Quality by Design Approach for Pharmaceutical Product Development: A Comprehensive Review

In this era of competition, Quality is Imp factor. Quality by Design (QbD) refers to a new approach to product development. It is a modern approach for the quality of pharmaceuticals. It ensures that the quality of pharmaceutical products, safety and efficacy. It also gives a comparison between product quality by end-product testing and product quality by QbD. In this review article, steps of QbD startup plans are included. The principle of quality has been identified by the ICH guidelines.Q8-Pharmaceutical development, Q9-Pharmaceutical risk management, Q10-Pharmaceutical quality system. The aim of Pharmaceutical development is to design a quality product and manufacturing process. During the designing and development of production QbD, a company needs some elements, which are described briefly. For the Implementation of QbD, various tools are needed to be used, which have been described briefly. This paper discusses the pharmaceutical QbD and describes how it can be used to develop the pharmaceutical product.