Just when you thought you knew the rules, everything changed. New regulations in both pharmaceutical and dietary supplement manufacturing have moved quality control from regulatory guidance to a combination of scientific guidance and risk management throughout the product lifecycle. This change from prescriptive guidance has altered the role of quality professionals who are now being called on to develop a flexible regulatory approach—but one based on science and quality risk management.
Curious to investigate how the industry was adapting to this new approach, Capsugel, now a Lonza company—the world’s leader in capsule dosage form solutions—organized and hosted a Quality Summit where, 80 quality professionals from North America convened in Greenwood, South Carolina, where they shared the latest industry challenges, identified alternative approaches and earmarked practices that could be adopted for world-class programs.
This white paper contains the key speakers and summaries of their presentations. The topics were selected based on what is happening in today’s marketplace.