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Is Quality by Design (QbD) Stuck, Struggling, or Just Slow to Mature?

This is a guest blog post by Paul Thomas.  Paul is Senior Editor of Pharmaceutical Manufacturing magazine, PharmaManufacturing.com, and PharmaQbD.com. He can be reached at pthomas@putman.net, and followed on Twitter @PaulThomasPharm.

There has been a lot of discussion within pharmaceutical circles of late as to what’s ailing the Quality by Design (QbD) movement. There are those who say that nothing is. There have been some “striking success stories on how Quality by Design can reduce defects and variability,” noted FDA CDER’s Janet Woodcock at the DIA annual meeting in June. QbD is “a success story that is evolving,” she added.
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