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European Pharmacopoeia / General | News | 14 January 2019 | Strasbourg, France
Monographs and general texts on radiopharmaceutical preparations are elaborated by experts in the field. In order to guide experts on the information to be included in European Pharmacopoeia (Ph. Eur.) monographs, and also to harmonise the style of the different monographs, a Guide for the elaboration of monographs on radiopharmaceuticals was published by the EDQM in 2010.
European Pharmacopoeia / Ph. Eur. Commission | News | 14 January 2019 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission has decided to replace the Histamine Sensitisation Test “HIST” (test in mice) with a standardised CHO cell clustering assay (in vitro cell-based test) for residual pertussis toxin testing in acellular pertussis vaccines, as of next year. The introduction of a standardised CHO cell-clustering assay for residual pertussis toxin testing is based on...
European Pharmacopoeia / Public enquiry | News | 09 January 2019 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on a new general chapter, 2.6.32. Test for bacterial endotoxins using recombinant factor C (rFC). This is not a new topic for the Ph. Eur. which was one of the first pharmacopoeias to refer to rFC, namely in chapter 5.1.10 Guidelines for using the test for bacterial endotoxins in Supplement 8.8 (2016), allowing the...
European Pharmacopoeia / Animal testing | News | 06 December 2018 | Strasbourg, France
The EDQM has welcomed the recommendation of the WHO Expert Committee on Biological Standardization (ECBS) to omit the abnormal toxicity test (also called the innocuity test) in all future WHO documents on vaccines and other biological products, and to disregard the inclusion of this test in previously published WHO Technical Report Series documents.
European Pharmacopoeia / Ph. Eur. Commission | News | 30 November 2018 | Strasbourg, France
At its 162nd Session in Strasbourg on 20-21 November 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts and 128 revised texts. All of the adopted texts help ensure that the Ph. Eur. remains up to date and in line with the latest regulatory developments and scientific state of the art; they will be effective from 1 January 2020 and will be published in 10th Edition of...
European Pharmacopoeia / General text/chapter | News | 28 November 2018 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission decided to restructure Section 3. of the Ph. Eur. on materials and containers. A new Subsection 3.3. has been added to Section 3. in order to cover specific medical devices: containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.
Reference Standard / General | News | 16 November 2018 | Strasbourg, France
The expertise of the EDQM laboratory has recently been confirmed by an ISO 17025 accreditation for Nuclear Magnetic Resonance spectroscopy (NMR) and quantitative Nuclear Magnetic Resonance spectroscopy (qNMR). These modern and state of the art techniques further expand the technical competence of the EDQM laboratory to characterise the official reference standards of the European Pharmacopoeia (...
European Pharmacopoeia / Public enquiry | News | 06 November 2018 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on Ph. Eur. dosage form monograph on Parenteral preparations (0520) and new informative chapter on testing for visible particles (5.17.2)
European Pharmacopoeia / Public enquiry | News | 30 October 2018 | Strasbourg, France
Your input is essential to shape future European Pharmacopoeia (Ph. Eur.) monographs and helps keep texts relevant and fit for purpose. The issue 30.4 of Pharmeuropa is complete and ready for comments: manufacturers and users have until 31 December 2018 to provide their feedback on draft Ph. Eur. texts and to verify their products’ compliance with the new or revised drafts monographs.
European Pharmacopoeia / General text/chapter | News | 30 October 2018 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its new general chapter 5.1.12 on depyrogenation of items used in the production of parenteral preparations. While depyrogenation is not a new topic for the Ph. Eur., this is the first time that a dedicated chapter covers specifically the inactivation of pyrogens and related endotoxin indicators. Pyrogens are substances...
European Pharmacopoeia / Pharmacopoeial discussion group (PDG) | News | 24 October 2018 | Strasbourg, France
The face-to-face meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP)] was hosted by the EDQM in Strasbourg, France, on 2-3 October 2018. WHO participated as Observer.