Quality by Design in Pharmaceutical Development

More than 70% of the prescriptions in the US are now filled with generic products, and therefore, the industry has the responsibility to continue to provide safe, effective, and affordable medications. In 2009 GPhA initiated a dialogue between the Industry and the US FDA Office of Generics on Quality by Design (QbD) - a systematic approach for designing quality in our products. To facilitate the discussion between the two, FDA provided hypothetical cases on quality target product profile, compatibility between drug and excipients, formulation and process development, and scale-up and control strategies. While many questions still remain to be addressed, there is general agreement between the industry and the FDA on the benefit of quality by design. The purpose of this presentation is to provide the generic industry perspective on QbD.