Standard Operating Procedure for Reviewing Batch Manufacturing Records (BMRs)

Department	Quality Control
SOP No.	SOP/QC/217/2025
Supersedes	SOP/QC/217/2022
Page No.	Page 1 of 5
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to define the procedure for reviewing Batch Manufacturing Records (BMRs) for capsules. This ensures that all manufacturing processes have been conducted in compliance with Good Manufacturing Practices (GMP) and regulatory requirements.

2. Scope

This SOP applies to the review process of BMRs for all capsule production batches. It includes verifying the accuracy of the recorded data, ensuring compliance with manufacturing protocols, and confirming that all necessary documents are complete and accurate.

3. Responsibilities

• Quality Control (QC) Team: Responsible for performing the review of the BMR, ensuring all manufacturing steps, materials, and quality control measures are accurately documented and compliant with internal and regulatory standards.
• Production Team: Responsible for ensuring that the BMR is completed accurately during the manufacturing process and is submitted to the QC team for review.
• Quality Assurance (QA) Team: Responsible for the final approval of the reviewed BMR and ensuring that the batch meets the required quality standards for release.

4. Accountability

The QC Manager is accountable for overseeing the BMR review process. The QA Manager is responsible for the final approval of the BMR before the batch is released for further processing or distribution.

5. Procedure

5.1 Review of BMR Submission

Before starting the review process, ensure the following:

1. Receive Completed BMR
   1. Ensure that the BMR has been fully completed by the Production team, including all necessary details such as batch number, raw materials, and manufacturing steps.
   2. Confirm that all sections of the BMR are signed and dated by the relevant personnel (e.g., production operators, quality control inspectors).
2. Verify Batch Information
   1. Ensure that the batch number, product name, and production dates are accurately recorded in the BMR.
   2. Verify that the batch size is consistent with the manufacturing order and production plan.
3. Check Raw Material Documentation
   1. Ensure that all raw materials used in the batch are correctly listed in the BMR with corresponding batch numbers, quantities used, and supplier details.
   2. Verify that the Certificate of Analysis (CoA) for each raw material is available and meets the required specifications.

5.2 In-Process Documentation Review

Review the documentation for in-process controls and manufacturing steps:

1. Check Manufacturing Process Documentation
   1. Verify that all manufacturing steps are documented and correspond to the approved process, including granulation, mixing, filling, and sealing.
   2. Ensure that any deviations from the approved manufacturing process are documented with appropriate explanations and corrective actions.
2. Review In-Process Testing Data
   1. Ensure that all in-process testing results, such as weight variation, dissolution, disintegration, and content uniformity, are accurately documented and meet the specifications.
   2. If any tests fail to meet specifications, ensure that the deviation has been addressed and corrective actions have been taken.

5.3 Review of Packaging Information

Ensure that all packaging details are correctly documented:

1. Check Packaging Information
   1. Verify that the type of packaging used (e.g., bottles, blister packs, foil pouches) is recorded accurately in the BMR.
   2. Ensure that the quantity of capsules packed and labeled is consistent with the batch size and production plan.
2. Ensure Correct Labeling
   1. Check that the labels used on the packaging include the correct batch number, product name, manufacturing date, expiry date, and any required regulatory information.

5.4 Final Review and Approval

Once the BMR has been thoroughly reviewed, proceed with the following steps:

1. Verify Compliance
   1. Ensure that the entire BMR is in compliance with GMP guidelines and regulatory requirements.
   2. Verify that the necessary signatures from the production, quality control, and quality assurance personnel are obtained.
2. Approval
   1. The QA team must approve the BMR for the batch to be released for further processing or distribution.
   2. Ensure that the approved BMR is stored according to the company’s record-keeping policies.

5.5 Documentation and Archiving

Once the BMR is approved, it must be properly archived:

1. Store BMRs
   1. Ensure that the BMR is stored in a secure location, where it can be easily accessed for future reference or audit purposes.
   2. Maintain BMRs for a period as required by regulatory authorities (typically 5 years).
2. Archive for Audits
   1. Ensure that BMRs are available for internal and external audits, as required by regulatory bodies.
   2. Ensure that any discrepancies or non-conformities are addressed prior to archiving.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• QC: Quality Control
• CoA: Certificate of Analysis

7. Documents

1. Annexure 1: Batch Manufacturing Record Template
2. Annexure 2: In-Process Testing Record
3. Annexure 3: Deviation Report

8. References

• Good Manufacturing Practice (GMP) Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

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 Template

Batch Number	Product Name	Batch Size	Manufacturing Date	Packaging Date	Remarks
Batch 001	Capsule A	10,000 units	01/03/2025	02/03/2025	Completed successfully

Annexure 2: In-Process Testing Record

Test Parameter	Initial Value	Test Date	Final Value	Remarks
Weight	0.5 g	01/03/2025	0.5 g	Within specification

Annexure 3: Deviation Report

Deviation ID	Batch Number	Deviation Date	Deviation Details	Corrective Actions	Resolved By
DEV-001	Batch 001	02/03/2025	Temperature deviation during storage	Adjusted chamber temperature	John Doe

12. Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version of SOP	Creation of SOP for BMR review	QA Head
01/02/2025	2.0	Updated documentation process for batch release	Incorporated packaging and in-process testing	QA Head