ABSTRACT
DRUG MASTER FILES AND CERTIFICATES OF SUITABILITY TO MONOGRAPHS OF THE EUROPEAN PHARMACOPOEIA As already mentioned in chapter 8: Drug Substance-General Information, in cases where the full details ofmanufacture of the drug substance cannot be included inModule 3.2.S of the Common Technical Document (CTD) registration file, the regulatory agencies have devised other means of submitting and reviewing the documentation to protect valuable and commercially confidential “know-how” on the details of manufacturing process for the drug substance. Two key methods are the Drug Master File (called an Active Substance Master File in the European Union) and Certificates of Suitability to theMonograph of the European Pharmacopoeia (CEPs) for pharmacopoeial monograph drug substances. The CEP is used in the European Union, Australia, and Canada.
