Abstract
Pharmaceutical industry is one of the most regulated sectors as it deals with life of myriad patients. This chapter describes and clarifies the historical evolution and need of quality systems in pharmaceutical drug product development especially focused on parenteral products. Quality by design (QbD)-based product development involves the following elements: (a) identification of quality target product profiles (QTPPs) followed by critical quality attributes (CQAs) for various parenteral products, (b) process design and identification of critical process parameters (CPPs), (c) design space, and (d) control strategy and continuous improvement. In addition, this chapter includes explanation of six-sigma methodology with detailed explanation of few six-sigma tools such as quality function deployment (QFD), process capability analysis, and failure mode and effect analysis (FMEA) that can be used during pharmaceutical drug product development. Author has added few case studies at the end to make reader understand that how various pharmaceutical organizations have benefitted with implementation of best practices of QbD and six sigma.
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