Regulatory
CEP (certificate of suitability)
Definition
A certificate from the EDQM confirming that an API's quality is suitably controlled by the European Pharmacopoeia monograph.
The certificate of suitability to the monographs of the European Pharmacopoeia is issued by the EDQM after assessing the manufacturer's dossier, and sometimes after an inspection. Medicine makers in Europe and in many other countries that accept CEPs can use it in their marketing authorisation instead of submitting the full API data.
When a supplier claims to hold a CEP, ask for the certificate number and check it in the EDQM's public certification database.
Related terms
- EP grade (European Pharmacopoeia)Material that meets the European Pharmacopoeia (Ph. Eur.) monograph, legally binding in its member states.
- DMF (Drug Master File)A confidential file submitted to the US FDA with detailed information on how an API, excipient or packaging is made and controlled.
- GMP (good manufacturing practice)Rules for making medicines, APIs, food and cosmetics so that every batch is consistently produced and controlled to its quality standard.