Implementing a Quality by Design (QbD) program shouldn’t be that difficult…but it almost always is. The question is why?
There is no doubt that Quality by Design (QbD) programs can help organizations manage the inherent challenges Pharmaceutical, Biotechnology and Medical manufacturing facilities face in meeting regulatory requirements. There may be a few reasons to consider why it still remains so difficult when it is such an accepted approach.
One reason it maintains to be difficult is that there still needs to be some degree of perceived value. The other reason is that it is a bit overwhelming for the beginner to delve into the world of QbD when there are so many standards, guides, industry practices and self-proclaimed experts providing endless perspectives on the topic.