Session: Quality by Design in Generic Drug Development

Due the highly competitive marketplace for generic drugs and rising customer demand (with 65-70% of prescriptions now filled with generic drugs), accelerating generic drug development and assuring the quality of generic drugs through the product life cycle is a critical challenge. Implementation of quality by design (QbD) in generic drug development can enhance understanding of raw materials, formulation design, and manufacturing parameters, and their impact on finished product quality, which will result in more efficient and robust manufacturing process as well as higher quality products. This session will invite scientists from both generic drug industries and regulatory agencies to discuss the current practices, challenges, and opportunities for QbD in generic drug development. It is intended to provide an open forum to explore how to facilitate QbD implementation in generic drug development.