Analytical Quality by Design – What’s it all about?

Systematic approach to method development, optimization and analysis
The objective is to understand the method in depth to avoid unexpected and OOS results or issues with the method down the line
Most of the work is performed in the Method Development stage where all the critical operator and method parameters need to be assessed
This approach should generate a robust method for analytical assessment going forward
The risk of needing significant change to the method and re-qualification or re- validation is then minimized

Early effort reaps rewards

Understanding method limitations is crucial