Certifying the quality of an API
What is a CEP?
A Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) certifies that the quality of an active pharmaceutical ingredient (API) can be suitably controlled by the European Pharmacopoeia monograph, with additional tests dependant on the method of synthesis. The role of the CEP is to certify the compliance of a material with the requirements laid down in the relevant monograph. CEP’s were established in 1994 for pharmaceutical substances, and later for herbal drugs, and products with risk of TSE. CEP’s are recognised by the signatory parties of the convention on the elaboration of a European Pharmacopoeia i.e. all member states and the European Union. They are also recognised by other countries e.g. Canada, Australia, New Zealand, Tunisia and Morocco.