any repairs or modifications are documented and evaluated for impact on system qualification.

Production Team: Responsible for reporting any operational issues related to the compressed air system and ensuring that the system functions properly during production.

Quality Assurance (QA) Team: Responsible for reviewing and approving the compressed air system qualification report to ensure that it complies with GMP and regulatory requirements.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the compressed air system is qualified and maintained according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Compressed Air System Qualification

1. Ensure that the compressed air system is fully installed, operational, and ready for qualification testing. This includes the compressor, air filters, regulators, piping, and any other components involved in the compressed air supply.
2. Verify that all components of the system have been installed according to the manufacturer’s specifications, and that the system is free from any leaks or damage.
3. Review the equipment’s technical specifications to understand the required performance parameters, including air flow rate, pressure, temperature, and cleanliness standards.
4. Ensure that the compressed air system is equipped with appropriate filtration to remove particulates, oils, and other contaminants from the air supply, in line with industry standards.
5. Establish the qualification team, including representatives from Engineering, Production, and QA teams. Ensure that personnel are trained in the qualification process and familiar with the equipment and specifications.

5.2. Performing the Compressed Air System Qualification

1. The qualification process should include the following tests to ensure that the compressed air system meets the required standards:
   • Airflow and Pressure Test: Verify that the air supply meets the required airflow rate and pressure. This should be done under both normal and peak production conditions. Measure the pressure at key points throughout the system and ensure that it is within the acceptable range.
   • Purity and Cleanliness Test: Verify that the compressed air is free from contaminants, including particulates, oils, and moisture. Use appropriate air quality testing methods such as particle counters and moisture detectors to assess air purity. Compare results to regulatory standards for clean air in manufacturing environments (e.g., ISO 8573 standards).
   • Leak Test: Perform a leak test on the compressed air system to ensure that there are no air leaks in the system, which could affect performance or result in contamination. Use ultrasonic leak detection equipment or other methods to identify and correct any leaks.
   • Temperature Test: Verify that the temperature of the compressed air is within the specified range, typically between 15°C and 25°C. Excessive temperatures can affect the quality of the product and the operation of equipment.
   • Backup System Test: Verify that the backup air supply system, if applicable, functions as intended during system downtime or in case of failure of the primary air compressor.
2. Record all test results, including measured values, test conditions, and any deviations from the specified parameters. Document the results in the Compressed Air System Qualification Report (Annexure-1).

5.3. Documenting the Qualification Results

1. Document the following information in the Compressed Air System Qualification Report (Annexure-1):
   • System ID, compressor model, and serial number
   • Test methods and acceptance criteria used during qualification
   • The results of each test performed, including any deviations or non-conformities
   • Corrective actions taken to address any deviations or issues observed during the qualification process
   • The name and signature of the personnel performing the qualification tests
   • Approval signatures from the QA team
2. Ensure that the qualification report is signed by the responsible personnel and reviewed by the QA team for completeness and accuracy.

5.4. Reviewing and Approving the Qualification Report

1. The QA team should review the Compressed Air System Qualification Report to ensure that the system meets all operational and cleanliness requirements and that the system functions as expected under normal and peak conditions.
2. If any deviations are identified during the qualification process, they should be documented in the Deviation Log (Annexure-2), and corrective actions should be taken.
3. The QA team should approve the report once all qualification activities are complete and any deviations have been addressed.

5.5. Finalizing the Qualification Process

1. Once the system has been successfully qualified, it is considered ready for use in the aerosol manufacturing process. The system can now be used for production without restriction.
2. All documentation, including the Compressed Air System Qualification Report, Deviation Log, and any corrective actions, should be archived for future audits and inspections.
3. Periodic requalification of the compressed air system should be scheduled as needed to ensure continued compliance with regulatory requirements and system performance standards.

6. Abbreviations

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

7. Documents

1. Compressed Air System Qualification Report (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action 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 8573 – Compressed Air Quality Standards

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Compressed Air System Qualification Report

System ID	Compressor Model	Serial Number	Test Date	Test Type	Result
CA-001	Model X	SN123456	06/02/2025	Airflow and Pressure Test	Pass
CA-001	Model X	SN123456	06/02/2025	Purity Test	Pass

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Pressure drop in system	Replaced pressure regulator	Rajesh Patel	Completed

Annexure-3: Corrective Action Log

Action ID	Action Description	Responsible Person	Completion Date
CA-12345	Replaced air filter	Rajesh Patel	06/02/2025

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