Tag Archive | "PAT"

“Product Assurance Technology”: A Pig of a Different Color?

In his column from June’s issue of Pharmaceutical Manufacturing, Emil Ciurczak grapples with why the industry has had such a hard time getting its arms around the PAT initiative, and why so many interpretations of process analytical technologies exist. (Are all of these interpretations, he asks, merely applying “lipstick on a pig”?) The root of the problem, Ciurczak says, is that we have been distracted from PAT’s essence:

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Pharmaceutical Quality and Lessons from Toyota: Thomas Friedli on Creating a Continuous Improvement Culture in Pharma

By Agnes Shanley, Editor in Chief

Thomas Friedli, professor at the University of St. Gallen in Switzerland, and his colleagues have been studying pharma’s implementation of operational excellence principles for several years. He commented on lessons the industry might draw from Toyota’s recent quality problems, and how well the pharmaceutical industry is implementing the principles of the Toyota Production System (TPS).

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Pharmaceutical Quality and Lessons from Toyota: Thoughts from Gawayne Mahboubian-Jones

By Agnes Shanley

After FDA’s Process Analytical Technologies (PAT) and Quality by Design (QbD) meeting in Bethesda last month, Gawayne Mahboubian-Jones shared some of his views on pharma product quality initiatives and why so little change seems to have taken place in the industry since the PAT guidance was issued.  He also graded the pharmaceutical industry on its implementation of Toyota Production System (TPS) principles, and touched on quality lessons that pharma might learn from the automaker’s recent setbacks.

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Ciurczak: A Report on EuPAT 4 in Finland

By Emil Ciurczak, Contributing Editor

A week or so ago, I had the pleasant experience of a week in Central Finland. Other than I consider Finland one of the most beautiful countries in the world, the scientific stimulation was well worth the trip.
Whilst the primary reason I went was to participate in EuPAT 4 (sponsored by the European Federation for Pharmaceutical Sciences), I also had the opportunity to participate in a one-day graduate course at the University of East Finland (formerly University of Kuopio, plus two other universities).

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Holistic Quality and Compliance: A Guide For, and From, the C-Level, by John Avellanet

By Agnes Shanley, Editor in Chief

Every month brings new books on the topics of Six Sigma, Lean, Lean Six Sigma, Toyota Production System and the like. Many of these books are very fine. Most wind up going off on various tangents. And, let’s face it, many of them are excruciatingly dull (although a few of them wound up being very helpful when the leg of an old sofa fell off recently and I needed to prop it up.)

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Wanted: PAT Cartographer. Must Be Inspirational.

By Paul Davies, President, Expo Technologies, LLC

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