The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
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.
The EDQM has revised the document "Guidance for electronic submissions for Certificates of Suitability (CEPs) applications".
The EDQM roadmap for electronic submissions for CEP applications has been revised in order to align with the recently established HMA (Heads of Medicines Agencies) eSubmission Roadmap.
EDQM has revised the policy regarding the use of a CEP to describe a material in an application for another CEP.
The guideline ICH M7 on “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” has been adopted...
A document has been prepared to provide guidance on the implementation of ICH Q3D on elemental impurities in the context of Certificates of Suitability (CEP).
The EDQM is preparing its next international conference on its Certification Procedure, which will take place in 2017 (final date and European venue to be confirmed in the coming weeks).