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  • Review of Drug Master File (DMF)

    A drug master file (DMF) is a submission to Food and Drug Administration (FDA) and is a kind of confidential document which contains detailed information about the facilities, processes, manufacturing, processing, packaging, and storing of human drug products. In DMF the details mentioned may be used to support an (IND) Investigational New Drug Application,( NDA) New Drug Application, or (ANDA) Abbreviated New Drug Application.

    DMFs and their types:

    DMFs are submitted by the pharmaceutical companies which manufacture drug Substances, Intermediates that generally contain the chemistry, facilities, process technology for manufacturing processes, quality controls either of drug substance, excipient or packaging material, etc. DMF submission is not essentially required by law or as per the regulation of the FDA and is submitted by the choice of the holder. FDA allows parties to reference the material without disclosing DMF contents to those parties and reviews the technical contents of DMFs in connection with the review of applications that reference them e.g., NDAs, ANDAs, and INDs. This guideline discusses the types of DMFs and the information required in each type which includes the format of submissions to a DMF, the administrative procedures, and other requirements.

     Types of DMFs:

    TYPESInformation provided in the DMF
    Type IManufacturing Site, Facilities, Operating procedures, and personnel
    Type IIDrug Substance, Drug Substance Intermediate, and Material Used in their Preparation; or Drug Product
    Type IIIPackaging Material
    Type IVExcipient, Colorant, Flavor, Essence, or Material used in their Preparation
    Type VFDA Accepted Reference Information
    • Type I: This type of DMF is for Manufacturing sites, Facilities, Operating Procedures, and Personnel. This DMF is discontinued but the numbering of the other DMF types has not changed.
    • Type II: The most common type of DMF Type II in general, is limited to a single drug intermediate, drug substance, drug product, or type of material used in their preparation. Type II summarizes all important steps involved in the manufacturing and controls of the drug intermediate or substance. 
    • Type III: This Type III DMF contains information on Packaging Material, each packaging material should be identified by the intended use, components, composition, and controls for its release.
    • Type IV: This type of DMF corresponds to Excipient, Colorant, Flavor, Essence, or Material used in their Preparation. The additives to be identified and characterized by their method of manufacture, testing methods, and release specifications. Toxicological data need to be included on these materials under this type of DMF.
    • Type V: Type V DMF contains FDA Accepted Reference Information, FDA discourages the use of Type V DMFs for miscellaneous information, duplicate information, or information that should be incorporated in one of the other types of DMFs.


    • Drug master file guidance for detailed information:

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