With the implementation of the ICH Q3D guideline on elemental impurities, the control of elemental impurities is undergoing a shift in paradigm, moving away from pure substance-based testing towards a holistic control strategy in the finished product.
The EDQM is pleased to announce that the 2016 issue of Pharmeuropa Bio & Scientific Notes is available online
The Ph. Eur. Commission unanimously decided to grant Japan observer status. This brings to 30 the number of observers, from 6 continents.
The chapter on Chemical Imaging (5.24) was adopted by the European Pharmacopoeia Commission at the end of November 2016.
The EDQM is proud to announce that its Quality Management System has been recognised compliant to the 2015 version of the ISO 9001 standard.
Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment.
The P4Bio pilot phase came to a successful conclusion at the 156th Session of the European Pharmacopoeia Commission, with the adoption of the monograph for Etanercept (2895).
During its 156th Session, the Ph.Eur. Commission unanimously decided to grant India observer status. This brings to 29 the number of observers, from 6 continents.
At its 156th Session the European Pharmacopoeia Commission adopted the monograph on Sodium pertechnetate (99mTc) (accelerator-produced) injection (2891).
The recent adoption at its 156th session on 22-24 November of new texts demonstrates the Commission’s commitment to the replacement, reduction and refinement of animal tests in the quality control of medicines.
At its 156th session (22-23 November 2016), the European Pharmacopoeia Commission approved the priorities for the three coming years, which are aimed at maintaining the scientific excellence, leading role and influence of the Ph. Eur. worldwide.
The meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), and the United States Pharmacopeia (USP)] was hosted by JP in Tokyo, Japan, 24-26 October 2016.
Top representatives from the EDQM, the Chinese Pharmacopoeia Commission (ChP) and major trade associations gathered recently in Strasbourg for a one-day workshop
In three texts published in Edition 9.0, certain of the mathematical symbols ‘>’ and ‘<’ were missing from all versions (print, online and USB) of the English text...
The EDQM’s international conference held in Tallinn to mark the publication of the 9th edition of the European Pharmacopoeia (Ph. Eur.) brought together participants from 41 different countries.