ABSTRACT
Since the publication of the first edition of this, volume much has changed in the world of pharmaceutical quality. The Food and Drug Administration’s (FDA) initiatives on Process Analytical Technology (PAT), cGMPs for the 21st Century, and Critical Path have created tremendous opportunities for innovation and continuous improvement in pharmaceutical development and manufacturing (https://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm). These opportunities open the door to realize the concept of quality by design and in many ways lead to a realization of a vision represented by the schematic on the cover of the first edition of this book. Within the context of pharmaceutical manufacturing, a combined report of two FDA working groups (the PAT and Manufacturing Science Working Groups) summarizes their learning and challenges with respect to innovation and continuous improvement in the pharmaceutical manufacturing sector. This report is reproduced in this chapter. Based on this report a slightly modified schematic of the vision is proposed below and appears on the cover of this second edition.
