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European network of OMCLs | News | 21 December 2021 | Strasbourg, France
Upon conclusion of a Biological Standardisation Programme (BSP) study, the outcome is made available in Pharmeuropa Bio & Scientific Notes providing readers with useful information regarding the method(s) used and, where appropriate, the value assignment of the established reference standard.
News | 15 December 2021 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Supplement 10.8 is now available and will be applicable in 39 European countries as of 1 July 2022.
Certification of suitability (CEP) | News | 14 December 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
News | 10 December 2021 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has updated its order confirmations to make them easier to read, including clearly identifying: the estimated shipping date for each product; any information the EDQM needs from you in order to ship your order; if your order will to be split into different shipments (this will depend on the availability and the...
European Pharmacopoeia / Ph. Eur. Commission | News | 06 December 2021 | Strasbourg, France
The 171st session of the European Pharmacopoeia (Ph. Eur.) Commission took place on 23 and 24 November 2021. At this session, the Commission adopted 75 texts for publication in the 11th Edition of the European Pharmacopoeia.
Reference Standard / Collection & Catalogue | News | 03 December 2021 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) announces the availability of 13 replacement batches for European Pharmacopoeia reference standards, released in November 2021.
European network of OMCLs / Active pharmaceutical ingredient (API) | News | 02 December 2021 | Strasbourg, France
The Active Pharmaceutical Ingredient (API) Working Group of the General European OMCL Network (GEON) has conducted a market surveillance study on omeprazole, the results of which have been published in the Journal of Pharmaceutical and Biomedical Analysis, Vol. 208 (2021).
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...
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...
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...
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.