By Michael Fiske, M.S., Director, Upstate Stem Cell cGMP Facility (USCGF)
CGMP regulations incorporate the concept of quality by design (QbD). This concept is used in conjunction with a quality management system (QMS) aimed at controlling the collection, processing, storage, and release of human medicinal products.
By James Drinkwater, Bioquell UK Process and Compliance Director
This paper reviews some of the current operational practices that incorporate sterility testing and provides an insight into the role of hydrogen peroxide vapor biodecontamination and continuous particle monitoring.