Gilberto Dalmaso and Frank Panofen - Particle Measuring Systems

Quality by design and single-use air sampling

17 January 2018 | By Gilberto Dalmaso and Frank Panofen - Particle Measuring Systems

Quality by Design (QbD) is a method approach to developing a quality control system using predetermined objectives. It uses the foundations of risk management and science to ensure a repeatable process to manufacture high-quality products. In 2002, the FDA launched QbD as part of its innovation initiative. This paper outlines…