Thomas Zimmer, PhD, is ISPE Vice President, European Operations. He previously was Senior Vice President of the Corporate Division, Safety, Quality & Environmental Protection at Boehringer Ingelheim, where he worked from 1981 to 2000 and held several positions in pharmaceutical development and pharmaceutical manufacturing and in the area of management operations for the Americas and Europe. He was also Head of the Project Production Alli-ance Europe and later Head of Pharma Operations at Boehringer Ingelheim France. Thomas is Chair of the Anti-Counterfeiting Ad Hoc Group and a mem-ber of the Scientific, Technical and Regulatory Policy Committee at the European Federation of Pharmaceutical Industries and Associations. He is Chair of the Industry Advisory Board for the Institute for Packaging of the University of Applied Sciences in Berlin, a member of ISPE’s International Leadership Forum, and a board member of the Pharmaceutical Security Institute. He studied pharmacy at the Johann Wolfgang Goethe University in Frankfurt/Main, where he wrote his doctoral thesis in pharmaceutical technology.
This article presents the work of the newly formed ISPE Holistic Production Control Strategy Working Group, which has identified and summarized the need for a redefined control strategy implementation methodology.