DMF is short for drug master file,it is a document prepared by a pharmaceutical manufacturer.The document includes the factory equipment and monitoring data of producing,packaging and storing.
The DMF document has five types,Type 1 is Manufacturing Site, Facilities, Operating Procedures, and Personnel;Type 2 is Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product;Type 3 is Packaging Material;Type 4 is Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation;Type 5 is FDA Accepted Reference Information.
So if the drug manufacturer want to export USA,the pharmaceutical manufacturer need apply for Type 2，The application document need include application form,relative administrative information,corporate commitment statements, physical and chemical descriptions of product applications, detailed product manufacturing methods, product quality control and production process control, product stability testing, packaging and labeling, standard operating procedures,storage and management of raw materials and finished products, document management, verification, batch number management system, returns and processing.So the drug manufacturer need find a medicine packaging factory which has DMF registration number.
The original DMF file was first reviewed by FDA. If it meets the basic requirements of the relevant regulations, FDA will issue a notification letter and issue it with a DMF registration number.
