CEPs are Becoming More Transparent!

The quality of a pharmaceutical API can be described in two ways: either through the Active Substance Master File (ASMF) procedure, or, if the API is covered in a monograph, through the CEP procedure. The CEP (Certificate of Suitability) confirms that the API has been manufactured in compliance with the monograph of the European Pharmacopoeia.

A release recently published by the EDQM states that starting on 15 July 2013 all revised or newly issued CEPs will comprise detailed information on operations involved in the manufacture and testing of the API — as, for exmple, facilities in which intermediates were manufactured or in which milling or sterilization steps were conducted. The CEP will also list quality control labs and facilities for in-process controls. For CEPs issued before 15 July 2013 the manufacturers are asked to forward this information to their customers.

The background for this extension of CEPs are the regulations of the recently revised EU "Guideline on Active Substance Master File Procedure"; CHMP/QWP/227/02 Rev 3/Corr", which requires exactly this detailed information for the ASMF (see GMP News from 19 June 2013). To ensure the CEP procedure's consistency with the ASMF procedure the EDQM has taken over these requirements. They are by the way only applicable to CEPs describing the API's purity. CEPs on TSE are not affected.