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Certification of suitability (CEP) / CEP revision | News | 19 May 2021 | Strasbourg, France
The EDQM document “Implementation of policy on elemental impurities in the Certification Procedure” has been revised to reflect that risk assessments have to be performed and suitable controls for elemental impurities should be implemented using the principles of risk management for substances for veterinary use.
Food contact materials and articles | News | 19 May 2021 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the first edition of the technical guide entitled “Paper and board used in food contact materials and articles”, following the October 2020 adoption of the resolution on the safety and quality of materials and articles for contact with food by the Committee of Ministers of the Council of Europe.
Transfusion | News | 18 May 2021 | Strasbourg, France
The EDQM will be participating in the 31st regional congress of the International Society of Blood Transfusion (ISBT) – “ISBT in Focus!” – which will take place online from 2 to 8 June 2021. Come and visit the EDQM’s virtual stand and find out more about our organisation and its activities related to blood transfusion.
European Pharmacopoeia / Biological standardisation programme (BSP) | News | 18 May 2021 | Strasbourg, France
A new article on the successful outcome of the study for the establishment of European Pharmacopoeia Pertussis Toxin Biological Reference Preparation (BRP) batch 2 has been published in Pharmeuropa Bio & Scientific Notes.
European Pharmacopoeia | News | 11 May 2021 | Strasbourg, France
The revised general monograph Water for injections (0169) has been published in this quarter’s issue of Pharmeuropa (33.2), the European Pharmacopeia (Ph. Eur.) online forum, for comment. The text has been revised to delete the tests for inorganic substances from the section on Sterilised water for injection.
European Pharmacopoeia / Ph. Eur. Commission | News | 10 May 2021 | Strasbourg, France
At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of chapter 1. General Notices.
News | 06 May 2021 | Strasbourg, France
The EDQM announces the availability of: 7 new European Pharmacopoeia (Ph. Eur.) reference standards and 26 replacement batches for Ph. Eur. reference standards.
Certification of suitability (CEP) / Procedure of certification (general) | News | 06 May 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
News | 05 May 2021 | Strasbourg, France
In January 2019, the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Commission (EC) organised the International Symposium on Plasma Supply Management. This event – the first of its kind – brought together stakeholders in the blood sector to discuss the increasing use of plasma for fractionation. Participants addressed the matter of increasing the...
News | 04 May 2021 | Strasbourg, France
When the experimental results allow, draft monographs will be published in Pharmeuropa with a peak area repeatability requirement of RSD ≤ 1.0% (n=6) determined on a solution containing the active substance CRS.
News | 03 May 2021 | Strasbourg, France
The IMWP monographs on Favipiravir and on Favipiravir tablets are an outcome of the pharmacopoeial alert system, which was established in 2019 at the 9th International Meeting of World Pharmacopoeias (IMWP) in Da Nang, Vietnam to ensure pharmacopoeias work together in any relevant public health crisis. An alert under this system was triggered in response to the COVID-19 pandemic to contribute to...
European Pharmacopoeia | News | 03 May 2021 | Strasbourg, France
At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission approved a new policy for the development of monographs on medicinal products containing chemically defined API salts and/or API (base/acid).
News | 29 April 2021 | Strasbourg, France
Following recent investigations demonstrating the mutagenicity of an azido impurity in sartan active substances (APIs) with a tetrazole ring, the EDQM confirms that the CEP holders concerned have already been contacted and have addressed the issue as requested.
European Pharmacopoeia / Monograph | News | 29 April 2021 | Strasbourg, France
The 2022 subscriptions to the European Pharmacopoeia (Ph. Eur.) are now available for sale on the EDQM WebStore.
News | 23 April 2021 | Strasbourg, France
The new Official Control Authority Batch Release (OCABR) Guideline for Pandemic COVID-19 Vaccine (Recombinant Spike Protein), containing the agreed list of tests to be performed by Official Medicines Control Laboratories (OMCLs) for OCABR, is now available and is in force from 20 April 2021.