process, particularly in relation to handling pressurized containers and any associated hazards.

Maintenance Team: Responsible for ensuring that the equipment used for monitoring fill weights, such as weighing scales or automated systems, is calibrated and maintained for accurate results.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the fill weight monitoring procedure is carried out during the aerosol manufacturing process. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Test Preparation

1. Ensure that aerosol containers are properly positioned and secured on the filling line before the start of the filling process.
2. Calibrate all weighing equipment (e.g., scales, automated systems) according to the manufacturer’s specifications and company procedures.
3. Prepare necessary documents and tools, including:
   • Weighing scales or automated weighing systems
   • Calibration weights
   • PPE, including gloves, goggles, and lab coats
4. Verify that the filling machine is set up according to the formulation’s fill weight requirements and that the correct aerosol formulation is loaded into the system.

5.2. Conducting the Fill Weight Monitoring

1. Start the filling process and monitor the weight of each aerosol can as it is filled.
2. Perform fill weight checks at regular intervals (e.g., every 10th can or every 15 minutes) to ensure that the filling process is within the specified weight tolerance limits.
3. For manual systems:
   • Weigh each filled can using calibrated scales, ensuring that the weight is recorded.
   • Compare the recorded weight with the predefined tolerance limits specified for the product.
4. For automated systems:
   • Ensure that the automated weighing system records the weight of each can and alerts the operator if the weight is out of tolerance.
   • Verify the recorded weights for accuracy and consistency.
5. If a can is found to be out of tolerance:
   • Remove the non-conforming can from the production line.
   • Record the result in the Fill Weight Monitoring Log (Annexure-1).
   • Notify the QC team for investigation and corrective action.

5.3. Post-Test Actions

1. If the fill weight results are within the acceptable tolerance limits:
   • Continue the filling process and document the results in the Fill Weight Monitoring Log (Annexure-1).
   • Ensure that all data is reviewed and approved by the QC team.
2. If the fill weight results fall outside the acceptable limits:
   • Investigate the cause of the discrepancy (e.g., improper machine setup, incorrect formulation, equipment malfunction).
   • Take corrective actions as necessary, such as adjusting the filling machine settings, recalibrating equipment, or addressing any formulation issues.
   • Notify the QC team and document the corrective actions in the Corrective Action Log (Annexure-2).

5.4. Calibration and Maintenance of Equipment

1. Ensure that all weighing equipment used for monitoring fill weights is calibrated at regular intervals, according to the manufacturer’s guidelines and company procedures.
2. Perform routine maintenance on the weighing systems, ensuring that they are free from dust, contaminants, or mechanical issues that could affect their accuracy.
3. Document all calibration and maintenance activities in the Equipment Calibration Log (Annexure-3) and the Equipment Maintenance Log (Annexure-4).

5.5. Documentation and Record-Keeping

1. Document all fill weight monitoring activities, including the can ID, test date, weight recorded, operator name, and any corrective actions taken, in the Fill Weight Monitoring Log (Annexure-1).
2. Ensure that all records are reviewed by the QC team to confirm that the aerosol products meet the required fill weight specifications.
3. Store all records in the document management system, ensuring they are available for future reference and audits.

5.6. Safety and Environmental Considerations

1. Ensure that all personnel involved in the fill weight monitoring process wear the appropriate PPE to prevent exposure to aerosols and other materials used during filling.
2. Conduct all monitoring activities in a safe environment, ensuring that safety guidelines are followed for handling pressurized cans and other equipment.
3. Ensure proper disposal of any waste generated during the testing process, including non-conforming cans and other materials, according to environmental and safety regulations.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Fill Weight Monitoring Log (Annexure-1)
2. Corrective Action Log (Annexure-2)
3. Equipment Calibration Log (Annexure-3)
4. Equipment Maintenance 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

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Fill Weight Monitoring Log

Can ID	Test Date	Fill Weight (g)	Result	Operator Name	Remarks
C-12345	06/02/2025	120 g	Pass	Rajesh Patel	No issues found

Annexure-2: Corrective Action Log

Can ID	Issue Date	Issue Description	Corrective Action	Operator Name
C-12346	06/02/2025	Underfilled	Adjusted filling machine settings	Rajesh Patel

Annexure-3: Equipment Calibration Log

Equipment ID	Calibration Date	Calibration Results	Operator Name	Remarks
SCALE-001	06/02/2025	Pass	Rajesh Patel	No adjustments required

Annexure-4: Equipment Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Operator Name	Remarks
SCALE-001	06/02/2025	Cleaned and calibrated	Rajesh Patel	No issues found

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 fill weight monitoring procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures