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Certification of suitability (CEP) | News | 23 February 2017 | Prague, Czech Republic
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.
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Certification of suitability (CEP) | News | 13 February 2017 | Strasbourg, France
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.
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Certification of suitability (CEP) / Procedure of certification (general) | News | 09 February 2017 | Strasbourg, France
The last monthly activity report for the Certification of Substances Division (DCEP) is now available.
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Certification of suitability (CEP) | News | 20 January 2017 | Strasbourg, France
The application forms for the submission of new Certificate of Suitability applications and for requests for revision or renewal have been slightly revised...
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EDQM / Quality Management system | News | 05 January 2017 | Strasbourg, France
The EDQM is proud to announce that its Quality Management System has been recognised compliant to the 2015 version of the ISO 9001 standard.
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Certification of suitability (CEP) | News | 14 December 2016 | Strasbourg, France
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.
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Certification of suitability (CEP) / Procedure of certification (general) | News | 21 November 2016 | Strasbourg, France
The EDQM has revised the document "Guidance for electronic submissions for Certificates of Suitability (CEPs) applications".
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Certification of suitability (CEP) / Procedure of certification (general) | News | 08 November 2016 | Strasbourg, France
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.
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Certification of suitability (CEP) / Procedure of certification (general) | News | 26 September 2016 | Strasbourg, France
EDQM has revised the policy regarding the use of a CEP to describe a material in an application for another CEP.
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News | 01 September 2016 | Strasbourg, France
The guideline ICH M7 on “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” has been adopted...
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Certification of suitability (CEP) | News | 04 August 2016 | Strasbourg, France
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).
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Certification of suitability (CEP) / Procedure of certification (general) | News | 03 July 2016 | Strasbourg, France
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).
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