What is a CEP & how does it work?

It links the Ph. Eur. monograph to the API itself. The manufacturer of the API submits a CEP as part of the market authorization process, and they will become the CEP holder of the document. Being a European certificate, the CEP is granted by the EDQM but is recognized by other countries or institutes, such as the FDA in the US.

What does CEP mean in EDQM?

… What does ‘CEP’ mean? EDQM FAQs / EDQM FAQs in English / CERTIFICATION OF SUBSTANCES FOR PHARMACEUTICAL USE / General information on Substances for pharmaceutical use / General and scope / What does ‘CEP’ mean? ‘CEP’ stands for ‘Certification of suitability to the monographs of the European Pharmacopoeia’.

What is a sister CEP?

A sister CEP is, ideally, approved on a fast track basis compared to the timelines of the original CEP applications. A set of pre-defined conditions are set by EDQM that must be fulfilled in order to file a Sister CEP. Reaching out to an expert with information on sister CEP will help in quick approvals of the application.

What is an example of a CEP use case?

An in-depth BPM guide A good example of a CEP use case of this type is an enterprise software vendor with a large, important customer coming up for renewal. The customer is experiencing a service disruption that no one but the customer service department is aware of -- putting the renewal at risk.