Pitfalls and Opportunities in the Execution of Quality by Design in Analytical Sciences

Abstract

Quality by Design (QbD) is a systematic approach integrated with quality risk management. It uses different design approaches followed by statistical analysis to yield a quality product. Now, the pharmaceutical industries are intrested in the application of QbD principles to analytical methods and term it as Analytical QbD (AQbD), which does not essentially mean less analytical testing; to a particular extent, it means the right analysis at the right time, supported by science and risk evaluation which ensures that the analytical method can be improved throughout its life cycle. However, for that, the analyst must have sound knowledge of Analytical Target Profile (ATP), method performance characteristics, risk assessment, choice of Design of Experiment (DoE), optimization of Method Operable Design Region (MODR). Some papers have cited the importance, regulatory flexibility, theoretical aspects, and statistical analysis of AQbD, but only a few discuss the core issue of gradual implementation of QbD in analytical sciences. For seamless transition, researchers need clarification on AQbD terminologies, acceptable methods, criteria to embrace critical quality attributes (CQAs), and standards to judge the adequacy of controls. This paper summarizes the challenges and solutions for the implementation of AQbD.