“Japan Quality” in Pharmaceutical Technical Operations Part I: Understanding differences in quality expectations between Western and Japanese markets Hirokazu Sugiyama, Lars Sukowski, Rainer Schmidt F. Hoffmann-La Roche Ltd., Pharma Technical Operations Biologics, Sterile Drug Product Manufacturing, Kaiseraugst, Switzerland Corresponding author: Hirokazu Sugiyama, PhD, F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, 4070 Basel (Switzerland), e-mail: hirokazu.sugiyama@roche.com In this two-part article, “Japan Quality” in pharmaceutical products and their manufacturing processes are explored. Part I focuses on general cultural aspects in order to identify and understand the critical differences between Japanese and Western expectations of quality. Part II will show how Western manufacturers can overcome these differences, based on a case study: the ongoing initiative of continuous improvement being implemented in the new Roche Parenterals production facility in Kaiseraugst, Switzerland. By pinpointing “what needs to be known” and determining “how best to respond”, the authors aim to provide Western manufacturers with a blueprint for achieving “Japan Quality”. Key words Cosmetic defects • Cultural difference • Japan Quality • Pharmaceutical manufacturing • Visual inspection |
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pharmind 2011, Nr. 4, Seite 754
