Supplement 9.3 of the Ph. Eur. is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of January 2018, and to follow the instructions given
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 29.3 before 30 September 2017.
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Do not miss this opportunity to expand your knowledge and familiarise yourself with the the Procedure of Certification of Suitability to the monographs of the European Pharmacopoeia (CEP).
The EDQM has just published its 2016 Annual Report. The report is an opportunity to review the different activities of the past year and reflect on what the EDQM accomplished and developed.
EDQM has published the document « Top ten deficiencies – New Applications for Certificates of Suitability for chemical purity (2015-2016) ».
The EDQM will hold an international conference on 19-20 September 2017 in Prague (Czech Republic) to trace recent changes to the Certification Procedure in a fast moving regulatory environment.
The document PA/PH/CEP (13) 110 which described the policy for assessment of CEP applications has been revised following a review of current practice.
The application forms for the submission of new Certificate of Suitability applications and for requests for revision or renewal have been slightly revised...
The EDQM is proud to announce that its Quality Management System has been recognised compliant to the 2015 version of the ISO 9001 standard.
EDQM has published the document « API-Mix (or mixtures) and CEPs » with regards to the acceptance of applications for CEPs where the associated monograph of the European Pharmacopoeia is for a mixture of an API and excipient.