Standard Operating Procedure for Preparing Batch Manufacturing Records (BMR)

1) Purpose

The purpose of this SOP is to establish a procedure for the preparation of Batch Manufacturing Records (BMR) to ensure accurate documentation of the manufacturing process.

2) Scope

This SOP applies to all personnel involved in the preparation, review, and approval of BMRs within the manufacturing facility.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Production Personnel:

Responsible for accurately recording manufacturing data in the BMR.

3.2 Quality Assurance (QA) Personnel:

Responsible for reviewing and approving BMRs to ensure compliance with GMP standards.

4) Procedure

4.1 Preparation of BMR:

4.1.1 Use a standardized BMR template approved by the QA department.
4.1.2 Include all necessary information such as batch number, date of manufacture, and product name.
4.1.3 Record each step of the manufacturing process in detail, including equipment used, raw materials added, and process parameters.
4.1.4 Document any deviations or anomalies observed during manufacturing.

4.2 Review and Approval:

4.2.1 Submit the completed BMR to the QA department for review.
4.2.2 QA personnel must verify the accuracy and completeness of the BMR.
4.2.3 Address any discrepancies or missing information before final approval.
4.2.4 Approve the BMR for release only after ensuring all data is accurate and complete.

4.3 Archiving:

4.3.1 Store approved BMRs in a secure and easily retrievable location.
4.3.2 Maintain BMRs for the required retention period as specified by regulatory guidelines.
4.3.3 Ensure that BMRs are accessible for audits and inspections.

5) Abbreviations, if any

BMR – Batch Manufacturing Record
QA – Quality Assurance
GMP – Good Manufacturing Practices

6) Documents, if any

1. BMR Template
2. Approved BMRs
3. Review and Approval Logs

7) Reference, if any

1. FDA Guidance on Good Manufacturing Practices (GMP)
2. ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0