At a May 11-12, 2010 conference on PAT and QbD in Bethesda, Maryland, Keith Webber, Deputy Director of FDA’s CDER, explained why the Agency will not mandate PAT for manufacturers. The “backpack video” is below.

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The cover story of Pharmaceutical Manufacturing’s May issue—“Green Processes: PAT and QbD Take Root”—looks at how drug manufacturers are beginning to leverage PAT, as well as QbD, to green their processes—that is, to reduce waste, save energy, cut back on solvent use, and so on. (The article was a follow-up to last fall’s “Pharma’s Green Evolution“, which focused on how manufacturers are going green at the facility level.) The piece explores how GSK, Allergan, DSM, and the industry in general are looking at PAT and QbD with an eye towards sustainability, and cites survey data from our readers.

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Dr. Andrew Walsh’s “Contemporary Concepts in Pharmaceutical Validation” class at New Jersey’s Stevens Institute of Technology strives to teach the precepts of Quality by Design (from statistics to risk management) to graduate students prepping themselves for careers in the drug industry, even though many of those practices might not be commonly used within the industry . . . yet.

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By Paul Thomas, Senior Editor

Attending last week’s Interphex show in New York City, it was encouraging to see the proliferation of equipment that was geared towards improving process analysis. New sensors and software were in abundance, and most of the major pieces of processing equipment being introduced (by a Bosch or a Mettler Toledo, for example) were outfitted with analytical capabilities beyond what was available in the past.

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By John Avellanet, Cerulean Associations, LLC

Editor’s Note: The following is excerpted with author’s permission from “Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine.” Publication details are at the bottom of this page.

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By Emil W. Ciurczak, Contributing Editor

ICH Guidelines Show Their Age

Editor’s Note: This article is part of a series by Emil Ciurczak highlighting the need to update current ICH guidances in light of the PAT and QbD initiatives now influencing the industry. Other articles in the series thus far include Ciurczak’s assessments of: ICH Q2 (R1), ICH Q7A, ICH Q6.

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