Authors: T. Appel, D. Diedrich, S. Eberhardt, B. Früh, M. Kamer, S. Krüger, M. Schick-Leisten, E. Schmidt, T. Schwibbe, K. Wiese
E-mail: qualitaet@dgsv-ev.de
Introduction
In Germany, validation of reprocessing processes has been an established practice for several years now. When process validation was first introduced there was a certain anxiety prior to testing but any such concerns have now been allayed thanks to the recommendations published on this topic by the German Society of Sterile Supply (DGSV). These recommendations are now being updated to take account of new knowledge, legal provisions and normative amendments.
Download the recommendation here: AKQ_en_ZT_4_16