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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