Examining the basic principles of quality by design (QbD) approach in analytical studies

Abstract

Although the first application of Quality by Design (QbD) concept started for product development studies, the number ofstudies regarding its application to analytical development has been increased recently. Basically, QbD strategy in bothformulation development and analytic studies are identical logically and conceptually, but they have somedifferences in termsof its terminology and application. Essential terminology and approach differences in this concept are; the determination ofthe analytic target profile, critical method characteristics, critical process parameters, and the determination of the methodstudy area. However, the risk evaluation method which is necessary for the appropriate application of quality by design isalso an inseparable part of the analytical quality by design. Despite those terminological differences, developing a qualitybased method with the analytical design that contributes to research with an appropriately applied risk-based design qualityapproach and provides multiple advantages that will be noticed each and every time, will be useful both for researchers andauthorities who investigate license documentation and changes. Therefore, the terminology which is used for analytic qualityby design and appropriate risk evaluation approaches are explained in this study