for monitoring the quality of the propellant filling process, performing detailed in-process checks, and verifying that the propellant is filled correctly. They will also oversee corrective actions if deviations occur.

Maintenance Team: Responsible for ensuring that all filling equipment is properly maintained, calibrated, and functioning to prevent malfunction during the filling process.

Health and Safety Officer: Ensures that all safety protocols are followed during the propellant filling process, including ensuring proper ventilation and the safe handling of propellant gases.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed during the propellant filling process. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparation for Quality Check

1. Ensure that all materials, equipment, and tools required for the quality checks are available:
   • Filled aerosol cans
   • Propellant gases (according to formulation specifications)
   • Weighing scales, measurement tools, and testing equipment (e.g., pressure gauges, spray pattern testers)
   • Personal protective equipment (PPE) for operators
2. Verify that the filling equipment is calibrated and functioning properly. Ensure that the gas supply, filling machine, and valve crimping systems are operating according to specifications.
3. Confirm that the operator is trained and understands the importance of accurate filling, proper crimping, and the use of safety measures during propellant handling.

5.2. Quality Check During Propellant Filling

1. During the propellant filling process, perform the following quality checks:
   • Weight Check: Measure the weight of a sample of filled aerosol cans to verify that the correct amount of propellant has been added. The weight should meet the product’s specified fill volume.
   • Pressure Check: Measure the internal pressure of the filled cans to ensure it falls within the acceptable range for the formulation and propellant type.
   • Seal Integrity Check: Visually inspect the cans to ensure the valve is securely crimped and there are no signs of leakage around the valve.
   • Spray Pattern and Actuation Check: Check the spray pattern and actuation of a sample of cans to verify that the valve functions correctly and that the aerosol is dispensed properly.
2. Record all test results in the In-Process Testing Log (Annexure-1). If any discrepancies are detected, investigate the root cause and take corrective actions immediately.

5.3. Handling Deviations

1. If any deviation is found during the quality check (e.g., underfilling, overfilling, leakage), stop the filling process and take the following actions:
   • Identify the root cause of the deviation, which could include equipment malfunction, incorrect settings, or improper filling procedures.
   • Adjust the equipment settings (e.g., filling pressure, speed) or re-calibrate the filling machine as needed.
   • Perform additional checks to verify that the issue has been corrected before resuming production.
   • Document the deviation and corrective actions taken in the Filling Deviation Log (Annexure-2).

5.4. Post-Filling Quality Checks

1. Once the propellant has been filled, conduct a final inspection to verify that the cans are sealed properly and that there is no evidence of leakage or misalignment of the valve system.
2. Perform final checks on a sample of filled cans, including weight checks, spray pattern testing, and valve inspection.
3. Document the results of the final quality checks in the Final Quality Check Log (Annexure-3).
4. Approved cans should be transferred to the next stage of production for labeling or packaging. Reject any defective cans and document the issue in the Defective Product Log (Annexure-4).

5.5. Safety and Environmental Considerations

1. Ensure that the propellant filling process is carried out in a well-ventilated area to prevent the accumulation of potentially hazardous fumes.
2. Operators should wear appropriate PPE, including gloves, goggles, and lab coats, to minimize exposure to propellant gases and any other potentially hazardous materials.
3. Ensure that the filling area is free from any potential ignition sources and that all safety protocols are followed to prevent accidents or spills.

5.6. Documentation and Record-Keeping

1. Document all quality checks performed during the propellant filling process in the In-Process Testing Log (Annexure-1), including the weight, pressure, and spray pattern test results.
2. Record any deviations and corrective actions in the Filling Deviation Log (Annexure-2) and the Defective Product Log (Annexure-4).
3. Store all batch records and logs according to the company’s document retention policy, ensuring they are available for future audits or inspections.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• CAPA: Corrective and Preventive Actions
• PPE: Personal Protective Equipment
• R&D: Research and Development

7. Documents

1. In-Process Testing Log (Annexure-1)
2. Filling Deviation Log (Annexure-2)
3. Final Quality Check Log (Annexure-3)
4. Defective Product Log (Annexure-4)

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
• International Pharmacopoeia (Ph. Int.) – Aerosol Delivery

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: In-Process Testing Log

Test Parameter	Test Result	Test Date	Tested By
Weight Check	Pass	06/02/2025	Rajesh Patel

Annexure-2: Filling Deviation Log

Batch No.	Deviation Description	Corrective Action	Operator Name
12345	Overfill detected	Adjusted filling machine settings	Rajesh Patel

Annexure-3: Final Quality Check Log

Batch No.	Test Parameter	Test Result	Operator Name	Comments
12345	Spray Pattern	Pass	Rajesh Patel	No issues

Annexure-4: Defective Product Log

Batch No.	Defect Description	Action Taken	Operator Name
12345	Leakage from valve	Rejected and reprocessed	Rajesh Patel

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 quality check process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures