Join us and celebrate the 20 years anniversary of ECA in Heidelberg at the 8th European GMP Conference - Meet speakers from US FDA, EU GMP Inspectorates and Pharmaceutical Industry to hear the latest GMP Trends - Receive the latest ECA Guidance Documents at no costs!
From 9-10 April 2019 in Düsseldorf, Germany - More than 60 Speakers from pharmaceutical companies and GMP Inspectorates - Case Studies from Novartis, Roche, Boehringer Ingelheim, Sanofi, Bayer, Pfizer and many more - 3 GMP/FDA Conferences – create your own agenda!
With news, trainings and conferences, a comprehensive guidelines database, publications and more the ECA is the leading European training and information services provider in the GMP and GDP environment.
In February 2019, the WHO published a new Guideline for comment on the production of WFI using non-distillation methods. Read more about the draft entitled "Production of Water for Injection by Means other than Distillation".
Will it be necessary to transfer information about the unique identifier uploaded to the UK repository between 9 February 2019 and the Brexit date to another repository? EMA recently published the answer to this and other related questions.
Data from pre-clinical/clinical studies are often not sufficient for a comprehensive qualification of impurities with regard to their biological safety profile. The new EMA Reflection Paper provides guidance for determining the safety profile of impurities by means of various methods.
The FDA strengthens the process for issuing a public warning about a voluntary recall and for notification of recalls. Read more about FDA´s final guidance on Public Warning and Notification of Recalls.