Pharmaceutical Research
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Innovations in Pharma Industry

The main objec ve of pharmaceu cal development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Pharmaceu cal industry realized that Quality by Design (QbD) principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaus ve valida on burden, and signifi cantly reduce postapproval changes and also helps to build a quality in all pharmaceu cal products. Hence the applica on of QbD in pharmaceu cal product development is now a thrust area for the regulatory authori es and the pharmaceu cal industry. Interna onal Conference on Harmoniza on and United States Food and Drug Administra on (USFDA) emphasized the principles and applica ons of QbD in pharmaceu cal development in their guidance for the industry. Target product quality profi le, cri cal quality a ributes, risk assessments, design space, control strategy, product lifecycle management, and con nual improvement are the key elements of QbD. Throughout designing and development of a product with QbD, it is essen al to defi ne desire product performance profi le Target product profi le (TPP), Target product Quality profi le(TPQP) and iden fy Cri cal quality a ributed (CQA) leads to recognize the impact of raw material,Cri cal material a ributes (CMA), Cri cal process parameter (CPP), on the CQA’s and iden fi ca on and source of variability.