A Quality-by-Design (QbD) Approach to Quantitative Near-Infrared Continuous Pharmaceutical Manufacturing

摘要

Theuseofnear-infraredspectroscopy(NIRS) has been widelydocumented within pharmaceutical quality and manufacturing functions as a unit operation, but much less has been written about it when it comprises a central part of a pharmaceutical Quality Management Strategy. With the increased attention from industry and regulators relating to PATand QbD principles, this article will discuss the benefits of the strategic application of this philosophy when they are integrated with risk mitigation tools, design of experiments and careful selection of equipment and methods for a near-infrared method on continuous processes.