Master Formula Record (MFR)
- The Master Formula Record (MFR), also called the Master Manufacturing Formula (MMF), serves as the approved blueprint for manufacturing each pharmaceutical product.
Purpose of MFR
- Provides a standardized recipe for drug production.
- Ensures quality and consistency across all batches.
- Helps in regulatory approvals and audits.
Contents of MFR
- Product Name, Dosage Form, and Strength.
- Complete List of Ingredients with exact quantities.
- Manufacturing Process with precise instructions.
- Quality Control (QC) Specifications and Testing Methods.
- Packaging and Storage Conditions.
- Stability Testing Requirements.
- In-Process and Finished Product Testing Criteria.
- Approval Signatures of the QA, QC, and Production Departments.
Each batch of a drug product is manufactured following the Master Formula Record, and its compliance is documented in the Batch Manufacturing Record (BMR).
