Drug master file (DMF) is set of documents submitted to food and drugs administration (FDA) by pharma manufacturer, the drug master file may also provide information which may be confidential for the company but may be required to be presented to regulatory authority for complete understanding of their product, facility, and the processes, systems, equipments and articles adapted for various of process of manufacturing and quality control and quality assurance, or storage and distribution.
A holder can permit or authorize other person to rely on data and information for various applications submissions.
It is not mandatory document for US FDA, but it is submitted by a pharmaceutical manufacturer to support their export application or (ANDA) Abbreviated New Drug Application, IND Investigational New Drug Application , or (NDA) New Drug Application. FDA reviews DMF only in context with these applications and an application for marketing a new drug in market.
These applications may reference the content to DMF wherever it is applicable. The drug master file is submitted to FDA in two copies, one copy must be retained by the person or holder who is submiting DMF.
US FDA classifies Drug master file DMF in to five types:
DMF provides information about manufacturing facility or Site, technical personnel’s working for the company and Operating Procedures.
This type of Drug master file DMF is required from conducting on site inspections out side of USA
It should describe
1. Site of manufacturing, actual address of site , and a map showing its geographical location.
2. Operational layout, with diagram of main processing or production arias.
3. Equipments and capabilities. Complete description about equipment capabilities and their applications.
Organization diagram, highlighting key on site and corporate Quality control and Quality assurance positions.
Type II Drug master file give information about drug molecule, its Intermediates, and starting material and intermediates used in the manufacturing of drug molecule and drug product.
For each packaging material complete information about their use, composition and components, and how they are controlled and released.
Details about name of supplier, their manufacturer too are required to be provided.
If required by drug product, one should also provide toxicological data about packaging material.
Drug master file provides information about packaging material used for packaging drug product.
Provides information about colorants additives, exceipients and flavors essences or substances used for manufacturing them.
Contains the information references which are accepted by FDA.It is required that a DMF to provide only one type of information and all data to support, different DMF’s may be cross referenced amongst themselves.
Though US FDA does not make it a mandatory document for any approval or disapproval , they have provided guidelines in section 21CFR314.420 about how DMF should be prepared and submitted .
21CFR314.420 states that a Drug master fileDMF for application in support of application for approval for marketing a new drug in market. should provide information about
1.) Drug molecule
2.) Drug molecule intermediates
3.) Packaging materials
8.) Or substances used to make them
9.) It also states that it should also provide complete list of persons who are authorized to incorporate any change in the DMF, and DMF holder may restrict a person to only a particular drug product.
10.) Stability data of drug product.
Different terms used for Drug master file
For submit ion to European countries it is called as Active Substance Master File (ASMF) European Drug Master File (EDMF) and it is also called US-Drug Master file (US-DMF) in United States.
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