Leak Test Failure Log (Annexure-2). The cans should not proceed to the packing stage.
3. If the failure rate exceeds acceptable levels, the testing procedure should be reviewed, and corrective actions should be taken as per the Corrective Action Log (Annexure-3).

5.3. Post-Test Inspection and Documentation

1. After testing, the Leak Test Team will perform a final inspection to ensure that all cans passing the leak test are properly labeled and free from any other defects. Cans passing the test will be approved for packing.
2. All results of the leak test, including passed and failed cans, should be documented in the Leak Test Log (Annexure-4). This log should include details such as batch number, test date, operator name, and any corrective actions taken.
3. The Leak Test Team should ensure that all documents are completed and signed before the cans are moved to the next stage of production.

5.4. Approval for Packing

1. Once the leak test has been completed and the cans have passed the test, the QA team will review the test results and approve the cans for packing. The cans will then be moved to the packaging area for secondary packaging.
2. If any cans fail the leak test, the QA team will ensure that corrective actions are taken before further production continues. The non-compliant cans should be documented in the Deviation Log (Annexure-5).

5.5. Documentation and Record Keeping

1. All leak testing activities must be documented to ensure traceability and compliance. Documentation should include:
   • Leak Test Failure Log (Annexure-2)
   • Leak Test Log (Annexure-4)
   • Deviation Log (Annexure-5)
   • Corrective Action Log (Annexure-3)
2. All records should be signed and dated by the personnel involved in the testing process. The records should be stored in the document management system for future reference and audits.
3. Leak testing records must be retained for a minimum of 3 years or as required by regulatory guidelines.

5.6. Reporting and Compliance

1. If any issues or non-compliances are identified during the leak test, the Leak Test Team must report them to the QA Manager immediately. The QA team will ensure that the issue is investigated, and corrective actions are implemented if necessary.
2. The QA team will review the leak testing 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. Leak Testing Equipment Log (Annexure-1)
2. Leak Test Failure Log (Annexure-2)
3. Corrective Action Log (Annexure-3)
4. Leak Test Log (Annexure-4)
5. Deviation Log (Annexure-5)

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: Leak Testing Equipment Log

Equipment ID	Calibration Date	Maintenance Date	Operator Name	Remarks
LE-001	05/02/2025	04/02/2025	Rajesh Patel	Calibrated and ready for use

Annexure-2: Leak Test Failure Log

Batch Number	Test Type	Test Result	Action Taken	Responsible Person
Batch-001	Pressure test	Fail	Replaced defective cans	Rajesh Patel

Annexure-3: Corrective Action Log

Deviation ID	Corrective Action	Implementation Date	Responsible Person	Outcome
DEV-12345	Re-calibrated leak testing equipment	07/02/2025	Rajesh Patel	Completed, verified

Annexure-4: Leak Test Log

Batch Number	Test Date	Test Type	Result	Operator Name
Batch-001	10/02/2025	Pressure test	Pass	Rajesh Patel

Annexure-5: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Responsible Person	Status
DEV-12345	Leaky valve	Replaced valve on affected cans	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 leak testing procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures