Risk-based Quality by Design (QbD): A Taguchi Perspective on the Assessment of Product Quality, and the Quantitative Linkage of Drug Product Parameters and Clinical Performance

摘要

For good reason, quality by design (QbD) has become a topic of significant interest within the pharmaceutical industry. Whereas regulatory agencies and standard-setting organizations are moving swiftly to establish QbD guidance relevant to the needs of pharmaceutical manufacturing, much of the core science of QbD was established long ago by Dr. Genichi Taguchi and other leaders in the field of quality management. In order for the pharmaceutical industry to fully capitalize on QbD, new methods for quantitatively assessing product quality need to be established. This perspective article presents a risk-based strategy for quality assessment which uses model-based simulation to link variation in drug product parameters and clinical performance. This work is intended to provide background and introduction for a series of manuscripts dealing with QbD based on probabilistic risk assessment.