Quality Metrics - Why it Matters?
*Lawrence Yu, FDA/CDER/OPQ 


The FDA has within the past month issued a draft guidance on Quality Metrics. To provide a deeper understanding of the concepts embodied in the draft guidance, I will discuss the importance of QbD concepts to the evolution of Quality Metrics, the FDA rationale for its development and expand on the OPQs vision intended to enhance the role of a quality culture within industry. Outline 1. Product quality in relation to QbD a. QbD principles and objectives b. QbD during development and commercialization 2. FDA rationale for the development of quality metrics a. Overview of draft quality metrics guidance b. Relationships between the cGMP and quality metrics 3. Quality evolution