(299c) Implementing Quality by Design (QbD) for New Drug Products - A Regulatory Perspective

Quality by Design (QbD) is a science based approach for pharmaceutical development and manufacturing that begins with defining clinically relevant product attributes and then designing and implementing a process to consistently deliver desired quality product. QbD continues to be a major goal in the agency's initiative to encourage modernization of pharmaceutical manufacturing. Since the launch of the CMC Pilot Program by the Office of New Drug Quality Assessment (ONDQA) in July 2005, the office has had an opportunity to evaluate many QbD based submissions submitted both within or outside of the CMC Pilot Program. The objective of this presentation is to provide a regulatory insight about the current state of implementation of QbD, highlighting some of the benefits as well as the challenges. In addition, a regulatory perspective will be offered regarding considerations for successful implementation of QbD throughout the product life cycle.