Quality By Design: Concept and Applications

Abstract

Quality by design it is an approach in order to achieve quality of product in terms of customer satisfaction for pharmaceuticals. By this review we just summarised concept of quality, which is basically concerned with reliability, timely performance and economic of product. According to Sir Joseph Moses Juran “Quality could be planned and most quality associated problems have their origin in the way in which quality was planned in first place. It is based on ICH guidelines Q8 for pharmaceutical development, Q9 for quality risk management,Q10 for pharmaceutical quality system. It also compares between product quality by end product testing and by quality design. USFDA has consistently working on this matter in order to implement them on pharmaceutical industry. QbD advantages involves robustness of process, successful completion, scope for invention, enhanced understanding of method besides advantages, several disadvantages associated are internal unwillingness of industries, lack of belief in business core more time to file for generic products lack of technology to implemen