Organize Formula Record For Free

Master formula record (MFR) is a master document for any pharmaceutical product. It contains all information about the manufacturing process for the product.

A master batch record (MBR), also known as a master production record (MPR) is a document that contains the approved ingredients, formulation, and instructions guiding the production of a pharmaceutical product.

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.

Pharmacists are required to document the following information in a master formulation record when compounding a drug using either sterile or non-sterile techniques: Name, dosage, and strength of the drug. Calculations used. Ingredients and quantities. Equipment used. Step-by-step instructions of how the drug was compounded.

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.

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 Master Formula Record should include: the name of the product, with a product reference code relating to its specification; a description of the dosage form, strength of the product. batch size. Shelf Life. Storage Condition.