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

• Production Operators: Responsible for completing the BMR accurately during the manufacturing process and ensuring that all steps are documented as they occur.
• Quality Control (QC) Team: Responsible for reviewing the BMRs to ensure that all required checks, tests, and procedures have been properly followed and documented before batch release.
• Quality Assurance (QA) Team: Ensures overall compliance with regulatory guidelines and company standards, conducts final review and approval of BMRs before releasing the batch for packaging.
• Production Supervisor: Responsible for ensuring that the production team adheres to the BMR requirements and that any discrepancies are addressed promptly.

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.

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.

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.

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

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• BPR: Batch Production Record

7. Documents

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

8. References

• USP <1163> – Pharmaceutical Dosage Forms: Capsules
• FDA Guidelines for Capsule Manufacturing
• International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Manufacturing

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