The concept behind Quality by Design (QbD) is to build quality into the product and processes through a systematic scientific and risk-based approach to product and process design. A collection of tools contribute to organizing the formulation development process and manufacturing development process.
QbD opens the possibility of moving away from conventional batch manufacturing to Continuous Manufacturing. This can improve the agility and flexibility of manufacturing, requiring less infrastructure, space, staff, and permit increasing production volume without the current obstacles related to scale-up of the manufacturing process. It will ensure a cost-effective production requiring less investment.