This project has been archived.

Quality by Design Working Group (API)

The API Leadership Group recently formed a Quality-by-Design (QbD) Working Group to share industry experience with QbD and further develop our practices in this evolving field. The QbD group is exploring the following topics:

The API QbD Working Group are currently focussed on developing a set of case histories to exemplify the verification of a design space on scale and respond to a recent FDA/EMA Q&A paper on that topic.