Newsroom Certification of suitability
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...
How CEP holders can avoid the rejection of notifications
In order to facilitate the acceptance of proposed changes in a timely manner, CEP holders are reminded that the European Directorate for the Quality of Medicines & HealthCare (EDQM) Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia...
The template of Quality Overall Summary (QOS) to be submitted for Certification applications has been adapted to the current needs!
A new version of the QOS template is now available. It may be used from January 2024 and will become mandatory as of April 2024. The QOS (eCTD Module 2) has to be provided along with an initial submission since it is essential in the review of a new CEP application. This updated template gives...
Certification monthly report of activities: End of February 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of February 2024 Certification Monthly Report For more information, access the Certification Database.
Save the date: webinar on CEP 2.0
The EDQM invites CEP holders and users to participate in a public webinar on the 9th April 2024 to share their experiences on the use of CEP 2.0. More info at: https://www.edqm.eu/en/cep-2-0-fresh-feedback-from-stakeholders
Certification monthly report of activities: End of January 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of January 2024 Certification Monthly Report For more information, access the Certification Database.
Read the top 10 deficiencies observed in new CEP applications for chemical purity assessed in 2023 to improve the quality of your applications!
This document is a summary of the top ten deficiencies identified after the initial evaluation of new applications for Certificates of Suitability (CEP) for chemical purity. The content of this document is intended to help applicants to build their application in conjunction with the EDQM...
EDQM’s ISO 9001:2015 certification maintained
The European Directorate for the Quality of Medicines & HealthCare’s (EDQM) ISO 9001:2015 certificate has been maintained following the second surveillance audit of its quality management system on 28 and 29 November 2023 by the official French standardisation body Association française de...