Quality by Design (QbD): Principles, Underlying Concepts and Regulatory Prospects

Abstract

In the past decades, with substantial growth of pharmaceutical companies and the need in enhancement of quality paradigms, adoption of systematic science based technologies was an inherent demand of regulatory agencies and one such technology is Quality by Design (QbD). The approved interrelated ICH guidelines, Q8 (pharmaceutical development), Q9 (quality risk management) and Q10 (pharmaceutical quality system) drove the path in successful implementation of QbD. The primary focus of this article is made in delivering the underlying concepts that lead in framing of 7 vital elements of QbD. Foremost, the fundamental knowledge essential in setting up a “SMART” objective followed with goal articulation by defining QTPP, detailed understanding of CMAs/CPPs and essentially screening out few and important key CQAs with citing few examples of drugs, their dependent CQAs and other independent parameters by visualizing the concepts of multiple basic and advanced QRM tools and various experimental designs. A detailed understanding on design space, control strategy, life cycle development and continuous improvement are described further. Various myths and potential challenges are addressed with respect to practical grounds. QbD will potentiate regulatory authorities in promising safety of pharmaceuticals thereby acting as an omnipresent tool in drug development lifecycle.

:TJPS-2020-0056.R1