Batch Formula Record (BFR) / Batch Manufacturing Record (BMR)
- A Batch Formula Record (BFR), also known as the Batch Manufacturing Record (BMR), is a document that provides a detailed history of a specific batch of a pharmaceutical product from start to finish.
Purpose of BFR/BMR
- Ensures consistency and uniformity in drug production.
- Provides a legal record of production.
- Assists in troubleshooting production issues.
- Essential for regulatory audits and inspections.
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Contents of BFR/BMR
- Batch Number: Unique identifier for the batch.
- Product Name and Strength.
- Manufacturing Date and Expiry Date.
- List of Raw Materials with quantities and specifications.
- Processing Instructions (mixing, drying, granulation, etc.).
- In-Process Control Tests (e.g., weight variation, hardness, dissolution).
- Packaging and Labeling Details.
- Signatures of Responsible Personnel at each stage.
- Yield Calculation to ensure no loss of materials.
- Deviation and Incident Reporting (if any).
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