What is a Pharmaceutical Drug Master File?
A drug master file is a document that’s curated
and prepared by the pharmaceutical manufacturer. This confidential file is then
submitted to the regulatory agency.
What is an API (Active Pharmaceutical Ingredient) Drug Master
File?
The pharmaceutical drug manufacturers usually prepare a
single drug masterfile, where information about the API used
in pharma drug is usually included. Though sometimes, they have to create a
separate API DMF, which is exclusively about the
USP and composition of the API used by the pharmaceutical drug
manufacturers.
What does a Drug Master File contain?
A drug master file is usually prepared after the completion of the
manufacturing process of a pharmaceutical drug. It includes factual and
confidential details of the facilities of the manufacturing plant, info on the
manufacturing process, active pharmaceutical ingredients and other inactive
ingredients used in preparing the pharmaceutical drug. The purity and impurity
of a pharmaceutical drug and what kind of internal and external environment it
was exposed to are also included in a pharmaceutical drug master drug file.
Importance of submitting a Pharmaceutical Drug Master File
The main reason the regulatory agency (FDA) asks the
pharmaceutical manufacturers to submit a Pharmaceutical DMF is to create a
culture of transparency within the health industry; the health of humans is at
stake, too.
Prerequisites of Submitting Drug Master File to Regulatory Agency
- Accurate specification of
API, excipients and other chemical substances
- Step-by-step explanation of
the drug’s manufacturing process
- Precisely described flavour,
colour, taste and side-effects
- Clear outlining of research
sampling points and procedures
- Proper profile of purity and
the safety of the pharmaceutical drug
- Description of the internal
& external setting of the manufacturing unit
- Steps taken to protect the
drug from the harsh weather conditions
- What & whys of the
materials used in the packaging of the drug
- A detailed and transparent
description of the final product
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