The Drug Master File (DMF) is a valuable repository of confidential information which can be stored at the FDA by a product manufacturer in the pharmaceutical industry. The DMF summarizes the essential elements pertaining to facilities, processing, manufacturing components, packaging and storage for products associated with pharmaceutical product development. FDA guidance documents are available to assist with development of the DMF components, but translating the FDA regulations and guidance documents into actual practices reflecting current product development can be challenging. Expertise and diligence are required to determine which documents need to be created, stored and updated over time in the DMF at the FDA for support of marketing applications made by others using the company product.
This course will review two FDA websites and the three FDA guidances pertaining to DMFs
- Drug Master Files (DMFs)
- 21 CFR Part 314 Applications for FDA approval to market a new drug, Subpart G- Miscellaneous Provisions, Section 314.420 Drug master files
- Drug Master Files: Guidelines
- Guidance for Industry: Drug Master Files for Bulk Antibiotic Drug Substances
- Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research
Attendees will learn the differences between the five types of DMFs and the detailed information required within each type of DMF. Using a series of case studies, the course will highlight real word examples and actual experiences with FDA submissions related to DMF components. Upon completion of the course, attendees will be able to begin developing or to improve upon their DMF file documentation.
- Understand the two FDA websites and three FDA guidance documents regarding DMFs.
- Drug Master Files (DMFs).
- 21 CFR Part 314 Applications for FDA approval to market a new drug, Subpart G- Miscellaneous Provisions, Section 314.420 Drug master files.
- Drug Master Files: Guidelines.
- Guidance for Industry: Drug Master Files for Bulk Antibiotic Drug Substances.
- Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research.
- Review the five types of DMFs and their uses.
- Able to develop the information to be contained in the DMF.
- Understand when the DMF should be filed with the FDA.
- Be able to describe experiences of others regarding real world issues associated with creating and submitting DMFs.
- Able to use a checklist to construct a DMF from scratch.
Who will benefit:
- Regulatory Affairs
- Research and Development
- Quality Assurance & Control
- Development and Preparation of Submission Materials