is properly maintained, calibrated, and functioning efficiently to prevent malfunctions during the filling process.

Health and Safety Officer: Ensures that the filling process is carried out safely, including the proper handling of liquid components and propellants, and the use of appropriate safety equipment.

4. Accountability

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

5. Procedure

5.1. Preparation for the Filling Process

1. Ensure that all necessary materials and equipment are available and properly prepared for the filling process. This includes:
   • Empty aerosol cans
   • Liquid components to be filled (active ingredients, excipients, and propellants)
   • Filling equipment (e.g., automated filling machines, valves, crimping tools)
   • Personal protective equipment (PPE) for operators
2. Inspect all aerosol cans for defects, such as dents, cracks, or leaks. Reject any damaged cans to prevent potential product defects.
3. Ensure that the liquid components are properly mixed and homogeneous before the filling process begins. If applicable, verify that the formulation has been pre-heated to the required temperature.

5.2. Filling the Aerosol Cans

1. Load the empty aerosol cans into the filling machine, ensuring they are correctly aligned and securely held in place.
2. Activate the filling machine to start the process. The machine will automatically fill the cans with the appropriate amount of liquid formulation. Ensure that the correct volume of the liquid is filled into each can, based on the formulation specifications.
3. Monitor the filling machine during the process to ensure that the proper quantity is dispensed into each can. Check that there are no inconsistencies in the volume or spillage of the formulation.
4. For propellant-based products, ensure that the appropriate amount of propellant is injected into the cans after the liquid filling process. The filling machine should accurately charge the correct amount of propellant.

5.3. In-Process Checks

1. Perform in-process checks to verify the accuracy and consistency of the filling process. Common checks include:
   • Visual inspection of the filled volume
   • Weighing the filled cans to verify the correct amount of liquid
   • Measuring the can weight against the target weight
   • Ensuring that the valve and actuator are securely fitted after filling
2. If any cans are found to be underfilled or overfilled, immediately halt the process and adjust the filling machine settings accordingly. Document any deviations in the Filling Deviation Log (Annexure-1).

5.4. Post-Filling Procedure

1. After the liquid is filled into the cans, verify that the cans are sealed properly with the valve and actuator. Ensure that the valve is crimped tightly to prevent any leakage or contamination.
2. Inspect the filled cans for any visible defects, such as leakage, improper sealing, or damage. Reject any defective cans and document the issue in the Defective Product Log (Annexure-2).
3. Transfer the filled and sealed cans to the packaging area for labeling and final quality checks.

5.5. Safety and Environmental Considerations

1. Ensure that the filling process is carried out in a well-ventilated area to prevent the accumulation of propellant vapors and ensure operator safety.
2. All operators must wear appropriate PPE, including gloves, safety goggles, and lab coats, to prevent exposure to hazardous materials.
3. Ensure that all propellant handling and filling activities are carried out in compliance with the company’s safety protocols to avoid spills, leaks, or accidents.
4. Store filled cans in a safe, stable environment to prevent damage or leakage before they are packaged or shipped.

5.6. Documentation and Record-Keeping

1. Document the details of the filling process in the Filling Log (Annexure-3), including:
   • Batch number
   • Operator name and signature
   • Volume filled per can
   • Any deviations or corrective actions taken during the process
2. Ensure that all in-process checks, such as weight verification and visual inspections, are recorded in the In-Process Testing Log (Annexure-4).
3. Store all batch records and logs in compliance with the company’s document retention policy and ensure they are available for review during 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. Filling Log (Annexure-3)
2. In-Process Testing Log (Annexure-4)
3. Filling Deviation Log (Annexure-1)
4. Defective Product 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
• 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: Filling Deviation Log

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

Annexure-2: Defective Product Log

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

Annexure-3: Filling Log

Batch No.	Volume Filled	Operator Name	Date
12345	200ml	Rajesh Patel	06/02/2025

Annexure-4: In-Process Testing Log

Test Parameter	Test Result	Test Date	Tested By
Weight Check	Pass	06/02/2025	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 filling process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures