ARTICLES BY MARK F. WITCHER
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FMEA Vs. System Risk Structures (SRS): Which Is More Useful?9/24/2021
In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?
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Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing?5/19/2020
This article will examine the relationship between improved continuous manufacturing (CM) and biosimilar development, paying particular attention to the reasons why biosimilars are especially promising candidates for CM development and innovation.
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Are Good Manufacturing Practices No Longer Good Enough?10/28/2019
Janet Woodcock’s recent comment on the state of pharmaceutical development,“It’s not working…,” should not surprise anyone. Her continuation, “and, it won’t work in the future," is the more surprising, and particularly troubling statement. What must we change?