Helen Winkle, Director of FDA's CDER, recently said that some standards would be extremely helpful in defining some of the ICH quality terms that are floating around out there.
A recent survey by AMR found that over 70% of nearly 200 pharma company respondents plan to launch Quality by Design initiatives in drug development and manufacturing over the next two years.....yet almost an equal number suspected that most people in their organizations didn't know what the terms meant.
We posted a brief quiz online (with a few trick questions) to see how many of you know the "chapter and verse" definitions of Design Space and all the other terms that go with Quality Systems and QbD.
If you missed it, here it is. Nobody got all the answers right, by the way, and we've already processed Starbucks' cards for the top five scorers, but if you'd like the answers, please write in.
(Admittedly, we didn't have a quality guru make up the test, as we should have done, but derived the information from ICH, FDA and ISO documents). How high did you score? Do you disagree with the definitions? Let us know!
AMS
