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Quality by design (QbD) is an approach that aims to ensure the quality of medicines by employing statistical, analytical, and risk‐management methodology in the design, development, and manufacturing of medicines. It focuses on the use of multivariate analysis, often in combination with the modern process and analytical chemistry methods, and knowledge‐management tools to enhance the identification and understanding of critical attributes of materials and critical parameters of the manufacturing process. This enhanced understanding of product and process is used to build quality into manufacturing and provide the basis for continuous improvement of products and processes.⁵⁵

One of the goals of QbD is to ensure that all sources of variability affecting a process are identified, explained, and managed by appropriate measures. This enables the finished medicine to meet its predefined characteristics consistently.

The concepts behind QbD were introduced into international pharmaceutical guidelines between 2009 and 2012. EMA accepts applications that include QbD concepts.