Design Formula Record For Free

The MFR is a set of instructions that tells you how to produce a product batch, while the BMR records what you actually produced.

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.

A MFR should have following parts: Product Details: First of all on the first page following details about the product are added.Flow Chart: Steps of the manufacturing process to be monitored.Equipment: Create a list of all required equipment and machines required in the manufacturing process with their capacity.

The master formula is for 100 g, the prescription is for 50 g, therefore the multiplying factor is 50/100, i.e. each quantity in the master formula is multiplied by 50/100 = 0.5 to give the scaled quantity....Calculating quantities from a master formula. IngredientMaster formulaScaled quantityWaterto 10 mLto 200 mL3 more rows ?

A key provision of the regulations describes requirements for creating a master formula document, which is the specific recipe prepared in writing by a pharmacy before compounding any preparation.

In order to prepare a compounded medication a pharmacy must have a set of instructions that include an ingredient list and preparation/preparatory instructions. In the compounding pharmacy this document is called the Master Formulation Record (MFR). It is comparable to a ?recipe? in cooking.

(a) name of the product; (b) description of the dose form; (c) the relevant tests for final release of the finished product and their acceptance criteria; (d) type of container and closure of the product; (e) storage conditions and any special handling precautions, if applicable; and (f) shelf-life of the product.