scientific case studies, and future challenges Quality-by-design (QbD) for capsule formulation and process development regulatory science relevance

2018 by Taylor and Francis Group, LLC. The manufacturing of pharmaceuticals suffers from the problem of drug development in general.1 Many drug manufacturing processes are characterized by inefficiency, waste, and a slow adoption of modern process control technologies. Thus, the pharmaceutical manufacturing sector would benefit from incorporation of new science and technology. The US Food and Drug Administration (FDA) is spearheading these changes through its Pharmaceutical Quality for the 21st Century Initiative.2 With the introduction and implementation of several key concepts such as Process Analytical Technology (PAT)3 and Quality by Design (QbD),4-6 the paradigm for pharmaceutical quality regulation has been shifting from a heavy reliance on end-product testing toward a greater focus on pharmaceutical development, process control,7 and product and process understanding.8 The Critical Path Initiative is FDAs national strategy for transforming the way FDA-regulated medical products are developed, evaluated, and manufactured.

Quality-by-design (QbD) for capsule formulation and process development regulatory science relevance, scientific case studies, and future challenges Chapter