Newsroom Certification of suitability
Do you intend to apply for a Certificate of Suitability (CEP) for a sterile substance? A guideline for the preparation of dossiers to obtain a CEP for a sterile substance is now available
The European Directorate for the Quality of Medicines & HealthCare (EDQM) wishes to provide further guidance to applicants for the preparation of their dossiers to obtain a Certificate of Suitability (CEP) for a sterile substance. This document clarifies the conditions for acceptability of this...
Certification monthly report of activities: End of October 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of October 2024 Certification Monthly Report For more information, access the Certification Database.
CEP Revisions Teamleader
Do you have proven experience in the evaluation or the preparation of documentation on the quality of substances for pharmaceutical use?
Removal of expiry notifications from the EDQM DCEP Sharing Tool
The EDQM DCEP Sharing Tool is used to share EDQM documents securely between the Certification of Substances Department (DCEP) and CEP holders or applicants. Users receive an e mail with a link when a document is shared with them. Links expire after 60 days, after which time the documents cannot...
Implementation of the European Pharmacopoeia Supplement 11.7 – Notification for CEP holders
Supplement 11.7 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 April 2025, and to follow the...
CEP holders invited to comment on draft monographs published in Pharmeuropa 36.4
Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 36.4. The table below lists the substances...
Certification monthly report of activities: End of September 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of September 2024 Certification Monthly Report For more information, access the Certification Database.
Save the date: Webinar Everything you've always wanted to know about the certification (CEP) procedure.
The EDQM invites CEP holders and users to participate in a webinar to facilitate the understanding of the Certification Procedure on 21 November 2024. Programme overview: The EDQM invites CEP holders and users to participate in a webinar to ask any kind of questions on the Certification Procedure...
Certification monthly report of activities: End of August 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of August 2024 Certification Monthly Report For more information, access the Certification Database.
Certification monthly report of activities: End of July 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of July 2024 Certification Monthly Report For more information, access the Certification Database.
Making a significant difference – 2023 EDQM annual report published in new engaging digital format
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published its 2023 annual report. For the first time, the report is completely digital, with a new, intuitive design and interactive features, facilitating your discovery journey and making it...
CEP holders invited to comment on draft monographs published in Pharmeuropa 36.3
Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 36.3. The table below lists the substances...
Certification monthly report of activities: End of June 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of June 2024 Certification Monthly Report For more information, access the Certification Database.
Implementation of the European Pharmacopoeia Supplement 11.6 – Notification for CEP holders
Supplement 11.6 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 January 2025, and to follow the...
Certification monthly report of activities: End of May 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of May 2024 Certification Monthly Report For more information, access the Certification Database.
Certification monthly report of activities: End of April 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of April 2024 Certification Monthly Report For more information, access the Certification Database.
How to identify the manufacturing sites linked to CEP application (revised document)?
Please consult the revised policy document which has been updated to complete the identification of the manufacturing sites by the SPOR OMS coordinates. The use of these coordinates is mandatory, and companies should ensure that their organisation name and location address(es) given to the EDQM...
CEP holders invited to comment on draft monographs published in Pharmeuropa 36.2
Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 36.2. The table below lists the substances...
Certification monthly report of activities: End of March 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of March 2024 Certification Monthly Report For more information, access the Certification Database.
As a CEP applicant, you want to improve the quality of your dossier? The revised EDQM guideline “content of the dossier” and other key documents will be useful tools
The revised version of the EDQM guideline “Content of the dossier for chemical purity and microbiological quality of substances for pharmaceutical use” is now available and will be implemented as of 1 May 2024. This guideline and other key documents (QOS, top ten deficiencies), as well as the use...