Abstract

REVIEW ON QUALITY BY DESIGN AND ITS APPLICATIONS IN PHARMACY FIELD

Deepak Pokharkar*, Gayatri Sawale, Komal Hubale, Megha Kale and Dr. Archana Gorle

ABSTRACT

Quality by Design is the modern approach for the integrity of pharmaceuticals. It illustrates the use of Quality by Design to assure the quality of Pharmaceuticals. The pharmaceutical industry is presently adopting the QbD concept to help enhance the robustness of manufacturing processes and to promote continuous improvement protocols, structure and enhance product quality and manufacturing productivity. This review lends an idea about Pharmaceutical Quality by Design (QbD), Critical Quality Attributes and its applications. Benefits, opportunities and steps entangled in Quality by Design of Pharmaceutical products are defined. This review has been composed to describe two concepts. The first concept includes Steps, Regulatory Aspects, Quality Attributes, Quality Risk Management and Design of Experiments. These are the approaches improved for the application of QbD to manufacturing processes and are described in ICH Q8, Q9, Q10. Another concept introduced in the paper is the various applications of QbD. Uses of QbD in Analytical measurements, Process Analytical Technology (PAT), Clinical Trials and in numerous Process Controls are depicted. It additionally pertains to the approach of QbD within the Development of the COVID-19 Vaccine and the various Drug Delivery Systems. The challenges faced in implementation of QbD are discussed at the end.

Keywords: QbD, Critical Quality Attributes (CQA), Quality Risk Management (Q9), Process Analytical Technology (PAT), Regulatory Aspects.