Abstract

Quality by Design – Application to Analytical Method Development

Mrunal Jaywant, Senior Director, USP India Private Limited

Analytical Quality by Design (AQbD) is the application of QbD principle to analytical method development based on sound scientific knowledge and quality risk management. The ultimate aim is to ensure product quality using fit for purpose analytical method. AQbD is gaining attention from different stakeholders of pharmaceutical industry as it establishes a regulatory framework and offers flexibility in regulatory filing by determination of “Analytical design space”. The concept of AQbD is used most effectively to minimize the risk of method failure during technology transfer and develop rugged/ robust analytical method that consistently delivers the intended performance throughout its lifecycle. The lifecycle concept as per ICH Q8 is adaptable to analytical procedures if we consider an analytical procedure as a process and the output of this process as the reportable result.