released products comply with regulatory requirements and that any necessary notifications or reports are made to regulatory authorities.

4. Accountability

The Manufacturing Manager is accountable for ensuring that finished aerosol products meet all release criteria and comply with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Completion of Manufacturing and Final Inspection

1. The production team will complete the manufacturing process, including filling, packaging, labeling, and final inspection of the aerosol products. All work must be documented in the batch records.
2. The production team will perform a final inspection of each batch to ensure that the aerosol cans are properly sealed, labeled, and meet packaging specifications.
3. If the batch is found to have any defects during the final inspection (e.g., labeling errors, leaks, or underfills), the batch will be segregated and flagged for investigation. The deviation should be documented in the Deviation Log (Annexure-1).

5.2. Review of Batch Records

1. The QA team will review the batch records, which should include:
   • Raw material usage logs
   • Production and packaging parameters
   • Test results (e.g., fill weights, valve testing, leak testing)
   • Operator and supervisor signatures
   • Cleaning and maintenance records for the equipment used
2. QA will ensure that all required testing has been completed and that the results are within the specified limits.
3. If any discrepancies or missing information are found during the review, the batch will not be approved for release until corrective actions have been taken. The issue should be documented in the Non-Conformance Log (Annexure-2).

5.3. Quality Control Testing

1. QC will conduct final testing on the finished aerosol products, including:
   • Fill weights and volume checks
   • Valve performance testing
   • Pressure testing
   • Microbial testing (if applicable)
2. All QC test results must be documented in the QC Testing Log (Annexure-3) and reviewed by the QA team for compliance with product specifications.
3. If the QC results do not meet specifications, the batch will not be released, and corrective actions must be taken. The corrective actions and their outcomes should be documented in the Corrective Action Log (Annexure-4).

5.4. Approval for Release

1. Once all batch records and QC testing results are reviewed and found to be compliant, the QA team will approve the batch for release. The approval will be documented in the Release Approval Log (Annexure-5).
2. All relevant documents, including batch records, QC test results, and approval forms, should be stored in the document management system for easy retrieval and regulatory inspection.
3. If the batch does not meet the required standards or if any deviations are unresolved, the batch will not be approved for release, and the corrective actions will be taken as needed.

5.5. Documentation and Record-Keeping

1. The QA team will ensure that all records related to the batch release process, including batch records, QC test results, deviations, and corrective actions, are properly documented and stored for future reference and audits.
2. Records must be retained for a minimum of 3 years or as required by regulatory guidelines.

5.6. Reporting and Notification to Regulatory Authorities

1. If any regulatory issues are identified during the review or testing process, the Regulatory Affairs Team must be notified immediately. The Regulatory Affairs Team will determine if a report or notification to regulatory authorities is necessary.
2. For batches with significant issues, the QA team must document the problem, corrective actions, and any communications with regulatory authorities in the Incident Report Log (Annexure-6).

6. Abbreviations

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

7. Documents

1. Deviation Log (Annexure-1)
2. Non-Conformance Log (Annexure-2)
3. QC Testing Log (Annexure-3)
4. Corrective Action Log (Annexure-4)
5. Release Approval Log (Annexure-5)
6. Incident Report Log (Annexure-6)

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: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Operator Name	Approval
DEV-12345	Underfill detected	Adjusted filling machine settings	Rajesh Patel	Approved

Annexure-2: Non-Conformance Log

Non-Conformance ID	Non-Conformance Description	Corrective Action	Responsible Person	Status
NC-001	Improper temperature during filling	Re-calibrated temperature control	Rajesh Patel	Completed

Annexure-3: QC Testing Log

Batch Number	Test Type	Test Result	Passed/Failed
Batch-001	Fill weight	500 g	Pass

Annexure-4: Corrective Action Log

Deviation ID	Corrective Action	Implementation Date	Responsible Person	Status
DEV-12345	Re-calibrated filling machine	07/02/2025	Rajesh Patel	Completed

Annexure-5: Release Approval Log

Batch Number	Approval Date	Approving Authority	Comments
Batch-001	10/02/2025	Anjali Sharma	Approved for release

Annexure-6: Incident Report Log

Incident ID	Incident Description	Action Taken	Outcome
INC-001	Labeling error detected	Re-labeled affected products	Resolved, no further 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 release procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures