Drug Master File (DMF)
Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and
submitted solely at its discretion to the appropriate regulatory authority in the intended
drug market.
Why drug master file is required?
The Main Objective of the DMF is to support regulatory requirements and to prove the
quality, safety and efficacy of the medicinal product for obtaining an Investigational New
Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug
Application (ANDA), another DMF, or an Export Application.
What is the difference between DMF and CEP?
Being a European certificate, the CEP is granted by the EDQM but is recognized by other
countries/institutes such as the FDA in the US. Furthermore, just like the DMF, the data
as submitted in the CEP is handled strictly confidential and provides a centralized system
recognized by many countries.
Is DMF required for excipients?
An Excipient DMF is not required by law or FDA regulations. It is submitted solely at
the discretion of the holder. It is not approved or disapproved. The DMF contains
manufacturing and controls information and technical data to support the safety and
quality of the excipient.
What are the types of DMF?
Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer
applicable).
Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their
Preparation, or Drug Product.
Type III: Packaging Material
Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V: FDA Accepted Reference Information
Drug Master File (DMF) contains confidential and factual information about facilities,
processes (includes drug product chemistry, manufacture, stability, purity, impurity
profile etc.) or articles used in the manufacturing, processing, packaging, and storing of
one or more human drugs. DMF helps the manufacturer to keep relevant information
secret and at the same time to sell the product to different customers using this drug
within there final application.
The information contained in the DMF may be used to support an Investigational New
Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug
Application (ANDA).
A DMF is NOT a substitute for an IND, NDA, ANDA, or Export Application. It is not
approved or disapproved. Technical contents of a DMF are reviewed only in connection
with the review of an IND, NDA, ANDA, or an Export Application.
DMF contains complete information on an Active Pharmaceutical Ingredient (API) or
finished drug dosage form. In Europe it is known as European Drug Master File (EDMF)
or Active Substance Master File (ASMF) and in US it is known as US-Drug Master file
(US-DMF).
Note:EDMF is the old name of Active Substance Master File (ASMF)
DMF’s are mostly prepared following the rules of Common Technical Documentation
(CTD).
Prerequisites
Production process is well established and fixed in writing (Master production
instructions).
Specifications of raw materials as well as of the final product are defined
including specification of packaging material.
Inprocess controls, sampling points and procedures are clearly outlined.
Critical process steps are validated, equipment is qualified.
Analytical methods are validated.
Impurity profile is established.
Stability program is set up and first data are available.
Basic GMP requirements are fullfilled.
Data required for the CTD are
General Information
Nomenclature
Structure Description
General Properties
Manufacture
Manufacturer(s)
Description of manufacturing process and process controls
Control of materials
Controls of critical steps and intermediates
Process validation and/or evaluation
Manufacturing process development.
Characterisation
Elucidation of structure and other characteristics
Impurities
Control of drug substance
Specification
Analytical Procedures
Validation of analytical procedures
Batch analyses
Justification of Specification
Reference Standards or Materials
Container Closure System
Stability
