(166c) Application of QbD Principles to Analytical Methods

The same QbD Principles applied to the design of manufacturing processes are applicable to the design of analytical methodology. QbD elements such as understanding the science behind the methods, and improving method reliability by identifying and controlling sources of variability are key. This presentation will describe how analytical methods can be developed, validated and transferred by following QbD principles and how analytical method design space can be established. Advantages of applying QbD to analytical methodology include development of more robust methods, better understanding of analytical methods and their variability, facilitation of manufacturing process improvements and potential.regulatory flexibility allowing changes to methodology within the established design space.