Ralf Gengenbach

Dipl.-Chem.-Ing. Ralf Gengenbach started his professional career in 1987 at BASF AG, Ludwigshafen, after his university study as a chemical engineer at the Technical University (TU) Karlsruhe. For around 10 years he acted as an internal Good Manufacturing Practice (GMP) consultant. Besides establishing an efficient and cost-oriented qualification system, he also was active in numerous technical committees and associations on this topic, among others for the German Institute for Standardization (DIN), the German Chemical Industry Association (VCI), and the Society for Chemical Engineering and Biotechnology (DECHEMA). He was early involved in the preparation and commentary of the “Pharmaceutical Inspection Co-operation Scheme” (PIC/S) document PI006 (validation) and the Q7-GMP guideline of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). After another professional interlude, he founded 2002 the gempex GmbH, an international GMP service providing company, which he still is managing today. In addition to numerous publications, lectures, and talks, he has summarized his accumulated knowledge among others in the book “GMP, Qualification, and Validation of Active Pharmaceutical Ingredient Facilities” published by Wiley-VCH.