Drug Master File (DMF) is a package of confidential, proprietary assets, specifying the formula, processes, materials, test methods, and other information relevant to the manufacture of product used in the composition, packaging, and/or processing of pharmaceuticals and/or biologics.
Types of DMFs
Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel
Type II: Drug substance and drug product should be separate. For drug substance, type II DMF may be submitted in the format for “Drug Substance” in the “Guidance for Industry M4Q the CTD Quality.
Type III: Confidential detailed packaging material information in support of an application i.e. IND, NDA, ANDA and BLA. A letter of authorization (LOA) is required.
Type IV: Contains information regarding excipients, colors, flavors, essences or anything used in preparation of any of these.
Type V: Requires clearance from the FDA prior to submission. If any holder needs to submit information in a DMF that is not covered by Types I through IV.
Parts of DMF
The DMF is divided into two parts:
Applicant’s part (Open part)
Information regarded as to be non-confidential and to be given to the applicant. This information is also given to the authority as part of DMF services. These parts include: General information, Characterization, Control of API, Reference standards or materials, Container closure system & Stability.
Restricted part (Closed part):
Information regarded as to be confidential and to be submitted only to the Authority. These parts include: Manufacture, Manufacturer(s)/site of manufacture, Detailed description of the manufacturing process and process controls, Control of materials (Starting material of the API, reagents, solvents, other materials used), Control of critical steps and intermediates, Process validation and/or evaluation & Manufacturing process development.
Contents of DMF
1 General information
1.1 Nomenclature
1.2 Structure
1.3 General properties
2 Manufacture
2.1 Manufacturer(s)
2.2 Description of Manufacturing Process and Process controls
2.3 Control of Materials
2.4 Control of critical steps and intermediates
2.5 Process validation and/or Evaluation
2.6 Manufacturing Process Development
3 Characterisation
3.1 Elucidation of Structure and other Characteristics
3.2 Impurities
4 Control of Drug Substance
4.1 Specification
4.2 Analytical procedures
4.3 Validation of analytical procedures
4.4 Batch analysis
4.5 Justification of Specification
5 Reference standards or materials
6 Container Closure System
7 Stability
7.1 Stability summary and conclusion
7.2 Post-approval Stability Protocol and Stability Commitment
7.3 Stability data
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