Quality by Design in Pharmaceutical Development

Abstract

Design and formulation of an ideal pharmaceutical product is a tedious job for a formulator as it comprises multiple objectives. The traditional method followed for years is not only expensive and time-consuming but also needs a lot of efforts in spite of which they are unfavorable and unpredictable at times. “Pharmaceutical Quality by Design” (QbD) is a well-organized approach which focuses an attention on product, process understanding, and process control, based on a thorough knowledge of science and quality risk management. QbD is increasingly gaining confidence with an assured supply of safe and effective pharmaceuticals. Regulatory bodies like International Conference on Harmonization and United States Food and Drug Administration have realized its importance and thus guided the pharmaceutical industries to adopt its principles and applications in product development. The approach to optimize the best product and process characteristics under the given conditions utilizes the “Design of Experiment” that determines the relationship between the critical factors affecting the process and its output. Nowadays, there are various software available for the optimization of pharmaceutical products. This chapter attempts to encompass thorough knowledge about development of QbD along with its application in pharmaceutical product development and suitable software available for it.