A Drug Master File (DMF) is confidential detailed information about materials, facilities, processes, specifications, container-closure system and stability used in the manufacturing, processing, packaging, and storing of one or more human drugs.
Types of DMF’s
- Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
Each DMF submission should contain –
- A transmittal letter,
- Administrative information about the submission, and
- The specific information to be included in the DMF as described in this section.
- The DMF must be in the English language. Whenever a submission contains information in another language, an accurate certified English translation must also be included.
- Each page of each copy of the DMF should be dated and consecutively numbered. An updated table of contents should be included with each submission.
Content of atypical API DMF
1. General Information
- Nomenclature of the API
- Structure of the API
- General Properties of the API
2. Manufacture
- Manufacturer details
- Description of manufacturing process and process controls
3. Characterization
- Elucidation of structure and other characteristics
- Impurities
4. Control of drug substance
- Specification
- Analytical Procedures
- Validation of analytical procedures
- Batch analyses
- Justification of Specification
5. Reference Standards or Materials
6. Container Closure System
7. Stability
- Stability Summary and Conclusion
- Post Approval and Stability Commitment
- Stability Data
As per FDA guideline, the submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. 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).
Reference: FDA Drug Master Files: Guidelines
USFDA Drug Master File Template:
https://www.fda.gov/drugs/drug-master-files-dmfs/drug-master-file-dmf-templates
