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Certification of suitability (CEP) / CEP new application | News | 26 November 2021 | Strasbourg, France
On 1 October 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) commenced the use of a new IT tool to manage CEP applications. The implementation of this tool requires that timelines for evaluation of all CEP applications and their revisions/renewal be specified in working days instead of calendar days, which will also provide greater clarity on deadlines for...
EDQM / Quality Management system | News | 15 November 2021 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) Laboratory successfully obtained the renewal of its accreditation according to the ISO/IEC 17025:2017 standard in October 2021 from the Belgian accreditation organisation BELAC, confirming the validity of the results generated for its European Pharmacopoeia reference standards. The accreditation scope covers 21...
European Pharmacopoeia / Monograph | News | 15 November 2021 | Strasbourg, France
After almost two years of online events, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is eager to announce the organisation of an international conference to celebrate the publication of the 11th Edition of the European Pharmacopoeia (Ph. Eur.). This in-person event will be held from 19 to 21 September 2022, in Strasbourg (France), if the pandemic situation allows...
Products and Services | News | 10 November 2021 | Strasbourg, France
To check whether orders for publications or reference standards can be shipped in 2021, users are invited to consult the EDQM order reception deadlines for December.
European Pharmacopoeia / International harmonisation | News | 08 November 2021 | Strasbourg, France
The harmonised general chapter Chromatography was signed-off by the Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), on 28 September 2021. The coordinating pharmacopoeia for this text was the Ph. Eur.
Transfusion | News | 05 November 2021 | Strasbourg, France
Human plasma is the critical component of numerous therapeutic products used in the treatment of life-threatening diseases, including bleeding or immune system disorders and other severe pathologies. In recent years, the global use of and demand for plasma for fractionation have grown and it is a well-known fact that Europe is not self-sufficient in this regard and relies on imported plasma from...
Reference Standard / Collection & Catalogue | News | 04 November 2021 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) announces the availability of 5 new European Pharmacopoeia (Ph. Eur.) reference standards and 19 replacement batches for Ph. Eur. reference standards, released in October 2021.
Reference Standard / Collection & Catalogue | News | 29 October 2021 | Strasbourg, France
Are you rigorous and work-orientated? Do you have a technical qualification in logistics and professional experience relevant to the profile? Do you wish to acquire valuable experience in the distribution of pharmaceutical reference standards and samples? We are looking for someone like you to contribute directly to providing the quality of service expected by the EDQM’s users.
Certification of suitability (CEP) | News | 27 October 2021 | 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...
Certification of suitability (CEP) | News | 20 October 2021 | Strasbourg, France
Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.4. The table below lists the substances affected by these revisions and for which a CEP has been granted.
Certification of suitability (CEP) | News | 19 October 2021 | Strasbourg, France
Supplement 10.7 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 April 2022, and to follow the instructions given below.
European Pharmacopoeia / International harmonisation | News | 18 October 2021 | Strasbourg, France
The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), with the World Health Organization (WHO) as an observer, is preparing a pilot to integrate additional world pharmacopoeias. This is a critical step in the PDG’s commitment to expanding recognition of harmonised...
European Pharmacopoeia / General | News | 15 October 2021 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) will discontinue the device version of the European Pharmacopoeia (Ph. Eur.) as of the 11th Edition, which is scheduled for publication in July 2022, and focus efforts on the online and paper versions.
European Pharmacopoeia / Monograph | News | 14 October 2021 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter on Osmolality (2.2.35), published in this quarter’s issue of Pharmeuropa (33.4) for comment (deadline 31 December 2021).
Transfusion | News | 14 October 2021 | Strasbourg, France
The supply of blood components involves a series of complex processes composed of numerous steps, each carrying intrinsic and extrinsic risks. Blood establishments must continuously adapt to new regulatory and technical requirements in quality management as part of their risk avoidance strategy. In this evolving context, quality risk management can play a pivotal role in meeting these...