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THE PHARMA REVIEW (NOVEMBER - DECEMBER 2010)

Global Drug Master Filing Procedures

S. K. Sahu2, P. K. Nandi2, B. Suresh1, M. A. Azam1,

Abstracts

DMF (Drug Master File) is a submission to the agency containing information regarding facilities, processes or articles used in the manufacturing, processing, packaging and storing of human drugs. The DMF is usually filed by a manufacturer of the drug substance, drug substance intermediates, excipients and packaging materials. The filing of DMF helps the regulatory agencies to assess the quality of the raw materials and packaging materials used in the manufacturing of the finished dosage form independently. In USA and Canada the Drug Master Files are classified into 5 types and 4 types, respectively, whereas in Europe and Australia, the Drug Master Files are only of 1 type, which is used for the drug substance and drug substance intermediates.

Introduction
DMF is a submission to the agency containing information regarding facilities, processes or articles used in the manufacturing, processing, packaging and storing of human drugs and it exists only in the highly regulated markets like USA, Canada, Europe and Australia.

 

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