Master formula record (MFR) is a master document for any pharmaceutical product. It contains all information about the manufacturing process for the product. MFR is prepared by the research and development team of the company and all other documents like BMR and BPR are prepared using MFR by the manufacturing units.
1. Product Details: First of all on the first page following details about the product are added.
Name, logo and address of the manufacturing company
Dosage form name
Label claim of all ingredients
Pack size and packing style
MFR number and date
Supersede MFR number and date
Effective batch number
Authorization by the production and quality assurance head
2. Flow Chart: Steps of the manufacturing process to be monitored. Flow chart of the material movement from dispensing to the final product to stores.
3. Equipments: Create a list of all required equipments and machines required in the manufacturing process with their capacity.
4. Special instructions: Write down the precautions special instructions to follow during the product manufacturing and packing and these should also be added in the batch manufacturing formula. Batch manufacturing formula should include the following.
Name of ingredients with test reference (As IP, BP, USP etc.)
Quantity to be added
Overages to be added (%)
5. Calculations: Include the calculation steps of all active materials to get the 100% of the active material. Calculation shall be done using water content or LOD to get 100% potency.
6. Manufacturing Process: Write all steps in all stages of the manufacturing process. All process steps like shifting, milling, mixing, lubricating, granulation, compression and coating should be written in detail including the process time and yield. Include atmospheric conditions as temperature, humidity and storage conditions for every step.
7. Packing Process: List of all packing materials with their quantity is written. Line clearance, reconciliation of printed and unprinted packing materials should be included in details.
8. Yield: Include the theoretical, actual yield and acceptance limit of the batch.
Detail given above should be included in a general master formula record. Other details should be added as per company requirements in the master formula record.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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