(264a) QbD (Quality by Design) an Enabler for Pharmaceutical Product Development: FDA Perspective

Quality by Design can be defined as systematic approach to development that begins with predefined objectives and emphasizes product/process understanding and process control, based on sound science and quality risk management. Implementation of QbD approach leads to improved robustness of a firm’s quality system and better assurance of product quality. The US Food and Drug Administration (FDA) encourages risk-based approaches and the adoption of QbD principles in drug product development and manufacturing. This presentation will address impact of QbD primarily as an enabler that supports patient focused drug development, allows leveraging of flexible regulatory filing strategies based on enhanced product/process understanding and supports faster speed to market of novel products and/or manufacturing techniques. There will also be a discussion of how CDER is implementing a science and risk based approach for CMC assessment of regulatory submissions and for site inspections.