Tag Archive | "analytical methods"

QbD for Analytical Methods: FDA and Industry Perspectives


By Paul Thomas, Senior Editor

At AIChE 2011 in Minneapolis today, FDA’s Elaine Morefield, PhD, Deputy Director of the Office of New Drug Quality Assessment, spoke on “FDA Perspectives on QbD for Analytical Methods.” The topic has two sides, she said: using methods in QbD, and using QbD for methods and methods development.

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FDA Releases Strategic Plan for Advancement of Regulatory Science


FDA has released its official strategic plan for the “Advancement of Regulatory Science at FDA.” The plan covers various Science Priority Areas, and none of these areas or the discussions within should surprise anyone too much (as Dr. Hamburg and the Agency have been speaking candidly on their regulatory science goals and initiatives throughout the year). Here is the official press release page, which includes a link to a podcast with Vicki L. Seyfert-Margolis, Senior Advisor for Science Innovation and Policy in the Commissioner’s Office.

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The Analytical Pharma Organization: Going Beyond Pockets of Activity


By Bikash Chatterjee, President and CTO, Pharmatech Associates

The topic of analytics as a performance lever for continuous improvement seems both obvious and odd. Anyone who has been involved in operational excellence, Lean manufacturing, Six Sigma, Kepner-Tregoe, or other problem-solving techniques knows the value of measurement as a tool for improvement. Yet, analytics is much more than just measuring and reporting data. The concept of using analytics as a catalyst for business improvement involves transforming an organization’s decision-making process and offers a foundation for business strategy and tactics.

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From Israel, Rugged and Robust QbD


Earlier this month, Jerusalem played host to the 2nd Annual QbD Conference in Israel. The program, titled “Rugged and Robust Product Development in the Pharmaceutical Industry,” was organized by varied sponsors, from The Hebrew University of Jerusalem and University of Wisconsin to manufacturers like Teva and Perrigo.

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Thoughts on Applying QbD to Analytical Methods


By Oona McPolin, Training Consultant, Mourne Training Services

Editor’s Note: This article was originally posted on the MTS Blog—permission to republish on PharmaQbD.com has been granted by the author.

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Thoughts on Applying ICH Q8 to Analytical Methods


By Oona McPolin, Training Consultant, Mourne Training Services

Editor’s Note: This article was originally posted on the MTS Blog—permission to republish on PharmaQbD.com has been granted by the author.

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