for post-fill checks is properly calibrated and functioning correctly.

Health and Safety Officer: Ensures that safety protocols are followed during the weight check process, particularly when handling pressurized cans.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed during post-fill weight checks. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparation for Post-Fill Weight Checks

1. Ensure that all necessary equipment for the weight checks, including calibrated scales, are available and properly set up.
2. Ensure that the filling machine has been calibrated and is operating within the specified parameters before the weight check process begins.
3. Verify that operators are trained in the proper techniques for conducting weight checks and handling aerosol cans safely.
4. Prepare a sample of cans to be checked. The sample size should comply with the company’s standard operating procedure for sampling and may depend on the batch size.

5.2. Performing Post-Fill Weight Checks

1. Once the aerosol cans are filled, remove a sample from the production line and place them on a calibrated scale.
2. Weigh each can individually to determine if it meets the required target weight. The target weight should be specified on the product specification sheet.
3. Ensure that each can is weighed on the same scale to maintain consistency and accuracy. Record the weight of each can in the Post-Fill Weight Check Log (Annexure-1).
4. If the weight of any can is found to be outside the acceptable weight tolerance (both overfill and underfill), stop the filling process immediately and investigate the cause of the discrepancy.

5.3. Handling Discrepancies (Overfill or Underfill)

1. If a can is overfilled (i.e., exceeds the acceptable weight), adjust the filling equipment settings to reduce the fill volume and prevent further overfills.
2. If a can is underfilled (i.e., weighs less than the required weight), investigate the cause and make the necessary adjustments to the filling machine, such as adjusting the product flow rate or filling time.
3. Once adjustments are made, continue the filling process and recheck the weight of additional cans to ensure that the issue has been corrected.
4. Document the results of the corrective actions taken in the Post-Fill Weight Adjustment Log (Annexure-2).

5.4. In-Process Monitoring and Quality Control

1. During the post-fill weight check process, randomly sample additional cans to verify the consistency of the fill weight.
2. If significant variations are observed in the weight checks, stop production and conduct a more thorough investigation of the filling process.
3. Maintain accurate records of all weight checks, including the batch number, product specifications, weight results, and corrective actions taken.
4. Record any discrepancies and corrective actions in the Post-Fill Weight Check Log (Annexure-1) and the Post-Fill Weight Adjustment Log (Annexure-2).

5.5. Post-Fill Inspection

1. After the weight checks are completed and any necessary adjustments are made, perform a final visual inspection of the cans to ensure that there is no leakage, damage, or other defects.
2. Ensure that all cans that have passed the weight check are correctly labeled and transferred to the next stage of the production process (e.g., sealing, packaging).
3. Any cans that fail the weight check or show signs of defects should be segregated and either reworked or discarded as per company policy.

5.6. Documentation and Record-Keeping

1. Ensure that all weight check results, including both acceptable and rejected cans, are documented in the Post-Fill Weight Check Log (Annexure-1).
2. Record any corrective actions taken and adjustments made in the Post-Fill Weight Adjustment Log (Annexure-2).
3. Maintain all weight check records and batch logs according to the company’s document retention policy and ensure 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. Post-Fill Weight Check Log (Annexure-1)
2. Post-Fill Weight Adjustment 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: Post-Fill Weight Check Log

Batch No.	Can Number	Weight	Pass/Fail	Operator Name
12345	1	100g	Pass	Rajesh Patel
12345	2	99.5g	Pass	Rajesh Patel

Annexure-2: Post-Fill Weight Adjustment Log

Batch No.	Adjustment Description	Adjustment Date	Operator Name
12345	Increased fill pressure to correct underfill	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 weight check procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures