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Prepare DMF

There are four types of Drug Master Files (DMFs) available now:


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


The DMF should be provided in the Electronic Common Technical Document—Quality format (eCTD). The Common Technical Document is divided into five modules:


Module 1: Administrative and prescribing information

Module 2: Overview and summary of modules 3 to 5

Module 3: Quality (pharmaceutical documentation)

Module 4: Preclinical (Pharmacology/Toxicology)

Dodule 5: Clinical – efficacy and safety (Clinical Trials)


For example, the Module 3 in USA DMF should include the following contents:

3.1. Table of contents of Module 3

3.2. Body of data

3.2.S Drug substance

3.2.S.1 General Information

3.2.S.1.1 Nomenclature

3.2.S.1.2 Structure

3.2.S.1.3 General Properties

3.2.S.2 Manufacture

3.2.S.2.1 Manufacturer(s)

3.2.S.2.2 Description of Manufacturing Process and Process Controls

3.2.S.2.3 Control of Materials

3.2.S.2.4 Controls of Critical Steps and Intermediates

3.2.S.2.5 Process Validation and/or Evaluation

3.2.S.2.6 Manufacturing Process Development

3.2.S.3 Characterisation

3.2.S.3.1 Elucidation of Structure and other Characteristics

3.2.S.3.2 Impurities

3.2.S.4 Control of Drug Substance

3.2.S.4.1 Specification

3.2.S.4.2 Analytical Procedures

3.2.S.4.3 Validation of Analytical Procedures

3.2.S.4.4 Batch Analyses

3.2.S.4.5 Justification of Specification

3.2.S.5 Reference Standards or Materials

3.2.S.6 Container Closure System

3.2.S.7 Stability

3.2.S.7.1 Stability Summary and Conclusions

3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment

3.2.S.7.3 Stability Data

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