active substance master file definition
active substance master file means a document that contains a detailed description of the manufacturing process, quality control during manufacture and process validation prepared in a separate document by the manufacturer of the active substance;
active substance master file or "ASMF" shall mean the drug master file formerly known as European Drug Master File (EDMF) as specified in the European Medicines Agency's Guideline on Active Substance Master File Procedure, and in Annex I to Directive 2001/83/EC as amended Part I, 3.2 Basic principles and requirements, (8) Active Substance Master File (for Human medicinal products).