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.
What are FDA's plans concerning new guidelines for calendar year 2019? The Center for Drug Evaluation and Research (CDER) has provided an answer to that question in its list of planned guidelines and/or guidelines to be revised.
The most common method of preventing microbiological contamination in a water system is thermal sanitisation. There are systems in which the pharmaceutical water is stored hot and systems that are heated cyclically to an elevated, germicidal temperature. However, excessive temperatures not only increase costs, they can also damage the materials. Read more here.
Within the framework of risk analysis, qualification and preparation of sampling plans for new purified water (PW) systems, the question arises as to whether PW should be tested for endotoxins. Read more here.