Drug Master File packaging

Packaging/labeling DMF (drug master file) Applicable law/arbitration... 

Drug Master Files (DMF). DMF is a submission to the 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. 

Drug Master File (DMF) completed, including information on facilities, processes, and articles used in manufacturing, processing, packaging, and... 

The selection of an inert package is an essential part of the pharmaceutical development of a drug. There are many standard stoppers, plastic and glass bottles, and so on with which regulatory authorities are very familiar and for which drug master files are already in place. Stability studies must be conducted, of course, in the same sorts of packaging. 

Much more detailed information on the package is required by the FDA than is generally required in the EU, but the data may be submitted in the form of a drug master file, which allows container or resin manufacturers to supply the FDA directly with detailed confidential data. 

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