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. Expertise and diligence are required to determine which documents need to be created, stored and updated over time in the DMF at the FDA. This course will give an overview of the two FDA websites, different types of DMFs and detailed information required within each type of DMF.
The one and a half day seminar will focus on the two FDA websites and following three FDA guidance documents regarding DMFs:
• 21 CFR Part 314 Applications for FDA approval to market a new drug, Subpart G- Miscellaneous Provisions, Section 314.420 Drug master files.
• 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• Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research.
The instructor will also discuss on
• The five types of DMFs and their uses.
• Developing the information to be contained in the DMF.
• When the DMF should be filed with the FDA.
• Real world issues associated with creating and submitting DMFs.
• Creating a checklist.
• Relationship between DMFs and current Good Manufacturing Practices.
Who will benefit
The course will be beneficial to the regulatory personnel involved in:
• Regulatory Affairs
• Research and Development
• Quality Assurance & Control
• Development and Preparation of Submission Materials
Added by complianceonlinecom on November 20, 2012