Abstract

QUALITYBY DESIGN (QBD): A REVIEW

G. Naveena*

ABSTRACT

Quality by design is the current approach for quality of pharmaceuticals. As the principle of QBD demonstrates, quality is not an act, it is a habit. The product of quality drugs with a high degree of reproducibility has been made possible by a creative and scientific approach to pharmaceutical development based on scientific principles. This review gives idea about the use of QBD to ensure quality of pharmaceuticals, process parameters and quality attributes are identified for each unit operation. The goal of pharmaceutical development is to create process that reliably delivers the product expected result. Quality means customer satisfaction in terms of service, products and process. QBD is the most effective way to ensure that all pharmaceutical products are of high quality.

Keywords: Quality by Design(QBD),Process analytical Technology(PAT), Quality target product profile, critical quality attributes, Design space