SOP Guide for Pharma

Capsule: SOP for Ensuring Compliance with Batch Manufacturing Records (BMRs) – V 2.0

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Capsule: SOP for Ensuring Compliance with Batch Manufacturing Records (BMRs) – V 2.0

Standard Operating Procedure for Ensuring Compliance with Batch Manufacturing Records (BMRs)

Department Capsule Manufacturing
SOP No. SOP/CM/083/2025
Supersedes SOP/CM/083/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to establish a procedure for ensuring compliance with Batch Manufacturing Records (BMRs) during capsule production. BMRs serve as a comprehensive record of the manufacturing process and ensure that all required steps, materials, and quality checks are completed according to regulatory and internal standards.

2. Scope

This SOP applies to all capsule manufacturing batches. It covers the steps required to ensure that all relevant documentation, materials, and procedures are followed and documented in the BMR during the production process. It includes proper filling, checking, and review of BMRs before and after the batch is manufactured.

3. Responsibilities

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that all BMRs are completed accurately and in compliance with this SOP. The QA Manager is responsible for reviewing the final BMR to ensure regulatory compliance and approval for batch release.

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5. Procedure

5.1 Preparation of Batch Manufacturing Records (BMRs)

Before starting the manufacturing process, the following steps must be taken to ensure the BMR is prepared and ready for use:

  1. Verify Batch Information
    1. Ensure that all necessary information, such as batch number, capsule type, formulation details, and production date, is included in the BMR template.
    2. Confirm that the BMR aligns with the product specifications, manufacturing instructions, and regulatory requirements.
  2. Assign Responsible Personnel
    1. Assign personnel to specific tasks outlined in the BMR, such as filling, weighing, and packaging. Ensure that all assigned personnel are trained and familiar with the requirements for their tasks.
  3. Ensure Availability of Equipment and Materials
    1. Verify that the required equipment and materials are available, calibrated, and ready for use. Ensure that the materials listed in the BMR match the actual materials to be used in the production process.

5.2 Completing BMR During Production

As the production process proceeds, ensure that the following actions are taken to maintain accurate and complete documentation in the BMR:

  1. Record Each Step in the BMR
    1. Document every step of the manufacturing process as it occurs. This includes equipment setup, material usage, environmental conditions, and in-process quality checks. Ensure that all steps are signed off by the responsible personnel.
  2. Document Adjustments and Deviations
    1. If there are any deviations from the standard operating procedure or unexpected adjustments to the manufacturing process, these must be documented in the BMR with a description of the reason for the change and any corrective actions taken.
  3. Sign and Date Entries
    1. Ensure that all entries in the BMR are signed and dated by the responsible personnel as soon as they are completed. This includes the signature of the operator, the supervisor, and the QC personnel for each completed task.
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5.3 Reviewing BMR Before Batch Release

Once the batch has been completed, the following review steps must be performed to ensure the BMR is complete and accurate:

  1. Initial Review by Production Supervisor
    1. The Production Supervisor should conduct an initial review of the BMR to ensure that all required sections have been completed, signed, and dated. Any missing or incomplete information should be addressed immediately.
  2. QC Review
    1. The QC team should review the BMR to ensure that all quality control checks, such as material inspections, weight checks, and batch samples, have been performed and documented. Ensure that any deviations from standard procedures are explained and that corrective actions have been taken.
  3. Final QA Approval
    1. The QA team should conduct a final review of the BMR to ensure that the batch complies with regulatory standards and internal quality guidelines. QA should verify that all documentation is complete, and the batch is suitable for release.

5.4 Handling Deviations and Non-Conformances

If any deviations or non-conformances are identified during the review of the BMR, the following steps should be taken:

  1. Document the Deviation
    1. Document the deviation in the deviation log, including a description of the issue, the root cause, and any corrective actions taken to address the issue.
  2. Implement Corrective Actions
    1. Implement any corrective actions necessary to address the deviation. This may include retraining personnel, adjusting machine settings, or improving procedures.
  3. Review and Approve Corrective Actions
    1. The QA team should review and approve any corrective actions taken before the batch is released for packaging. This ensures that all necessary steps have been followed to correct the deviation and prevent recurrence.
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5.5 Archiving and Retrieving BMRs

After the batch has been approved and released, the BMR must be archived as follows:

  1. Archive the BMR
    1. Archive the BMR in a secure location for the required retention period, as specified by regulatory guidelines. Ensure that BMRs are easily retrievable for audits or inspections.
  2. Maintain Backup Copies
    1. Ensure that backup copies of BMRs are maintained electronically or physically to prevent loss of records and to facilitate quick retrieval in case of audits or recalls.

6. Abbreviations

7. Documents

  1. Batch Production Record (BPR) (Annexure-1)
  2. Deviation Log (Annexure-2)
  3. Corrective Action Report (Annexure-3)

8. References

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 Production Record (BPR)

Batch ID Production Date Operator Name Quality Control Checks Approval Status
Batch 001 01/02/2025 John Doe Passed all QC checks Approved

Annexure-2: Deviation Log

Deviation ID Deviation Description Corrective Action Taken Approval Status
DEV-001 Incorrect temperature settings Recalibrated machine Approved

Annexure-3: Corrective Action Report

Action ID Action Description Responsible Person Completion Date
ACT-001 Machine calibration Jane Smith 02/02/2025

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated BMR compliance procedures Standardization QA Head
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