Quality by Design: Challenges for CMC Statisticians
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*Yi Tsong, FDA 

Keywords: CMC, QbD, Design space

A mutual goal of industry, society and regulators is to develop a maximal efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight. FDA initiated a quality by design critical path with such an objective in mind. Many statistical issues will be raised related to this initiative. In the design stage, there are statistical issues on designing an experiment with multiple correlated input factors and their interactions. They followed by statistical monitoring and control. Finally, statistics is involved in analysis of the information collected . Some of the information may also lead to the setting and modifying of the specifications of the attributes of the drug products. The potential of contributions and new challenges for statisticians will be discussed.