What is a master formula record?

1. Introduction:  In the Pharmaceutical industry, for every product, there is a master formula record that includes the specifications of the product, dose, dosage form, uses, manufacturing process, materials used and their quantities, etc. MFR is a very important document and in this article, we are going to the contents of the master formula record and who prepares everything in detail.

2. Responsible Departments for preparation of master formula record: a) Formulation R&D, Production b) Quality Assurance

3. Format: The MFR is made in proper format in the form of a formal document with the company name, Name of the product, Batch size, document number along with revision number, and the manufacturing site address and approval signatures of the concerned departments.

Note: even though MFR contains detailed instructions on the Manufacturing process these are not referred as SOP

4. Contents of Master Formula Record: 

The master formula mainly contains all the information of the product starting from the raw materials along with their quantities, packing materials, and detailed description of the procedures which are requisite for getting a finished product along with the in-process controls.

a) Name of product, Reference code of the product, specifications

b) Product patent / proprietary name, generic name, dosage form description, strength, composition, and importantly batch size.

here, what we have to know is there must be a separate MFR for each batch size. and these are the contents present in the master formula record.

c) Processing location and equipment information

d) Name of the raw material, their quantity, specifications,

e) statements regarding expected final yield, limits, etc.

f)  Methods used for cleaning equipment, their preparation, and calibration process.

g) Written instructions step by step along with the time that will be consumed for each step.

h) in process checks and their limits

i) storage condition requirement of the product, labeling etc.

j) Any special precautions to be taken

k) Packing details and specimen labels of the respective product

in the next article, we are going to see, how to prepare a master formula record. Happy learning