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The quality metrics debate needs to recognize the paramount importance of quality culture over and above the mere compliance that results from meeting a quality system. What is needed is a simple reward system that identifies role models. An FDA’s Dean’s List will solve many problems: it will reward those producers that do the right thing for the patient, it will encourage innovation in pharmaceutical manufacturing, it will allow inspection resources to be applied wisely, it will make quality an effective differentiator at a time when the vast majority of manufacturing is done through outsourcing. This paper flags the responsibility of the CEO in driving the organization’s quality culture: the final safety net that assures patients only get good medicines.
