all BMRs, ensuring that all records are complete and compliant with regulatory requirements. QA also handles the final approval of the BMR before the batch is released for packaging.

Health and Safety Officer: Ensures that safety protocols are followed during the manufacturing process and that any safety-related issues are documented in the BMR.

4. Accountability

The Manufacturing Manager is accountable for ensuring that all BMRs are reviewed and approved in a timely manner, according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Completing the Batch Manufacturing Record

1. The production team is responsible for completing the BMR with accurate information during the production process. The BMR should include:
   • Batch number, date, and time of production
   • Raw materials used (including batch numbers and quantities)
   • Process parameters (e.g., temperature, pressure, flow rates)
   • Test results (e.g., fill weight, valve placement, aerosol performance)
   • Any deviations or non-conformances encountered during production
2. Ensure that all sections of the BMR are completed, with no missing information or incomplete entries.
3. After production is completed, the BMR should be signed off by the production operator and supervisor to confirm the accuracy of the documentation.

5.2. Review of the Batch Manufacturing Record

1. The QC team will review the BMR to verify the following:
   • All required fields have been filled in accurately and completely.
   • Test results meet the predefined specifications for product quality.
   • Any deviations or non-conformances are documented with appropriate corrective actions.
   • The batch complies with all regulatory and quality control standards.
2. QC will also verify that all materials used in production have been approved, and that no expired or non-conforming materials were used in the batch.
3. If any issues or discrepancies are found during the review, QC will communicate them to the production team for clarification or corrective action.

5.3. Approval of the Batch Manufacturing Record

1. Once the QC team has reviewed the BMR and confirmed that all requirements have been met, the BMR is forwarded to the QA team for final approval.
2. The QA team will perform a final review of the BMR to ensure that all documentation is accurate, complete, and compliant with GMP regulations.
3. If everything is in order, the QA team will approve the BMR, and the batch will be authorized for release for packaging.
4. If any issues are identified during the final review, the QA team will work with QC and production to resolve them before approval is granted.

5.4. Documentation and Record-Keeping

1. All completed BMRs, including signed approval forms, should be stored in the document management system for future reference and audits.
2. Ensure that the BMR is readily available for inspection by regulatory authorities or internal auditors as needed.
3. All records related to the batch, including raw material certificates of analysis, test results, and deviation reports, should be kept together with the BMR to ensure complete traceability.

5.5. Handling Deviations

1. If any deviations or non-conformances are identified during the review of the BMR, the deviation must be documented in the Deviation Log (Annexure-1).
2. For each deviation, a root cause investigation must be conducted, and corrective actions must be implemented. These actions should be recorded in the Corrective Action Log (Annexure-2).
3. The QA team is responsible for ensuring that all deviations are properly investigated and addressed before the batch is released for packaging.

5.6. Calibration and Maintenance of Equipment

1. Ensure that all equipment used during the manufacturing process, including measuring devices and testing equipment, is calibrated and properly maintained before production starts.
2. Document all calibration and maintenance activities in the Equipment Calibration Log (Annexure-3) and the Equipment Maintenance Log (Annexure-4).

5.7. Safety and Environmental Considerations

1. Ensure that all safety procedures are followed during production, particularly when handling hazardous materials or pressurized aerosol cans.
2. Ensure that the production area is cleaned and free from any residual materials after production to prevent contamination of the next batch.
3. Follow environmental guidelines for waste disposal and ensure that any materials that cannot be used or are expired are safely disposed of according to company policies.

6. Abbreviations

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

7. Documents

1. Batch Manufacturing Record (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action Log (Annexure-3)
4. Equipment Calibration Log (Annexure-4)
5. Equipment Maintenance 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-1: Batch Manufacturing Record

Batch Number	Raw Materials Used	Process Parameters	Test Results	Deviation Description	Corrective Action	Operator Name	Approval
Batch-001	200 kg	Temperature: 25°C, Pressure: 3 bar	Pass	No deviation	N/A	Rajesh Patel	Approved

Annexure-2: Deviation Log

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

Annexure-3: Corrective Action Log

Deviation ID	Corrective Action	Implementation Date	Operator Name	Outcome
DEV-12345	Re-calibrated filling machine	07/02/2025	Rajesh Patel	Resolved

Annexure-4: Equipment Calibration Log

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

Annexure-5: Equipment Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Operator Name	Remarks
FILL-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 review and approval procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures