Minimum QbD, Enhanced QbD, and R&D QbD – How Are They Different?
I know what you are thinking. “We have no resources for implementing a full QbD. What is the minimum requirement to call our development process a QbD?” This article addresses that question. But it also provides a roadmap to enhance the “minimum QbD” over a period of time. Ildikó...
QbD Framework – in 2 Minutes (for Scientists)
When I began my QbD journey, I was confused by the jargons that FDA or ICH used (or created) in their guidelines. After some time I understood it. But now I had to explain it to those who are new to Quality by Design. They were unimpressed due to...