Implementing Quality by Design (QbD) in Chromatography

Abstract

Analytical methods are required to be developed at different stages of the pharmaceutical product life cycle. These activities if properly not streamlined based on the knowledge of science and process understanding may lead to a very costly and time consuming procedure. Pharmaceutical industries are striving for new policy and/or new element which can be added/replaced the existing elements of quality and risk management system. Quality by design (QbD) approach is one of the alternatives where systematic implementation of Quality Management programme can be established by better knowledge of the method parameters. Recently the concept has been also appreciated by different regulatory, especially by EMA (Europe Medicines Agency) and other ICH countries authorities over the globe. When using QbD concept for development of analytical method, analytical chemist in factstudy the additive and interactive effects of all method parameters on its continual performance. Further by using statistical mockups method operable design region (MODR) is determined. Changes within MODR are not significant and revalidation of the method is not required. Current article reviews how QbD approach can be more expressively used for chromatographic analytical method development for pharmaceuticals.