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The MFR is a set of instructions that tells you how to produce a product batch, while the BMR records what you actually produced. Think of this process like baking a cake: The MFR is your recipe, telling you how much flour to put in, how many eggs to add, how long to cook it for and at what temperature.

A batch manufacturing record is a document designed to provide a complete record of the manufacturing history of a batch of product. The terminology is widely applied within the Pharmaceutical & Chemical industries and is referenced in many of the pharmaceutical and food regulatory agency requirements.

The MFR serves as a master document and is used as a reference for creating batch-specific documents, such as Batch Formula Records (BFRs), which contain specific instructions and records for each manufacturing batch.

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.

What is a Master Formulation Record? A Master Formulation Record is used to document the specific information for each individual batch and is an important component of regulatory compliance and effective process control. This detailed record of procedures describes how the drug product is to be prepared.

Description of ingredients, their quantities and sources (e.g., physical description, DIN, manufacturer, etc.) Quality control procedures and expected results (e.g., weight range of filled capsules, pH of aqueous liquids, etc.) Mixing instructions and methods, which may include: order of mixing.

MASTER FORMULA RECORD ? Master Formula Record (MFR) is a master document for any pharmaceutical product. ? MFR contains all information about the manufacturing process for the product. ? MFR is prepared by the research and development team of the company.