(144f) Quality By Design for Drug Substance Development – An Industry Perspective

The principles that embody the Quality by Design paradigm have been increasingly adopted by pharmaceutical companies over the past number of years.  Recent ICH guidelines and health authority opinions have contributed to the formalization of these principles during development, manufacturing and in regulatory submissions. While it is clear that application of QbD principles has definitely led to increased process understanding and buying down of risk, there remain significant challenges in adopting this approach universally for regulatory filings. Through some case-studies, the benefits of adopting this approach to drug substance development and the challenges that remain will be discussed