The DMF filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details. 1.4.3 - List of authorized persons to incorporate by reference This list should be submitted in DMF annual reports.
Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. Section 1.12.14 Environmental Analysis: See Environmental Assessment The language in the following sentence in the DMF Guidance, Section VII.
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Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. However, the document provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. b) Specification and routine tests of the Raw Materials. An Agent Appointment Letter is NOT an LOA and should not be called “Letter of Authorization” and should not be submitted in Section 1.4.1 1.4.2 - Statement of Right of Reference Submission by recipient of a Letter of Authorization with a copy of the LOA and statement of right of reference.
Typically, a drug master file is filed when two or more firms work in partnership on developing or manufacturing a drug product. Description of Manufacturing Process and Process Control a) Flow Chart of Manufacturing Process b) Synthetic Route of Manufacturing Process c) Manufacturing Method. Submitted in a DMF only when another DMF is referenced.