The application forms for the submission of new Certificate of Suitability applications and for requests for revision or renewal have been slightly revised in order to remove the reference to the EDQM Dropbox and submission of CD-ROM/DVD.
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 last monthly activity report for the Certification of Substances Division (DCEP) is now available.
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.
Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment.
The EDQM is proud to announce that its Quality Management System has been recognised compliant to the 2015 version of the ISO 9001 standard.
Webinar on Elemental Impurities 17 January 2017: registration is closed as the maximum number of participants has been reached.
EDQM has published the document « API-Mix (or mixtures) and CEPs » with regards to the acceptance of applications for CEPs where the associated monograph of the European Pharmacopoeia is for a mixture of an API and excipient.
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).
Good Practice Guidelines published in the “Guide to the Preparation, Use and Quality Assurance of Blood Components” will become mandatory within the 31 Member States of the European Union and the European Economic Area from 15 February 2018
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.