Chapter 1 - Quality by design as an emerging concept in the development of pharmaceuticals

Abstract

Recently, quality by design (QbD) approach is widely being used in the field of pharmaceuticals due to their several advantages. This approach gives a better process and product understanding before its development, which ultimately helps in the development of a better-quality product. Nowadays, there are several new drug applications and abbreviated new drug applications filings observed in the field of pharmaceutical product development, biotechnological product development as well as for the development of new chemical entities by employing the QbD approach. This chapter focuses on the emergence of QbD as a quality tool as well as in detail involved steps within it. Moreover, this chapter also looks at applications of QbD in different fields. Last, this chapter also gives information about regulatory guidelines and hurdles in the implementation of QbD.