📘 Preparation of Master Formula Record (MFR)

A Master Formula Record (MFR) is a controlled document that serves as a blueprint for manufacturing a pharmaceutical product. It ensures product quality, consistency, and compliance with regulatory requirements.

🔑 Key Steps in Preparation of MFR:

1. Product Information

   • Product name, dosage form, strength, batch size.

   • Unique document reference number.

2. List of Materials

   • Active pharmaceutical ingredient (API) and excipients.

   • Grades, specifications, and approved suppliers.

   • Exact quantities with tolerances.

3. Equipment and Instruments

   • List of required equipment, capacity, and identification numbers.

   • Special tools or accessories (if any).

4. Manufacturing Instructions

   • Step-by-step procedure for dispensing, processing, and blending.

   • Environmental conditions (temperature, humidity).

   • Safety precautions during handling.

5. Packaging Instructions

   • Packaging materials, container/closure system.

   • Labeling instructions with version control.

6. In-Process Controls (IPQC)

   • Sampling and testing requirements at critical stages.

   • Limits and corrective actions.

7. Yield and Reconciliation

   • Theoretical yield and acceptable ranges.

   • Instructions for reconciliation of raw materials and finished goods.

8. Approval & Authorization

   • Reviewed and approved by Quality Assurance (QA).

   • Signatures from Production, QA, and Regulatory departments.

✅ Importance of MFR:

• Ensures standardization and reproducibility of batches.

• Helps maintain regulatory compliance (FDA, WHO, EU GMP).

• Minimizes errors, deviations, and product mix-ups.

• Supports audit readiness and traceability.

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