A Roadmap For Implementing Analytical QbD

Quality by Design (QbD) is a structured approach to pharmaceutical development that starts with predefined objectives. It places a strong emphasis on understanding both the product and the process, alongside rigorous process control. This methodology is grounded in solid scientific principles and incorporates Quality Risk Management (QRM) to ensure comprehensive quality assurance.

Analytical Quality by Design (AQbD) extends these QbD principles specifically to the development of analytical methods. It is a methodical and scientifically driven strategy aimed at creating robust analytical methods by first defining the expected analytical performance outcomes. AQbD relies heavily on the core QbD tools and methodologies, such as Quality Risk Management (QRM), Design of Experiments (DoE), and Multivariate Data Analysis (MVDA), to establish the Method Operable Design Region (MODR). This approach ensures that analytical methods are not only effective but also resilient to variations, ultimately enhancing the reliability and accuracy of the data generated.