in good working condition, calibrated properly, and free of defects that could cause inconsistent filling.

Health and Safety Officer: Ensures that all safety protocols are followed during the filling process, particularly when dealing with overfills or underfills involving propellants or hazardous chemicals.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that overfills and underfills are appropriately addressed during aerosol filling. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Identifying Overfills and Underfills

1. During the filling process, regularly check the weight of filled cans to ensure they fall within the acceptable fill range specified for the product.
2. Perform weight checks by using calibrated scales to measure the amount of product filled into each aerosol can. The target weight should be defined by the product specifications.
3. Visual inspections should also be carried out to check for any obvious signs of overfilling or underfilling, such as liquid spillage or underweight cans.
4. Record the results of the checks in the In-Process Testing Log (Annexure-1). Document any deviations from the standard weight, such as overfill or underfill occurrences.

5.2. Handling Overfills

1. If overfills are identified (i.e., the amount of product exceeds the specified fill level), immediately stop the filling process to prevent further overfilling.
2. Adjust the filling equipment settings (e.g., pressure, time) to ensure that the correct fill volume is dispensed into the cans. This may include calibrating the filling machine or adjusting the volume control mechanism.
3. Dispose of any excess product or waste generated due to overfills according to the company’s waste disposal procedures.
4. Once the equipment has been adjusted, resume the filling process and recheck the cans for correct fill levels. Continue monitoring to ensure that overfilling does not occur again.
5. Record the corrective actions taken in the Filling Deviation Log (Annexure-2). This log should include the batch number, the cause of the overfill, and the corrective measures implemented.

5.3. Handling Underfills

1. If underfills are detected (i.e., the can has less than the required fill volume), stop the filling process immediately and investigate the cause of the underfill.
2. Check the filling equipment to identify potential causes of the underfill, such as equipment malfunction, improper settings, or incorrect product flow rates.
3. Adjust the equipment settings to restore the correct fill volume. This may include adjusting the filling machine’s settings, such as pressure, time, or the flow rate of the product.
4. Once the equipment has been adjusted, resume filling the cans. Perform weight checks on a sample of the cans to ensure that the proper volume is being dispensed.
5. Record the corrective actions taken in the Filling Deviation Log (Annexure-2), including the batch number, the cause of the underfill, and the corrective measures implemented.

5.4. In-Process Monitoring and Quality Control

1. Throughout the filling process, continue to monitor the filled cans for consistency and accuracy in fill levels. Perform weight checks and visual inspections regularly to identify any potential overfill or underfill issues.
2. If any further deviations are noticed, stop the process and investigate the cause of the issue. Ensure that the filling equipment is functioning correctly and adjust as necessary to maintain the required fill level.
3. Document the results of all weight checks, adjustments, and quality control activities in the In-Process Testing Log (Annexure-1) and the Filling Deviation Log (Annexure-2).

5.5. Post-Filling Quality Assurance

1. Once the filling process is complete, perform final checks on the filled cans to ensure that they meet the required specifications for weight, appearance, and sealing integrity.
2. If any cans are identified as overfilled or underfilled during the final inspection, they should be segregated and either reprocessed or discarded, depending on the extent of the deviation and the company’s procedures.
3. Ensure that all final product cans are sealed properly to prevent contamination or leakage and that the filled product is ready for the next phase of manufacturing, such as labeling and packaging.

5.6. Documentation and Record-Keeping

1. Document all weight checks, deviations, and corrective actions in the relevant logs, including:
   • In-Process Testing Log (Annexure-1)
   • Filling Deviation Log (Annexure-2)
   • Final Quality Check Log (Annexure-3)
2. Ensure that all records are stored according to the company’s document retention policy and 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. In-Process Testing Log (Annexure-1)
2. Filling Deviation Log (Annexure-2)
3. Final Quality Check 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 9001:2015 – 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

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 overfill and underfill process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures