📘 Preparation of Master Formula Record (MFR)

📌 What is MFR?

• A Master Formula Record (MFR) is a controlled document that provides the recipe, manufacturing process, equipment, materials, and in-process controls required to produce a pharmaceutical product.

• It is mandated by GMP (21 CFR Part 211, WHO, EU GMP) to ensure consistency, quality, and regulatory compliance.

• From MFR, Batch Manufacturing Records (BMR) are derived.

📌 Key Components of an MFR

1. General Information

   • Product name, dosage form, strength.

   • Product code / MFR number / version number.

   • Batch size (standard batch).

   • Shelf life and storage conditions.

2. List of Raw Materials

   • Active Pharmaceutical Ingredient (API) and excipients.

   • Grade (pharma grade, analytical grade).

   • Approved vendors and specifications.

   • Precise quantities per batch size (with overages, if applicable).

3. List of Packaging Materials

   • Primary, secondary, and tertiary packaging components.

   • Pack size configurations.

4. Equipment Details

   • List of equipment with unique ID numbers.

   • Capacity requirements (blender, granulator, compression machine, coating pan, etc.).

5. Manufacturing Process & Instructions

   • Stepwise procedure (dispensing, granulation, drying, compression, coating, filling, sterilization, etc.).

   • Critical process parameters (CPPs).

   • Environmental conditions (for sterile products).

6. In-Process Controls (IPQC)

   • Sampling and testing points (e.g., blend uniformity, tablet weight variation, hardness, friability, disintegration, sterility tests).

   • Frequency of checks.

7. Yield Calculations

   • Theoretical yield vs. acceptable limits.

   • Reconciliation of materials.

8. Special Precautions & Safety Measures

   • Handling of hazardous/toxic materials.

   • Cross-contamination prevention measures.

9. Approval Signatures

   • Prepared by (Production/QA).

   • Reviewed by (Quality Control, Regulatory).

   • Approved by (Head QA/QC/Regulatory).

📌 Procedure for Preparation of MFR

1. Draft prepared by Production/Development team.

2. Review by Quality Assurance and Regulatory Affairs.

3. Check alignment with Product Development Report (PDR).

4. Verify compliance with pharmacopoeial standards & regulatory filings (ANDA, DMF, MA file).

5. Controlled copy issuance under Document Control SOP.

6. Training of production staff before implementation.

✅ Importance of MFR in Pharmaceuticals

• Ensures batch-to-batch consistency.

• Serves as a reference during manufacturing, deviations, investigations.

• Reduces human error by providing clear instructions.

• Facilitates regulatory inspections (FDA, EMA, WHO).

• Strengthens data integrity & traceability.

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