Get Drug Master File Pdf

Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form.

“The drug master file is required to contain a complete list of each person currently authorized to incorporate by reference any information in the file, identifying by name, reference number, volume, and page number the information that each person is authorized to incorporate.”

FDA: DMFs help ensure the safety and efficacy of the drug or biologic products under review. Because the information contained in DMFs is confidential, DMFs provide FDA with a source of detailed data for FDA's safety and efficacy review and the use of DMF expedites FDA's timely review of Applications.

There are four types of master files: Type II: Drug substance, drug substance intermediates, and material used in their preparation, or drug product. Type III: Packaging material. Type IV: Excipients, colorant, flavor, essence, or material used in their preparation.

INTRODUCTION. A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

What is the difference between DMF and dossier? Drug Master File (DMF) is part of 3.2. S (Drug substance) of the dossier which contains information regarding API only, whereas the dossier is the collection of detailed documents containing information about a particular drug product for submission to a Regulatory body.

Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They: Allow parties to reference material without disclosing DMF contents to those parties.

Where to Submit an MAF. An MAF and all amendments should be submitted to the appropriate Center's Document Control Center (DCC). The current mailing address for CDRH's DCC and a link to CBER's DCC's mailing address are provided on the eCopy Program for Medical Device Submissions webpage.