Quality Control Testing. All production batches of Manual Test Kits shall be manufactured in accordance with the current Good Manufacturing Practice regulations and the Quality System Regulations promulgated by the FDA, including 21 C.F.R. Part 820 and tested in accordance with appropriate quality control testing procedures prior to shipment to HDL, and Manual Test Kits failing such testing shall not be shipped to HDL.
Appears in 2 contracts
Sources: Supply Agreement (BG Medicine, Inc.), Supply Agreement (BG Medicine, Inc.)