DMF in Pharmaceutical Industry
What is a DMF?
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
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.
Types of DMFs:
- Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel
- 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
Contents of a DMF:
- Company information
- Facility information
- Process information
- Material information
- Quality control and assurance information
- Regulatory compliance information
Purpose of a DMF:
- Provide confidential information to the FDA
- Support regulatory submissions (e.g., NDAs, ANDAs)
- Facilitate inspections and audits
- Demonstrate compliance with FDA regulations
Drug Master File Sample
A well-prepared DMF sample can serve as a valuable reference for new submissions. It typically includes sections on:
- General Information: Description of the manufacturing site, facilities, and equipment.
- Manufacturing Process and Controls: Detailed processes and controls for the drug substance or product.
- Characterization: Data supporting the characterization of the drug substance or product.
- Stability: Stability data to support the shelf life of the drug substance or product.
Read also:
- Site Master File in Pharmaceutical Industry
- Audits and Inspections in Pharmaceutical Industries
- Common Pitfalls in CMC Dossier Authoring
Resource Person: Vikas Bedi
