Abstract

QUALITY BY DESIGN: A NEW APPROCH TO ANALYTICAL METHOD DEVELOPMENT

Ashwini Gayakwad*, Nitin Kanwale*, Kamlesh Mali, Kiran Bhalerao, Sujata Yadav

Abstract

QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include defining a target product quality profile, designing product and manufacturing processes, identifying critical quality attributes, process parameters, and sources of variability and controlling manufacturing processes to produce consistent quality over time. Recent pharmaceutical regulatory documents have stressed the critical importance of applying quality by design (QbD) principles for in-depth process understanding to ensure that product quality is built in by design. This article outlines the application of QbD concepts to the development of analytical separation methods. QbD tools, for example risk assessment and design of experiments, enable enhanced quality to be integrated into the analytical method, enabling earlier understanding and identification of variables affecting method performance.

Keywords: Quality by design, HPLC, Design space, Analytical quality by design.