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Certification of suitability (CEP) / Procedure of certification (general) | News | 22 October 2020 | Strasbourg, France
The EDQM is launching a project to design the CEP of the future. The consultation will remain open until 31 December 2020 in the form of an online survey.
Certification of suitability (CEP) / Procedure of certification (general) | News | 12 October 2020 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Certification of suitability (CEP) | News | 03 September 2020 | Strasbourg, France
The EDQM has concluded its investigation following reports that paracetamol manufactured by a specific company holding a certificate of suitability could be contaminated with the impurity 4-chloroaniline (PCA).
EDQM / All activities | News | 17 August 2020 | Strasbourg, France
The EDQM’s core activities include the provision of documentary and physical (reference) standards to ensure the quality of medicines and their ingredients. Availability of and access for patients to quality medicines is more important than ever in the context of the current COVID-19 pandemic.
Certification of suitability (CEP) / Nitrosamines | News | 17 August 2020 | Strasbourg, France
In October 2019, the EDQM requested companies holding CEPs to perform a risk assessment of their chemically synthesised APIs with regard to potential nitrosamine formation, using quality risk management principles. It was highlighted that the factors to be taken into account were outlined in the dedicated Questions and Answers documents available on the EMA and CMDh websites.
Certification of suitability (CEP) / Procedure of certification (general) | News | 23 July 2020 | Strasbourg, France
Supplement 10.3 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 2021, and to follow the instructions given in the document.
Certification of suitability (CEP) / CEP revision | News | 21 July 2020 | Strasbourg, France
Following experience gained since the introduction of the revised EDQM Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2, 7R corr) in January 2019, this announcement is intended to clarify a couple of items.
Certification of suitability (CEP) / Procedure of certification (general) | Certificate of suitability (CEP) | 16 July 2020 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 32.3 before 30 September 2020.
Certification of suitability (CEP) / API | News | 10 July 2020 | Strasbourg, France
Following the publication of an article in the Dutch newspaper Nieuwe Rotterdamsche Courant Handelsblad (NRC) concerning an impurity (4-chloroaniline) in the active substance paracetamol manufactured by a specific company which holds a certificate of suitability, the EDQM is actively working with the company and other stakeholders to better understand the potential impact of this impurity and the...
EDQM / All activities | News | 30 June 2020 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare’s 2019 annual report is now available, providing a comprehensive overview of our activities in 2019 and information on our achievements and events.
Certification of suitability (CEP) | News | 23 June 2020 | Strasbourg, France
Would you like to build a career in regulatory affairs? Do you have excellent chemical synthesis or analytical chemistry skills? Do you have the scientific expertise required to check the acceptability of applications for Certification of Suitability to the monographs of the European Pharmacopoeia (CEP) on receipt, to critically review data according to ICH, EU and EDQM guidelines, to prepare...