Examples of Applying Quality by Design Principles to Analytical Methods

The application of Quality by Design principles to analytical method development practices is a science and risk based approach that begins with the identification of method requirements.  Once method requirements have been identified, an analytical technique is selected based on these requirements.  A risk assessment is then conducted to identify parameters that could potentially affect method performance. Subsequent experiments are conducted to develop a more complete understanding and control of sources of variability. Ultimately, this leads to the implementation of a robust measurement system that can support process evaluation and improvement throughout the product lifecycle. Examples that illustrate these concepts will be presented.