the crimping machine is in optimal condition prior to performing the PQ and addressing any maintenance issues that arise during the process.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the Performance Qualification of the aerosol crimping machines is carried out in compliance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Performance Qualification

1. Before starting the PQ process, ensure that the aerosol crimping machine has successfully passed the Installation Qualification (IQ) and Operational Qualification (OQ) stages.
2. Ensure that all necessary equipment and materials are available, including aerosol cans, valves, propellants, and sealing materials.
3. Verify that the crimping machine is clean, calibrated, and in good working condition before conducting the PQ process.
4. Ensure that the performance specifications for the crimping machine, as outlined by the manufacturer and internal quality standards, are available for reference during the PQ process.
5. Establish the PQ team, which should include representatives from Engineering, Production, and QA teams.

5.2. Conducting the Performance Qualification

1. Perform the following tests as part of the PQ process:
   • Crimping Consistency: Verify that the crimping machine produces consistent and reliable crimp seals across multiple batches. The test should involve crimping a set number of cans (at least 20) and measuring the consistency of the seal strength and appearance.
   • Sealing Quality: Test the quality of the crimp seal by performing a leak test, ensuring that the crimp is intact and airtight. This test should be performed on several cans, using appropriate methods such as submersion in water or pressure decay tests.
   • Cycle Time: Measure the time required for the crimping machine to complete one cycle, including the time taken to position the aerosol cans, apply the crimp, and remove the finished cans. The cycle time should be within the specified limits for production speed.
   • Machine Performance Under Normal Operating Conditions: Run the crimping machine under normal production conditions for a set period (e.g., 4 hours) to assess the machine’s ability to perform without issues or failures. Monitor for any mechanical failures, downtime, or irregularities in performance.
2. During testing, ensure that all relevant machine settings (e.g., pressure, speed, temperature) are within the specified operating range and meet the manufacturer’s recommendations.
3. Record all test results, including the number of successful crimping cycles, any deviations or failures, and the corrective actions taken. Document the performance data in the Performance Qualification Report (Annexure-1).

5.3. Documenting the Performance Qualification

1. Document the following information in the Performance Qualification Report (Annexure-1):
   • Details of the crimping machine, including the equipment ID, model, serial number, and location
   • The performance specifications for the crimping machine, as well as the operational parameters tested (e.g., crimping consistency, sealing quality, cycle time)
   • The results of each test, including the number of successful tests, any deviations or failures, and the corrective actions taken
   • Signatures of the personnel performing the tests, along with the date and time of testing
2. The Performance Qualification Report should be signed by the responsible team members and reviewed by the QA team.

5.4. Reviewing and Approving the Performance Qualification

1. The QA team should review the Performance Qualification Report to ensure that the crimping machine meets the required performance specifications and is capable of reliably producing quality aerosol products.
2. If any deviations are observed during the PQ process, they should be documented in the Deviation Log (Annexure-2). Corrective actions should be taken, and the tests should be repeated to verify the effectiveness of the corrective actions.
3. The QA team should approve the report once all tests are complete and any deviations have been addressed.

5.5. Finalizing the PQ Process

1. Once the Performance Qualification is completed and approved, the crimping machine can be used for regular production.
2. All documentation, including the Performance Qualification Report and any supporting documents (e.g., deviation reports, corrective actions), should be archived and accessible for future audits and reviews.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• PQ: Performance Qualification

7. Documents

1. Performance Qualification Report (Annexure-1)
2. Deviation Log (Annexure-2)

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
• International Council for Harmonisation (ICH) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Performance Qualification Report

Equipment ID	Model Number	Serial Number	Test Date	Test Type	Result
CRIMP-001	Model X	SN123456	06/02/2025	Crimping Consistency	Pass
CRIMP-001	Model X	SN123456	06/02/2025	Sealing Quality	Pass

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Crimping accuracy out of tolerance	Adjusted crimp pressure	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 performance testing procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures