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Answer of the following question. What are the different types of DMFs (Drug Master Files)?

Question:

Answer of the following question. What are the different types of DMFs (Drug Master Files)?

Drug Master Files (DMF):

A DMF is a compilation of paperwork that is submitted to the United States Food and Drug Administration by a manufacturer of a pharmaceutical. It contains detailed information about the production facilities, manufacturing processes, and components used in the formulation, processing, packaging, and storage of the drug.

Answer and Explanation:

In the United States, there are 5 types of DMFs:

Type Description
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

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Pharmaceutical Drugs: Definition & Types

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Chapter 1 / Lesson 2
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