monitoring.

Quality Assurance (QA) Team: Responsible for reviewing and approving the qualification process to ensure that the system meets regulatory and GMP requirements, and for ensuring that any deviations are appropriately documented and addressed.

Production Team: Responsible for assisting in the qualification process, ensuring that the propellant supply system operates correctly during manufacturing, and reporting any abnormalities or failures that could impact product quality.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the propellant supply system is qualified in accordance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Propellant Supply System Validation

1. Ensure that the propellant supply system is installed and ready for qualification. This includes verifying that all components, such as storage tanks, transfer lines, valves, regulators, and dispensing equipment, are properly installed and functioning as intended.
2. Review the system’s design specifications, including the expected flow rates, pressure settings, and safety requirements. Ensure that the system meets the required specifications for storing and dispensing propellants.
3. Verify that the system has been maintained according to the manufacturer’s recommendations and internal maintenance schedules. Document any recent repairs, adjustments, or upgrades made to the system.
4. Ensure that all required calibration equipment is available, including flow meters, pressure gauges, and any other instrumentation required for testing the propellant supply system’s performance.
5. Establish the qualification team, which should include representatives from Engineering, Production, and QA teams. Ensure that personnel are trained in propellant supply system qualification procedures and understand the specifications and requirements for the system.

5.2. Performing the Propellant Supply System Validation

1. The validation process should include the following steps to ensure that the system meets the required performance and safety standards:
   • Installation Qualification (IQ): Verify that the propellant supply system is installed correctly and meets the required specifications. This includes confirming that all components are free from defects, properly connected, and in good working condition.
   • Operational Qualification (OQ): Verify that the system operates according to the specified parameters. Perform tests on the flow rate, pressure, and dispensing accuracy of the system to ensure that it meets design specifications.
   • Performance Qualification (PQ): Test the system’s ability to consistently deliver propellant within the required parameters over a series of operational cycles. This should include verification of system performance under normal and peak production conditions, as well as testing the system’s ability to maintain the desired pressure and flow rates during continuous use.
   • Leak Test: Perform a leak test to ensure that there are no leaks in the propellant supply system. This is critical to ensure the safe and efficient transfer of propellant to aerosol containers without loss or contamination of propellant.
   • Contaminant Test: Verify that the system does not introduce contaminants into the propellant. Perform testing to ensure that the transfer lines and dispensing equipment are free from particulate matter, oils, and other contaminants that could affect product quality.
2. Record all test results, including measured values, test conditions, and any deviations observed. Document the results in the Propellant Supply System Validation Report (Annexure-1).

5.3. Documenting the Validation Results

1. Document the following information in the Propellant Supply System Validation Report (Annexure-1):
   • System ID, model number, serial number, and installation location
   • The test methods and equipment used for validation
   • The results of each test performed, including pressure readings, flow rates, leak test results, and any deviations or non-conformities
   • The name and signature of the personnel performing the validation tests
   • Approval signatures from the QA team
2. Ensure that the validation report is signed by the responsible personnel and reviewed by the QA team for completeness and accuracy.

5.4. Reviewing and Approving the Validation Report

1. The QA team should review the Propellant Supply System Validation Report to ensure that the system meets all operational and safety requirements, and that it consistently delivers propellant within the required specifications.
2. If any deviations are identified during the validation process, they should be documented in the Deviation Log (Annexure-2), and corrective actions should be taken. Ensure that all deviations are addressed before approval.
3. The QA team should approve the report once all validation activities are complete and any deviations have been addressed.

5.5. Finalizing the Validation Process

1. Once the system has been successfully validated, it is considered ready for use in the aerosol manufacturing process. The system can now be used for production activities without restriction.
2. All documentation, including the Propellant Supply System Validation Report, Deviation Log, and any corrective actions, should be archived for future audits and inspections.
3. Periodic revalidation of the propellant supply 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. Propellant Supply System Validation 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 9001 – 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: Propellant Supply System Validation Report

System ID	Model Number	Serial Number	Test Date	Test Type	Result
PS-001	Model A	SN123456	06/02/2025	Flow Rate Test	Pass
PS-001	Model A	SN123456	06/02/2025	Leak Test	Pass

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Pressure deviation during flow rate test	Adjusted pressure regulator	Rajesh Patel	Completed

Annexure-3: Corrective Action Log

Action ID	Action Description	Responsible Person	Completion Date
CA-12345	Recalibrated flow meter	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 procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures