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Incorporating Lean Principles Into Pharmaceutical QC Laboratory Design

Source: ISPE
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By Mike Dockery, Federico Gabardi, Javier Garay, Jim Gazvoda, Luke Kimmel, Pietro Orombelli, Christophe Peytremann, Tom Reynolds, Tanya Scharton-Kersten, Graham Shoel, and Jeanne Sirovatka

This article presents a case study based on an international workshop hosted by Novartis Vaccines to prepare guidelines for incorporating lean principles into pharmaceutical quality control laboratory design. Novartis Vaccines (Novartis) has applied a structured implementation of lean principles across Quality Control (QC) laboratories in Europe, India, China, and the United States. The aim has been to significantly improve internal work processes, communications, customer interfaces, and operational performance.