Session: QbD Topical Plenary Session

The terminology "Quality by Design," or "Planning for Quality" has been utilized in other industries for over 20 years and in pharmaceuticals for well over 7 years. In this time, many different approaches to QbD have been demonstrated and the subject has generated endless debate among the CM&C functions of pharmaceutical companies. While uniform expectations for QbD submissions have not been set, and different approaches have all gained degrees of acceptance, it is clear that the concept of enhanced understanding of underlying process fundamentals is a cornerstone of the initiative. Approaches to this enhanced understanding will be discussed, both in terms of ability to register products, as well as with regard to enhanced business performance.