Quality by Design in an Era of Advanced Technologies in Life Sciences

Quality by Design (QbD) was officially introduced to the pharmaceutical industry in 2002 by the FDA's "Pharmaceutical Quality for the 21st Century" initiative, although the concept of "quality by design" had its origins earlier. The International Conference on Harmonization (ICH) also supported the implementation of QbD through its guidelines, starting with the first version of ICH Q8 in 2004, which was later revised in 2008.  

• 2002: The FDA launched the "Pharmaceutical Quality for the 21st Century" initiative, formally introducing the concept of QbD to the industry. 

• 2004: The ICH first published the Q8 guideline on Pharmaceutical Development, which codified QbD principles. 

• 2013: The FDA mandated the implementation of QbD across product and process design, setting a milestone for its widespread use in the industry.

The Life Sciences Industry seems quite open to implementing and applying the QbD approach during the development phase, due to the fact that the inherent design of the process at the beginning can result in a better overall process with better quality products and outcomes. This is especially true, considering the fact that in an upstream process, the number of variables and their criticality for the quality of the final product are multiple and sometimes difficult to control in the end.