chapter  13
23 Pages

Application of Quality by Design in CMC development

ByRoger Nosal, Thomas Garcia, Vince McCurdy, Amit Banerjee, Carol F. Kirchhoff, Satish K. Singh

INTRODUCTION In August 2002, the FDA announced an initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century (1,2). The intent of this initiative was to modernize FDA’s regulation of the quality of pharmaceutical products by implementing science-based policies and standards. Companies have also been encouraged to use risk-based assessments, in particular when identifying product quality attributes, and adopt integrated quality systems throughout the life cycle of a product. A number of guidance documents have been published related to this initiative (3-8).