Abstract

Throughout the lifecycle of a pharmaceutical product, it is crucial to establish analytical procedures, which can be costly and time-consuming if not simplified effectively using scientific knowledge and process expertise. Quality by Design (QbD) is a development concept that begins with predefined objectives and focuses on developing and controlling processes based on risk management and comprehensive scientific knowledge. When this concept is applied to the development of analytical methods, it is referred to as Analytical Quality by Design (AQbD). The main principles of AQbD involve understanding the Analytical Target Profile (ATP) and conducting a risk assessment for variables that may impact the effectiveness of the developed analytical method. AQbD enables the analytical process to operate within the Method Operable Design Region (MODR), allowing movement within this region. Compared to traditional methods, analytical methods developed using AQbD result in fewer out-of-trend (OOT) and out-of-specification (OOS) occurrences due to their robustness within the designated region (Graphical Abstract).

Figure 1: Graphical Abstract

Keywords:Quality; Quality by design; Analytical QbD; Analytical target profile; Design of experiment