team also ensures that any deviations are properly documented and corrective actions are taken as needed.

Engineering Team: Responsible for ensuring that any equipment used in the production process is functioning correctly and is properly documented in the batch manufacturing record.

Warehouse Team: Responsible for ensuring that materials used in the batch are accurately tracked and documented in the BMR, and that the correct materials are available and used in the production process.

4. Accountability

The Manufacturing Manager is accountable for ensuring that batch manufacturing records are prepared and maintained according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing the Batch Manufacturing Record

1. Prior to the start of the manufacturing process, prepare a batch manufacturing record for the specific aerosol product to be produced. The BMR should include the following information:
   • Batch number
   • Product name and code
   • Manufacturing date and time
   • List of raw materials used, including their batch numbers and quantities
   • Equipment used (e.g., mixers, filling machines, etc.)
   • Production personnel involved in the process
   • Any relevant quality control or testing procedures to be performed
2. Ensure that the batch manufacturing record is aligned with the approved master batch record for the product, which includes the detailed manufacturing process steps and controls.
3. During the production process, ensure that all required data is entered into the batch manufacturing record. This includes:
   • Raw material lot numbers and quantities used
   • Equipment calibration and usage logs
   • Process parameters (e.g., temperature, pressure, mixing time) and any deviations observed
   • In-process testing results (e.g., weight checks, fill volume tests, etc.)
   • Any adjustments or deviations from the standard process and corrective actions taken

5.2. Documenting Deviation and Corrective Action

1. If any deviations from the standard process are encountered during production, they must be documented in the deviation section of the batch manufacturing record. The following information should be included:
   • A description of the deviation
   • The cause of the deviation (if known)
   • The corrective actions taken to address the deviation
   • Any impact on the final product or process
   • Approval of the corrective actions by the QA team
2. Ensure that any corrective actions taken are documented in the Corrective Action Log (Annexure-2) and that any necessary investigations are conducted to determine the root cause of the deviation.

5.3. Finalizing and Reviewing the Batch Manufacturing Record

1. Once the production process is complete, finalize the batch manufacturing record. Ensure that all sections of the BMR are filled out correctly, and that all required signatures are obtained, including signatures from production personnel, QA personnel, and any other relevant team members.
2. The QA team should perform a thorough review of the batch manufacturing record to ensure that it is complete, accurate, and in compliance with regulatory and GMP requirements. The review should include checking the following:
   • Completeness of the record
   • Accuracy of the data entered
   • Appropriate documentation of deviations and corrective actions
   • Verification of in-process test results
3. Once the QA team completes the review, the batch manufacturing record should be approved and signed off by the QA team. Any unresolved issues or deviations should be addressed before approval.

5.4. Archiving the Batch Manufacturing Record

1. Once the batch manufacturing record has been finalized and approved, it should be stored in a secure and organized manner for future reference, audits, or regulatory inspections.
2. Ensure that all batch manufacturing records are retained for the required duration according to company policy and regulatory requirements.
3. Make sure that batch records are accessible to authorized personnel when needed for audits, investigations, or inspections.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• BMR: Batch Manufacturing Record
• QC: Quality Control

7. Documents

1. Batch Manufacturing Record (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action 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 – 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	Product Name	Manufacturing Date	Raw Materials Used	Equipment Used	Test Results	Deviation
BN-12345	Aerosol Spray	06/02/2025	Water-001, Gas-002	Filling Machine-01	Pass	N/A

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Pressure deviation during filling	Adjusted pressure settings	Rajesh Patel	Completed

Annexure-3: Corrective Action Log

Action ID	Action Description	Responsible Person	Completion Date
CA-12345	Recalibrated filling machine pressure	Rajesh Patel	06/02/2025

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 batch manufacturing record format	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures