There is massive competition worldwide and growing impact of Information technology, the pharmaceutical industry needs to improve its performance. Newer technologies need to be implemented that can effectively reduce cost of production and at the same time improves product quality and regulatory compliance. Quality by Design is an approach that has been offered by the United States Food and Drug Administration (USFDA) which if implemented properly can save significant amount of time and cost and at the same time can improve final product quality and regulatory compliance which can increase the speed of product to reach in to the market for the patient safety. This article discusses the background of quality by design concept, basis of Quality by Design, and its approach across the product life span and benefits that it offers
