For every handful of die-hard conservatives clinging to the old-fashioned ideas of pharmaceutical product quality testing, there is one who is interested in applying scientific manufacturing principles and the concepts of Quality by Design, and the number of those in this avant garde, is, fortunately, growing. This article by Angelo De Palma shows how the principles are being applied at Wyeth and other companies, and includes an interview with FDA's Moheb Nasr, whose office is driving QbD within FDA.
And now for a bit of trivia....because reading about the origins of QbD, and those who pioneered the concept in other, very different industries is interesting, too.
Joseph Moses Juran ( a living legend in quality circles, now over 100 years old) first coined the phrase QbD in a book by that title (whose cover photographer really could have done better; made the quality legend look like the quintessential grumpy old man) Juran built upon the work of many others, including Vilfredo Pareto (the man behind those diagrams so many of you are using), but, interestingly enough, was interested in the "people" dynamics of quality management, and greatly influenced by the work of anthropologist Margaret Mead.
And of course you all know about W. Edwards Deming. (But did you also know that he was an amateur musician and composer? Check out his compositions here)
Walter Andrew Shewhart was another important figure in this movement.
Critical were those in Japan, who reinvigorated Deming's work and added some unique, and widely imitated twists of their own, notably, Kaoru Ishikawa, Taishi Ohno and Shigeo Shingo.
Speaking of Margaret Mead....Have you any interesting folklore or anthropological stories from pharma to share?
-AMS
