In the manufacture of (bio) pharmaceuticals and medical devices, the cleaning and control of microbiological contamination are critical areas. Therefore, the disinfectants used, the frequency of their use and the rotation of (one or more) disinfectants together with a sporicidal agent should be scientifically justified by a formal microbiological risk assessment (MRA). Please read more here

The term "biopharmaceuticals" comprises a very heterogeneous group of products - ranging from monoclonal antibodies, hormones, enzymes, plasma products and ATMPs to biosimilars. This results in several new challenges for manufacturers as well as for authorities to ensure the required safety and quality of the products in accordance with Directive 2001/83/EC. So what do the authorities expect? Please read more here

WannaCry, Petya, GoldenEye ... for some years now malware has been threatening the IT infrastructure of companies worldwide. The latest attacks have already caused major damages - even at some global players. The fact that they had only a "limited" impact and did not completely paralyse entire companies was due to a few "design failures". The question is, therefore, whether the IT infrastructure has to be reconsidered to face the growing IT threats? Please read more here

Last December, the webinar GMP Update summarized the latest "innovations" and "changes" in the GMP environment. In part II of this article, you will find out more about the developments in clinical trials, water for injection purposes, process validation for biotechnological products, ATMPs or data integrity in the current year. Please read more here