Standard Operating Procedure for Batch Manufacturing Record for Granules

1) Purpose

The purpose of this SOP is to provide guidelines for documenting and maintaining batch manufacturing records (BMR) for granules in the pharmaceutical industry to ensure traceability, consistency, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the preparation and documentation of batch manufacturing records for granules within the pharmaceutical manufacturing department.

3) Responsibilities

Production Supervisor: Responsible for overseeing the batch manufacturing process and documentation.
Quality Assurance (QA) Officer: Responsible for reviewing and approving batch records.

4) Procedure

1. Preparation Before Production:
   1. Retrieve the approved Master Formula Record (MFR) and Batch Processing Record (BPR).
   2. Gather all required raw materials, packaging materials, and equipment.
2. Batch Record Documentation:
   1. Record all critical information including batch number, date, start and end times, and personnel involved.
   2. Document each step of the manufacturing process, including blending, granulation, drying, and packaging.
   3. Record in-process testing results and deviations, if any.
3. Review and Approval:
   1. Review the completed batch record for accuracy, completeness, and compliance with SOPs.
   2. Obtain QA approval before proceeding to the next stage or packaging.
4. Batch Release:
   1. Once QA approval is received, release the batch for further processing or packaging.
   2. Label each batch container with appropriate batch number and expiry date.
5. Documentation Retention:
   1. Maintain batch records in a secure location as per regulatory requirements.
   2. Ensure records are readily accessible for inspections and audits.

5) Abbreviations, if any

SOP: Standard Operating Procedure
BMR: Batch Manufacturing Record
MFR: Master Formula Record
BPR: Batch Processing Record
QA: Quality Assurance

6) Documents, if any

Master Formula Record (MFR), Batch Processing Record (BPR), In-process Testing Results, QA Approval Documentation

7) Reference, if any

Current Good Manufacturing Practices (cGMP) guidelines for pharmaceutical manufacturing.

8) SOP Version

Version 1.0