(255a) FDA Update on Implementation of Quality by Design

Quality by Design is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding, and process control, based on sound science and quality risk management. Much progress has been made in the past few years to define QbD implementation approaches for pharmaceutical development and manufacturing. Recent harmonized guidelines have been published to aid in the implementation of QbD approaches including: ICH Q8 - Pharmaceutical Development and more recently ICH Q8R (draft), which discusses the fundamentals of QbD in pharmaceutical development. Additionally, ICH Q9 ? Quality Risk Management and ICH Q10 ? Pharmaceutical Quality System discuss other essential elements of implementing a QbD approach. In 2005, FDA's Office of New Drug Quality Assessment (ONDQA) began a CMC Pilot Program to explore ways of implementing QbD concepts in regulatory submission and review. This presentation will provide a brief overview of QbD concepts and recent ICH guidelines, and discuss experience gained from recent QbD submissions, including those in the CMC Pilot Program.