QUALITY BY DESIGN (QBD): A MODERN APPROACH FOR DEVELOPMENT OF QUALITY PHARMACEUTICALS

*Kiran Bhaskar Kudande, Sachin Jalindar Fartade and Ravindra Babasaheb Gawand

ABSTRACT

Recently the concept of ―Quality by Design‖ (QbD) gaining much attention among pharmaceutical industries for maintaining Quality. It serves as a bridge between industry and drug regulatory authorities to move towards a scientific, risk based, holistic and proactive approach for development of pharmaceutical product. It mainly covers QbD elements include defining target product quality profile, designing product, Quality Risk Management, Design of Experiment, PAT, identifying critical quality attributes, process parameters & controlling manufacturing processes to produce consistent quality over time. Also Benefits, Steps involved in Quality by Design, pillars of QbD, Analytical QbD. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals. The purpose of this review is to discuss the concept of pharmaceutical Quality by Design and describe how it can be help to ensure pharmaceutical quality & drug development.

Keywords: Quality by Design, Quality Target Product Profile, Critical Quality Attributes, Critical Process Parameter, Process Analytical Techniques, Design of Experiment.