Designing Quality: Quality by Design in the analytical pharmaceutical development.

The present thesis study describes an integrated approach for the implementation of Quality by Design principles to screening and development of analytical methods applied to vaccines physical-chemical testing, according to Analytical QbD (AQbD) published in literature. The research study is focused on application of the risk assessment and the experimental design tools to be used to build knowledge about the analytical methods performance and to mitigate the risks of failure. Risk management tools and mathematical/statistical models have been applied to study and define well characterized analytical methods (based on understanding of method parameters-performance relationships), in order to establish an analytical procedure able to ensure the desired performance and to identify the method design space. The AQbD structured approach clearly mitigates the risk of failure and provides advantages in a life-cycle management prospective.