Analytical quality by design for capillary electrophoresis

Abstract Quality by design (QbD) is a systemic approach of US Food drug and administration. Now, it has gained popularity and is regarded as one of the most important models in pharmaceutical science. Analytical study with this approach has improved the quality of the product. The International Conference on Harmonization (ICH) provided the steps involved in the systemic approach with predefined objectives using science and risk management to gain product, and process understanding and ultimately process control. ICH Q10 explains the holistic and integrated quality management system applicable to analytical QbD.