About gempex

About gempex

About gempexCore Team

Ralf Gengenbach

Mr. Ralf Gengenbach as Managing Director, founded gempex GmbH in 2002. Today the company is one of the leading GMP service providers with an international orientation. With more than 35 years of work experience in the GMP-regulated industry, Mr. Ralf is deeply involved in the multi-field technology of life science and GMP regulatory, such as biotechnology, sterile products, chemicals, and APIs. Mr. Ralf is currently in full charge of the management of gempex's global consulting projects.

In 1987,he graduated from the University of Karlsruhe (TU Karlsruhe) with a master's degree in chemical engineering.

From 1987 to 1997, he was responsible for cGMP compliance of biological and chemical APIs as Engineer at BASF Headquarters (Ludwigshafen). During which time, Mr. Ralf was the Chairman of the BASF GMP Committee.

From 1997 to 2002, he worked in DIS AG, Mannheim. He set up and managed of the “GMP-Consulting” division.

In 2002, gempex was founded in Mannheim, Germany by Ralf Gengenbach.

Currently, Mr. Ralf is the Chairman of the ECA Validation Group, Member of the International Society of Pharmaceutical Engineering (ISPE) and Chairman of the German Pharmaceutical Association VIP3000.

As a senior GMP consultant, Mr. Ralf Gengenbach participated in the discussion and formulation of several regulations and industry technical standards, such as the international standard PIC/S PI006 (validation) and ICH Q7 GMP guidelines. At the same time, he has also written and published dozens of technical articles and published more than 400 pages of the book《GMP - Qualification and Validation of API Facilities: A Practical Guide》, interpreting regulations in simple terms and providing a lot of practical guidance, contributing to the development of the industry.