Quality by Design (QbD) is currently one of the most important initiatives by the FDA. But there are still a number of questions for the industry on how to implement the new approach in daily business. As a result manufacturers have been slow to adopt PAT/QbD. In addition the concept of design space is not clearly understood and the regulatory approaches have not evolved adequately.
Some presentations by FDA representatives are available on the Web. These presentations are helpful to understand the new approach:
1. Helen Winkle, Director of FDA's CDER's Office of Pharmaceutical Science, discusses QbD efforts within three different divisions of FDA: Office of New Drug Quality, Office of Biotechnology Products and Office of Generic Drugs. To watch this video please go here.
2. In a second presentation Helen Winkle discusses the need for the industry and reviewers to focus on information that is critical to product quality and safety. This video is available here.
3. Ali Afnan, senior Fellow at FDA's Center for Drug Evaluation and Research, discusses real-time release, highlighting Aventis's work with API and finished-drug manufacturing - please see here.