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Drug Master File (US DMF)
Drug master file submission to US FDA with all information required for an NDA is the responsibility of the drug manufacturer; however, in many cases, information on materials used in the production or packaging of the drug product, such as the formulation of a packaging material, is considered by the supplier to be confidential trade secret information. Consequently, the US Drug Master File (US DMF) system was developed to permit suppliers to make this information on their products directly available to US FDA for its review of drug company applications that involve the use of the supplier’s material. www.i3cglobal.com
Types of Drug Master FileThe US Drug Master File (US DMF) is submitted to US FDA for review of its contents. Totally there are five types of drug master file (US DMF):
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
Each US Drug Master File (US DMF) should contain only one type of information and all supporting data.
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