“Japan Quality” in Pharmaceutical Technical Operations Part II: Building a blueprint for better performance in the Japanese market 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 Part II of this paper presents a blueprint of how Western pharmaceutical companies can improve their performance in the Japanese market. It begins by discussing the three pillars of this strategy: product customization, continuous process improvement, and awareness-raising in communication. Then the focus is narrowed onto drug product manufacturing, with particular reference to continuous improvement activities initiated at the new Roche Parenterals production facility in Kaiseraugst, Switzerland. It is concluded that by investing in the changes required to achieve “Japan Quality”, Western manufacturers will not only boost their sales within Japan, but also enhance the quality of their overall production processes. “Japan Quality” is a challenge to be welcomed rather than feared. Striving to meet its requirements makes sense – globally as well as regionally. Key words Cosmetic defects • Cultural difference • Kaizen • Lean Six Sigma • Operational Excellence • Parenterals • Pharmaceutical manufacturing |
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pharmind 2011, Nr. 5, Seite 912
