The quality of pharmaceutical products is the top priority for both biopharmaceutical companies and regulators. To ensure consistently high product quality and improve the efficiency of manufacturing and regulation, the US FDA introduced quality by design (QbD) to the pharmaceutical industry in its 2002 Pharmaceutical CGMP initiative, Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach (1).
Since the introduction of QbD, the FDA has taken multiple measures to promote industry-wide implementation, but the industry’s response to QbD has been mixed. Although many biopharmaceutical companies fully embrace the concept, incorporating QbD approach in their development programs, many others remain hesitant to adopt QbD and thoroughly integrate its principles into their operations. Conventional wisdom says it is better to act now and gain practical experience with QbD before regulators mandate their wholesale adoption.
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1 Pharmaceutical CGMPS for the 21st Century — A Risk-Based Approach: Second Progress Report and Implementation Plan. US Food and Drug Administration: Rockville, MD, 10 June 2015.