Explore the EDQM’s Certification Policy Documents and Guidelines to access essential resources for the Certification of Suitability (CEP) procedure. This section provides up-to-date regulatory guidance, technical advice, and operational documents to support pharmaceutical ingredients manufacturers and stakeholders in preparing their CEP applications.

Operational documents

These documents are related to the practical aspects of the Certification procedure (management of documents, fees, maintenance of CEP, administrative information)

Governance documents

These documents describe the background and the legal framework of the Certification Procedure. They clarify its mission and organisation.

How to build a good CEP application

These documents (including applications forms) are available for CEP holders and applicants to assist them in preparing a high-quality dossier and addressing guidance to be followed for specific technical points.

Content of a dossier

Specific guidance

Application forms

Electronic submissions

These documents describe the tools and format to be used for electronic submissions for CEP applications.

Inspection programme

These documents could be used to prepare for an inspection and to better understand the inspection programme.