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Consideration should be given to API mixtures and CEP Procedure

Certificate of Suitability (CEP) granted by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM) confirms that pharmaceutical substances or active pharmaceutical ingredients (API) are produced according to the monographs of the EP. The CEP bridges gap between European Pharmacopoeia monographs and the need to prepare a file for licensing and thus it also bridges between industry and health authorities.

However, in some cases, it is necessary to produce APIs not in pure form, but as a mixture. Major reason for this approach is easier manageability or API stability. Few examples are: Chlorhexidine digluconate in aqueous solution, a clavulanate potassium auxiliary mixture or simvastatin blended with an antioxidant.

In April 2016, EMA published a Q and A explaining how the API mixes are required to be handled in CEP procedure during an authorisation.

A "Public Document" called "API-Mix (or mixtures) and CEPs" (PA/PH/CEP (16) 70) was released in December 2016. This document describes the procedure of applying for a certificate of suitability for API mixtures. An application for a CEP for an API mix should contain the following information:

A CEP for an API mix contains the following information (unless already contained in the pharmacopoeial monograph):

Therefore, a CEP is generally granted for an API mix if the excipient used is listed in the monograph and labeling. In the absence of required information regarding qualitative and quantitative composition, of excipients the application for a CEP will be refused.


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