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Certification of suitability (CEP) | News | 03 February 2016 | Strasbourg, France
Within the framework of the 3rd meeting of the International Generic Drug Regulators Programme (IGDRP) in Strasbourg, the EDQM is pleased to organise a one-day workshop on the IGDRP initiative on Friday, 13 May 2016, when industry representatives and other stakeholders will have the opportunity to interact directly with regulators from around the world.
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Certification of suitability (CEP) / Procedure of certification (general) | News | 02 February 2016 | Strasbourg, France
The last monthly activity report for the Certification of Substances Division (DCEP) is now available for January 2016.
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Certification of suitability (CEP) / Procedure of certification (general) | News | 01 February 2016 | Strasbourg, France
A review of the pricing policy for the activities associated with the procedure for Certificates of suitability to the monographs ...
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EDQM / Quality Management system | News | 09 December 2015 | Strasbourg, France
The EDQM is proud to announce that after a comprehensive three-day certification audit, the French certification body AFNOR (AFAQ), decided in December 2015 to renew its ISO 9001 certificate granted to the EDQM.
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Certification of suitability (CEP) / API | News | 12 November 2015 | Strasbourg, France
The overall objective of the meeting was to strengthen international co-operation and share experiences in the field of API inspections.
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Certification of suitability (CEP) / Procedure of certification (general) | News | 21 October 2015 | Strasbourg, France
A new document is now available which provides clarification on the processing of complaints arising from the implementation of the CEP procedure and its related inspection programme.
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Certification of suitability (CEP) / CEP new application | News | 13 October 2015 | Strasbourg, France
Applicants and Holders of certificates of suitability (CEP) are responsible for maintaining the details of the contact person up-to-date for their applications, to ensure timely and efficient communication with EDQM. The document “Changes in contact details to be notified to EDQM” (PA/PH/CEP 10 (86) 1R) has been revised...
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Certification of suitability (CEP) / Procedure of certification (general) | News | 09 October 2015 | Strasbourg, France
The EDQM has established its roadmap for the submission of CEP applications in electronic format for the next 4 years. Since this Roadmap represents a major change to current practices, the EDQM would like to gather comments from stakeholders on the actions and timelines, and if necessary review the plans before implementing them.
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EDQM | News | 23 September 2015 | Strasbourg, France
EDQM website has gotten a new look with a mobile-friendly design The EDQM has redesigned its website using Responsive Web Design techniques, which means the look of the EDQM website will...
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Certification of suitability (CEP) / Certification content of dossier | News | 09 September 2015 | Strasbourg, France
The EDQM has revised the guideline “Content of the Dossier for Chemical Purity and Microbiological Quality”.
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Certification of suitability (CEP) / Procedure of certification (general) | News | 02 September 2015 | Strasbourg, France
The EDQM would like to remind holders of certificates of suitability (CEP) and their customers about the policy to be applied...
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European Pharmacopoeia / General | News | 01 June 2015 | Strasbourg, France
The EDQM has just published its 2014 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. In her foreword, EDQM Director, Dr Susanne Keitel, comments on the year’s events, achievements, and thanks all involved for their dedication, expertise and support.
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