HOLISTIC APPLICATION OF QUALITY BY DESIGN (QbD) FOR PHARMA PRODUCT DEVELOPMENT EXCELLENCE AND REGULATORY COMPLIANCE

Abstract

The realm of optimizing the drug formulations has gained significant momentum towards more systematic approach of “Quality by Design (QbD)” based strategies employing “Design of Experiments (DoE)” from the erstwhile traditional short-gun approach of changing “One Factor at a Time (OFAT)”. These traditional approaches are generally associated with multiple intricacies including utilization of greater magnitude of time, money and energy, inconduciveness to plug errors, unpredictability and inability to reveal interactions and only “just workable” solutions. In this regard, the new holistic QbD-based paradigm, i.e., “Formulation by Design (FbD)”, applicable especially in the development of drug delivery systems brings about complete understanding of the product and processes based on the sound knowledge of science and quality risk management. Further, the recent regulatory guidance’s issued by the key federal agencies to practice QbD has coerced the researchers in industrial milieu to employ these rational approaches during drug product development. Beyond the pharmaceutical formulation development, QbD has diverse applications in API synthesis, analytical method development, dissolution testing, manufacturing and stability testing. The present article describes the principles, methodology and applications of QbD in the entire product development life cycle for attaining product development excellence and regulatory compliance.