machines, and labeling machines, are calibrated and maintained in optimal working condition.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the packing process parameters are monitored effectively. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Identification of Critical Packing Process Parameters

1. The QA team will define the critical packing process parameters for each aerosol product, including:
   • Fill weight
   • Sealing integrity
   • Labeling accuracy
   • Packaging material integrity
2. For each parameter, acceptable tolerance limits will be established. These tolerance limits should comply with regulatory guidelines and the product specifications.

5.2. Monitoring Fill Weight

1. The filling machine will be calibrated to ensure that the aerosol cans are filled with the correct amount of product. The fill weight should be monitored regularly by the packing team to ensure it remains within the specified limits.
2. The packing team will conduct periodic checks on the fill weights during production. If the weight deviates from the specified limits, corrective action should be taken immediately. Any deviations should be documented in the Fill Weight Deviation Log (Annexure-1).
3. At least one can from each batch should be selected for a fill weight check. The results should be documented in the Fill Weight Log (Annexure-2).

5.3. Monitoring Sealing Integrity

1. After filling, the cans will undergo sealing, and the sealing integrity will be checked by the packing team. This includes checking for proper crimping of the can tops and ensuring that there are no leaks.
2. The QA team will verify the sealing quality through random sampling of the packed aerosol cans. The sealing integrity should be checked using a leak tester or visual inspection methods.
3. If any cans fail the sealing inspection, they should be segregated and recorded in the Sealing Integrity Failure Log (Annexure-3).

5.4. Monitoring Labeling Accuracy

1. The packing team will apply labels to the cans as per the specified design. The labels should be inspected for:
   • Correct product information (e.g., batch number, manufacturing date, expiration date, warnings)
   • Proper label placement (centered, with no wrinkles or bubbles)
   • Clear legibility of all information
2. The QA team will periodically inspect a random sample of cans for label accuracy. Any labeling errors should be documented in the Labeling Error Log (Annexure-4) and corrective actions should be taken.

5.5. Monitoring Packaging Material Integrity

1. The packaging material used for secondary packaging (e.g., cartons, shrink wraps) should be inspected before use. Any defects, such as tears or holes, should be identified and reported to the packaging team.
2. The QA team will verify that all packaging materials are intact and free from defects before they are used for packing. If any defective materials are found, they should be segregated and documented in the Packaging Material Defect Log (Annexure-5).

5.6. Documentation and Record Keeping

1. All monitoring activities related to packing process parameters should be documented. The following logs should be used for recording the monitoring results:
   • Fill Weight Log (Annexure-2)
   • Sealing Integrity Failure Log (Annexure-3)
   • Labeling Error Log (Annexure-4)
   • Packaging Material Defect Log (Annexure-5)
2. Records should be signed and dated by the personnel involved in the monitoring process. These records should be stored in the document management system for future reference and regulatory audits.
3. Monitoring records should be retained for a minimum of 3 years or as required by regulatory guidelines.

5.7. Reporting and Compliance

1. If any issues or non-compliances are identified during the monitoring process, the QA team must be notified immediately. The QA team will investigate and ensure that corrective actions are taken before continuing with the packing process.
2. The QA team will review the packing process monitoring procedure during internal audits to ensure ongoing compliance with GMP and regulatory standards.

6. Abbreviations

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

7. Documents

1. Fill Weight Log (Annexure-2)
2. Sealing Integrity Failure Log (Annexure-3)
3. Labeling Error Log (Annexure-4)
4. Packaging Material Defect Log (Annexure-5)

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-2: Fill Weight Log

Batch Number	Test Date	Fill Weight	Pass/Fail	Operator Name
Batch-001	10/02/2025	500g	Pass	Rajesh Patel

Annexure-3: Sealing Integrity Failure Log

Batch Number	You said: Continue ChatGPT said: Here is the continuation of the SOP for Topic 98: SOP for Monitoring Packing Process Parameters: html Copy Edit	Failure Description	Action Taken	Operator Name	Approval
Batch-001	Loose seal detected	Re-sealed affected cans	Rajesh Patel	Approved

Annexure-4: Labeling Error Log

Batch Number	Error Type	Action Taken	Operator Name	Approval
Batch-001	Incorrect label applied	Re-labeled affected cans	Rajesh Patel	Approved

Annexure-5: Packaging Material Defect Log

Batch Number	Defect Type	Action Taken	Responsible Person	Status
Batch-001	Damaged carton	Rejected and replaced	Rajesh Patel	Completed

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