What is the Drug Master File (DMF)?
Drug Master File (DMF) is a document provided by the manufacturer submission to the Food and Drug Administration (FDA) may be used to provide confidential information about facility, processing,or articles used in manufacturing processing, packaging, and storing of the one or more human drug.
By the law or FDA regulation submission of the DMF is not required. DMF submission is the full interest of drug holders.
Which guidelines state about Dug Master File?
In this chapter, it is mentioned about the submission of DMF.
What is the Food and Drug Administration (FDA)?
Food and Drug Administration (FDA) is federal agency of United States of America (USA) department of health and human services. It is one of the executive department of USA.
What is the role of the Food and Drug Administration (US-FDA)?
FDA is a government body of the USA established in 1906. FDA is responsible for the protection of public health by ensuring the Quality, Safety, and Efficacy of drugs for human and veterinary purposes in the US market.
USFDA gives approval for new products to market the product in the US by confirmation of product quality.
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How many types of Drug Master Files (DMF)?
According to their functionality, there are a total of five types of Drug Master File in pharmaceutical.
What are the types of Drug master files?
DMF Type I –
The DMF type I contains information of manufacturing facility, operating procedure, and personnel.
DMF Type II –
The DMF type II contains information about the single drug, single product, drug substance intermediate, and material used in the preparation.
Type II DMF includes some of the general points, those are:
a. Manufacturing section
b. Quality control
i. Input ( Raw material/packing material)
ii. Intermediate and in process
iii. Finished drug substance
d. Stability Data
f. Packaging and Labelling
DMF Type III –
The DMF type III contains information on packing material.
DMF Type IV –
The DMF type IV contains information about helping agents such as excipient, colorant, flavor, and essence.
DMF Type V –
Type V DMF usually contains clinical data, toxicity data.
What is the advantage of DMF?
Why Submission is Needed?
The main objective of DMF submission is to support regulatory requirements and to prove the Quality, Safety, and Efficacy of the medicinal product for obtaining an NDA, ANDA, another DMF, or as an export application.
Information Of DMF:
In the guideline, some basic information mentioned that needs to follow.
● DMF must be submitted in two copies, one is blue cover and the other in a red cover.
● Each page of each copy of the DMF should be dated and consecutively numbered.
● The paper must have a standard size. The paper length should be Not less than 10 inches and Not more than 12 inches.
● DMF should be in multiple volumes and each volume should be Not more than 2 inches thick.
Types of Drug Submission in US, Canada & EU:
The USA– NDA for a new drug, ANDA for Generic and Biologic Licence Application (BLA) for Biologic product.
Canada– New Drug Submission (NDS) for both new drug and biologic products.
EU-Marketing Authority Application (MAA) via the centralized product for digital products. And for other products via the decentralized, mutual recognition or National Authorization is applicable.
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