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Certification of suitability (CEP) / Procedure of certification (general) | News | 14 December 2018 | Strasbourg, France
Following introduction of the revised Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopeia Monographs’ (PA/PH/CEP (04) 2, 7R corr) several EDQM policy documents have been revised and are available.
Certification of suitability (CEP) / Chemical purity | News | 14 December 2018 | Strasbourg, France
The revised EDQM guideline Content of the dossier for chemical purity and microbiological quality, PA/PH/CEP (04) 1, 6R will enter into force in January 2019.
Certification of suitability (CEP) / Procedure of certification (general) | News | 11 December 2018 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Certification of suitability (CEP) / Procedure of certification (general) | News | 20 November 2018 | Strasbourg, France
The revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs’ (PA/PH/CEP (04) 2 7R) will enter into force in January 2019. Notable changes include the classification of changes related to the introduction of a new manufacturer of a starting material (see page 7), explicit reference to recent changes in the regulatory...
Certification of suitability (CEP) / CEP suspension | News | 19 November 2018 | Strasbourg, France
Following new information recently received by EDQM about the detection of low levels of N-nitrosodiethylamine (NDEA) in Valsartan manufactured by MYLAN LABORATORIES Ltd , the EDQM has immediately suspended the certificate of suitability (CEP) R1-CEP 2009-396-Rev 03/Valsartan held by this company, until appropriate corrective actions are taken.
Certification of suitability (CEP) / Procedure of certification (general) | News | 09 October 2018 | Strasbourg, France
Supplement 9.7 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 1 April 2019, and to follow the instructions given in the document.
Certification of suitability (CEP) / Procedure of certification (general) | News | 04 October 2018 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.4 before 31st December 2018.
Products and Services | News | 27 September 2018 | Strasbourg, France
The 9.7 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 April 2019.
European network of OMCLs | News | 14 September 2018 | Strasbourg, France
The EDQM continues investigating and defining actions to address the presence of all kinds of nitrosamines, including NDMA and NDEA in valsartan and other sartans which may be affected. As mentioned in a previous press release, the EDQM has contacted those manufacturers holding CEPs (Certificates of Suitability to the monographs of the European Pharmacopoeia) and whose substances may present a...
Certification of suitability (CEP) | News | 28 August 2018 | Strasbourg, France
The EDQM is continuing the investigations and actions which started in July 2018 to address the issue related to the detection of N-nitrosodimethylamine (NDMA) in a source of active substance valsartan.
Certification of suitability (CEP) / API | News | 27 July 2018 | Strasbourg, France
The EDQM is aware of a quality defect related to an impurity in the active substance valsartan used in medicines to treat high blood pressure marketed in Europe.
Certification of suitability (CEP) / Procedure of certification (general) | Guideline | 17 July 2018 | Strasbourg, France
The EDQM document “Implementation of ICH Q3D in the Certification Procedure” has been revised based on experience gained by EDQM since the initial implementation of the policy. Its implementation date is the 1st September 2018.
EDQM / All activities | Report | 02 July 2018 | Strasbourg, France
The EDQM has released its 2017 Annual Report providing an overview of its accomplishments. Among the major highlights for the past year, the European Pharmacopoeia (Ph. Eur.) Commission kept on ensuring that the monographs and texts of the Ph.Eur. stay abreast of scientific and technological progress and achieved considerable progress in the field of biotherapeutic products. For example, the...
EDQM | News | 12 June 2018 | Metz, France
The first stone of a new secondary site for the Council of Europe’s European Directorate for the Quality of Medicines and HealthCare (EDQM) has been laid. The new site will be used to store the EDQM’s portfolio of over 3 000 pharmaceutical reference standards, as an addition to those already in stock at the main building in Strasbourg.
Certification of suitability (CEP) | News | 22 May 2018 | Strasbourg, France
EDQM has elaborated the guideline “How to read a CEP” with the aim of describing in detail the information conveyed on the Certificates of suitability to the Monographs of the European Pharmacopoeia (CEP).