By Paul Thomas, Senior Editor

This week at DIA 2011, at Chicago’s McCormick Place, Moheb Nasr, director of FDA CDER’s Office of New Drug Quality Assessment (ONDQA) and a key member of the ICH Quality Implementation Working Group, provided an overview of the working group’s recent activities and future goals. The Q-IWG has spearheaded the development and implementation of ICH Q8, Q9, and Q10, and Nasr stated that it has made great progress towards achieving its goals, but outlined current and future challenges as well.

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From time to time on this site, we’ll reflect upon articles that we feel have been particularly noteworthy in explaining some aspect of Quality by Design, and in advancing the movement. Sort of a Greatest Hits of QbD, if you will. (We would love to hear your nominations for this “album”. Send suggestions for classic articles from any publication or web site to pthomas@putman.net or ashanley@putman.net.)

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By Bill Schmidt, Principal, Tunnell Consulting

Quality by Design (QbD) is unquestionably ready to help your organization solve the perennial challenges of drug development and manufacturing. The real question is whether your organization is ready for QbD. Answering that question begins with an understanding of QbD basics, benefits, and barriers to implementation, followed by a readiness assessment that can ensure that you have the right mindset, priorities, and resources aligned for a successful implementation.

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By Agnes Shanley

Anyone looking for hopeful signs of change in the ongoing industry/FDA impasse on smart manufacturing–specifically, PAT and QbD–was bound to be disappointed by this week’s FDA “Partnering with Industry” meeting in Bethesda.

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FDA has made available a final version of its “Q8, Q9, and Q10: Questions and Answers” document, an updated version of previous Q&A documents that had been released by the ICH Quality Implementation Working Group.

The guidance is helpful for QbD professionals and trivia buffs alike. Some of the questions that are addressed:

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Insights from our QbD Chat video series, with Bikash Chatterjee of Pharmatech Associates.