It is generally accepted that quality cannot be tested or inspected into a finished product, but rather that quality, safety, and effectiveness must be “designed” and built into a product and its manufacturing process. To encourage new initiatives and provide guidance to pharmaceutical process developers, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use introduced the quality by design (QbD) concept. ICH-Q8 defines it as “a systematic approach to development that begins…