Karl Metzger is Managing Partner & CEO  at gmPlan GmbH with his focus on GMP auditing, consulting & training. He is an APIC-certified ICH Q7 Auditor with more than twenty years experience in global auditing.

Karl Metzger graduated in Chemistry (Dipl. Chem.) from the University Kaiserslautern, Germany in 1989. After several years in biochemical research and analytical development, he joined BASF Pharma in 1995 as GMP/DMF Coordinator in the Uetersen site. From 1997 to 2001 he worked as project manager in the areas GMP Training & GMP consulting: first for Concept Heidelberg with his focus on API and Documentation, second with TDH/Euro Engineering and his focus on Qualification/Validation of API & excipient plants.

He worked for Welding GmbH & Co. KG in Hamburg from 2001 to 2010. There he was Management Representative for Welding's integrated Management System (covering GMP, HACCP, ISO and SHE requirements), Head of Production, and Deputy QP for APIs.

Furthermore Karl Metzger was active in several national and international federations (e.g. in the Good Trade and Distribution Committee of FECC, the European Association of Chemical Distributors.)

From copy &paste to the risk-based approach-Twenty years GMP experience in China: comments from a Western perspective

This presentation will give you an impression how Chinese GMP compliance is assessed abroad. The lecturer is a GMP expert working since more than twenty years on the interface: on one side he supports western pharmaceutical companies to recruit Chinese suppliers on the other side he tries to convince Chinese manufacturers to follow the suitable GMP rules.

During this period of a time he became witness of China's development from a source of intermediates and substances which nobody in the Western hemisphere, wanted to produce anymore, due to the massive impact on the environment, to a supplier of the whole range of pharmaceutical products and services from large volume substances to sophisticated medicinal products. Whereas twenty years ago it seemed as 'The Art of War' is the most important rulebook for the market players, nowadays the global GMP regulations are widely acknowledged and implemented.

Finally there will be a view on modern GMP - the establishment of a scientifically sound 'risk-based approach' focusing on the two key aspects of GMP: avoidance of contamination and maintenance of traceability. Leading to the final question: When you are ill, do you rather take the medicine from your company or will you prefer the one from another market player?