cGMP/QSR definition

cGMP/QSR means the then-current Good Manufacturing Practices/Quality System Regulations set forth in 21 C.F.R. Part 820 and 21 C.F.R Parts 210 and 211.
cGMP/QSR means cGMPs and adherence to the Quality System Regulations and other requirements set forth by the FDA and FDA Counterparts, collectively, that relate to the design, Manufacture, packing, labeling, storage and installation and servicing of medical devices.