Quality by Design (QbD) is a method aiming at improving the quality of new products by building quality into the design phase. Notwithstanding the numerous benefits of the approach to the manufacturing industry and the pharmaceutical industry specifically, research shows that the uptake has been surprisingly slow. Having understood the reasons behind the disappointing adoption of the method, and identified complexity as the main one, this paper offers an alternative called Lean QbD.
The proposed methodology’s goal is to understand the process in order to define the design and control spaces which will be used to efficiently and effectively manufacture the product and minimise regulatory risks. Case studies featuring simple guided workflows are used to illustrate how to learn from past work using visualisation and statistics as well as how to increase process understanding with Design of Experiments (DOE). Lean QbD simplifies the process of extracting information from data, and through the use of Monte-Carlo simulations ensures a robust process can be developed and transferred to manufacturing within budget constraints.