What is CEP?

CEP stands for “Certificate of Suitability to the Monographs of the European Pharmacopoeia” (CEP). It is a certification issued by the European Directorate for the Quality of Medicines (EDQM). The purpose of a CEP is to demonstrate that a substance complies with the requirements of the relevant monograph of the European Pharmacopoeia, which ensures its suitability for use in pharmaceutical products. This certification is particularly important for substances used in the manufacture of pharmaceuticals, such as active pharmaceutical ingredients (APIs) or excipients.

A CEP is often required when a pharmaceutical company includes a substance in a drug product and needs to demonstrate its compliance with European Pharmacopoeia standards. It simplifies the regulatory approval process by providing evidence that the substance meets the required quality standards without the need for additional testing by regulatory authorities.