Analytical procedure development following ICH Q14: An AQbD approach

Central to the ICH Q14 approach is quality by design (QbD). ICH Q8 defines QbD as “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management,” 1 originally introduced for use with pharmaceutical process development. The overall aim of this approach is to improve the robustness of manufacturing processes and deliver a higher level of assurance for pharmaceutical product quality. Its concepts can also be applied to analytical method development, for methods used in quality control (QC) and stability testing, with the aspects of QbD defined in ICH Q8 having parallels in AQbD.