Saturday, 24 March 2018

Pharmeuropa Volume 30 No 1, January 2018

Certificate of suitability of Monographs of the European Pharmacopoeia (CEP).

A manufacturer of a substance can provide proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia by a CEP granted by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM). The CEP confirms that pharmaceutical substances or active pharmaceutical ingredients (API) are produced according to the monographs of the EP. The CEP bridges between European Pharmacopoeia monographs and the need to prepare a file for licensing and thus it also bridges between industry and health authorities.

Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.1 before 31 March 2018.


Posted by Dr. Tim Sandle

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