14/15 April 2021
If you submit an application for a certificate of suitability (CEP) for an active substance to the EDQM, your dossier has to comprise extensive information on the quality of the active substance, its synthesis as well as on the used starting materials and intermediates. The document providing the specifications for this purpose, dates back to the year 2007 and is titled "content of the dossier for chemical purity and microbiological quality" (PA/PH/CEP (04) 1, 4R).) It says in the chapter "control of materials (3.2.S.2.3)":
"In the case of a route of synthesis consisting of one or only a few steps, full details of the manufacture of the starting material(s) should be given and/or at least detailed specifications especially regarding the impurity profile including residual solvents and catalysts. Alternatively, for starting materials described in the European Pharmacopoeia certificates of suitability can be provided, if available."
So CEPs for raw materials can be used to apply for an API CEP which eliminates the need for the detailed description of the starting material in such an application. But what are the exact conditions and requirements for such a procedure? A new EDQM document entitled "Use of a CEP to describe a starting material in on application for another CEP" (PA/PH/CEP (14) 06) provides some information. According to this document it is possible to use a starting material CEP in the application process under the following conditions:
Following further provisions in relation to the life cycle of the material or its CEP have to be noted:
In general detailed information has to be provided about all production sites involved in the manufacturing process for the raw material.