Newsroom Certification of suitability
EDQM ISO 9001:2015 certification renewed
The European Directorate for the Quality of Medicines & HealthCare (EDQM) successfully obtained the renewal of its certification according to the ISO 9001:2015 standard from the AFNOR certification body, confirming the compliance of the Quality Management System of the EDQM with this standard....
Certification monthly report of activities: End of May 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of May Certification Monthly Report For more information, access the Certification Database.
Register now for our upcoming training programme on the Ph. Eur., reference standards and CEPs
8 independent modules – 8 topics – 8 Q&A sessions – All LIVE! This 100% virtual training will focus on chemically defined active substances and cover all the fundamentals related to the use of the European Pharmacopoeia and its reference standards, as well as the procedure for Certification of...
Certification monthly report of activities: End of April 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of April 2022 Certification Monthly Report For more information, access the Certification Database.
EDQM sticker no longer to appear on Certificates of suitability
As of the 1 May 2022, the European Directorate for the Quality of Medicines & HealthCare (EDQM) sticker will no longer appear on Certificates of suitability to the European Pharmacopoeia monographs (CEPs). This adhesive sticker (see picture) will no longer be pasted on CEPs next to the wet...
Certification monthly report of activities: End of March 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of March 2022 Certification Monthly Report For more information, access the Certification Database.
CEP holders invited to comment on draft monographs published in Pharmeuropa 34.2
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 34.2. The table below lists the substances...
Certification monthly report of activities: End of February 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of February 2021 Certification Monthly Report For more information, access the Certification Database.
Update of application forms for Certificate of Suitability applications
The forms for the submission of Certificate of Suitability to the European Pharmacopoeia monographs (CEP) applications (new applications, revisions and sister files) have been updated in order to facilitate their handling and the transfer of the collected data in the new IT tools implemented at...
EDQM remote inspections: from pilot phase to a permanent element of EDQM’s inspection scheme!
In March 2020 travel restrictions, designed to minimise the spread of SARS-CoV-2, interrupted the inspection programme of the European Directorate for the Quality of Medicines & HealthCare (EDQM), which monitors compliance with both Good Manufacturing Practice (GMP) and applications for...
Certification monthly report of activities: End of January 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. January 2022 Certification Monthly Report For more information, access the Certification Database.
EDQM reminds CEP holders of their responsibilities towards their customers
CEP holders have obligations towards the marketing authorisation holders in order to enable them to fulfil their respective legal responsibilities. Recent issues have demonstrated the lack of knowledge of some CEP holders regarding those obligations. In order to clarify the issue, EDQM has...
How to use the EDQM DCEP sharing tool
The EDQM DCEP sharing tool is a new IT tool used to ensure the secure sharing of EDQM documents between the EDQM Certification of Substances Department (DCEP) and CEP holders or applicants during the CEP lifecycle. Specific instructions are given to the intended users for the creation and the...
Implementation of the European Pharmacopoeia Supplement 10.8 – Notification for CEP holders
Supplement 10.8 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 July 2022, and to follow the...
CEP holders invited to comment on draft monographs published in Pharmeuropa 34.1
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 34.1. The table below lists the substances...
Certification monthly report of activities: End of December 2021
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. December 2021 Certification Monthly Report For more information, access the Certification Database.
“CEP of the future”: project update
The consultation phase of the project to design the Certificate of suitability to the monographs of the European Pharmacopoeia (CEP) of the future has been completed. The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the survey outcome and a roadmap for...
Certification monthly report of activities: October & November 2021
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. October & November 2021 Certification Monthly Report For more information, access the Certification Database.
Change in EDQM timelines for CEP applications
On 1 October 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) commenced the use of a new IT tool to manage CEP applications. The implementation of this tool requires that timelines for evaluation of all CEP applications and their revisions/renewal be specified in...
CEP holders invited to comment on draft monographs published in Pharmeuropa 33.4
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 33.4. The table below lists the substances...
Collaboration, Innovation and Scientific Excellence: the European Pharmacopoeia 11th Edition