Quality by Design (QbD) Approach in Pharmaceuticals: Status, Challenges and Next Steps

Traditional approach of formulating a new drug product is an exhaustive task and involves a number of resources like man, money, time and experimental efforts. While, using this Quality by Design (QbD) approach one can get the pharmaceutical product of desired (best) quality with minimizing above resources as well as knowing the influence of one factor over the desired associated process. Hence aim of this study is the understanding of QbD approach to design product and manufacturing process to get desired pharmaceutical product. QbD follows the concepts of ICH guidelines (Q8, Q9 & Q10) which are essential for processing a pharmaceutical process. This review emphasizes on various aspects of keynotes of QbD like ascertaining drug product quality profile, priorizing input variables for optimization, modelization & validation of QbD methodology and in the last QbD validation, scale up and production as well as the software used for QbD. Hence, QbD approach is not only useful in facilitating comprehension of the products or process but also results in an excellent and economical product which follows federal compliance.