Tag Archive | "process validation"

PAT, QbD and Process Validation – The Enablers of Pharmaceutical Quality


This presentation delivered by Vibhaker Shah, Ph.D., FDA Senior Policy Advisor, is a great reference resource on the merits of QbD, PAT and their links to the fairly new Process Validation guidance.

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Tech Transfer’s New Framework


Technology transfer has become a more critical, yet more complex, concern for many drug manufacturers—especially larger companies that have sought to bolster their pipelines through acquisition. In such cases, say Bikash Chatterjee and Mark Mitchell of Pharmatech Associates, “the control and consistency of development data can vary dramatically.”

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Drug Manufacturing: Still Waiting for the Sea Change?


In Pharmaceutical Manufacturing’s April issue cover story, Agnes Shanley takes “The Pulse of Pharmaceutical Manufacturing.” The past decade has seen dramatic shifts in the way we talk and think about drug manufacturing, but, she asks, have practices really changed in the time since FDA’s PAT team was formed and then-Commissioner McClellan wondered why pharma manufacturing was “behind that of potato chip and soap making”?

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Ajaz Hussain on the State of Pharmaceutical Manufacturing


By Agnes Shanley, Editor in Chief

PharmaQbD: Has drug manufacturing advanced in the last decade?

A.H.: I’ve probably kept up more on the regulatory side and what’s happening with different companies. The progress seems to be slow when one looks at news reports on shortages, recalls and other quality issues. Prevention of such issues was, in part, the motivation for FDA to launch the PAT and then the CGMP for the 21st Century Initiative.

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Channeling Don McLean


By Ali Afnan, PhD, Principal, Step Change Pharma, Inc.

February can be a difficult month, even when the winter is as mild as the one we just experienced in much of the U.S. But, for anyone working in or observing the pharmaceutical industry, this February brought to a climax the swell of bad drug manufacturing news that had been building since last year. Some of the lowlights:

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QbD and FDA’s Process Validation Guidance: Square Peg, Round Hole?


By Paul Thomas, Senior Editor

At the beginning of his talk at last week’s Bioprocess Development & Production Week event in San Diego, Amit Banerjee, a research fellow in global biologics with Pfizer, posed the following question: Is the QbD approach aligned with FDA’s new Process Validation guidance?

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