Interview with FDA’s Dr. Chris Watts on “Quality by Re-Design”

At IFPAC 2007, Emil Ciurczak interviewed Dr. Chris Watts, a key member of the original FDA PAT Team. Because the whole QbD paradigm appears to have led to some confusion re: manufacturing, Dr. Watts used the term "Quality by re-Design" to describe the way QbD is translated into the manufacturing of existing products.  Unfortunately, concerns about validation still prevent some companies from making the changes required for continuous improvement.  Existing FDA regulations already allow for these changes, as Joe Famulare, FDA's Deputy Director of Compliance told us in an interview yesterday for an article that we'll publish next month.  In the meantime, click here to hear/read Chris' interview. (...Have to agree with Mr. Ciurczak's observation that people in some standards setting organizations can be "run over by a glacier" before concrete change is seen.  That doesn't seem to be the case with ICH, but implementing the Council's high level concepts on the ground will be another story...)