By Ali Afnan, Principal, Step Change Pharma

For the past decade, industry and FDA initiatives have focused on changing the drug industry’s culture, to make drug development and manufacturing more efficient while improving product quality. How successful these efforts have been depends on whom you ask. Regulatory agencies, particularly FDA, see the glass as half full. After all, they say, the term “design space” has become part of the pharma lexicon, and leading drug companies have submitted multiple Quality by Design (QbD) applications, many of which have been approved.

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By Agnes Shanley, Editor in Chief

Thomas Friedli, professor at the University of St. Gallen in Switzerland, and his colleagues have been studying pharma’s implementation of operational excellence principles for several years. He commented on lessons the industry might draw from Toyota’s recent quality problems, and how well the pharmaceutical industry is implementing the principles of the Toyota Production System (TPS).

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