Laboratory Qualifications. 10.4.1 BIRI is responsible for ensuring that all laboratories are compliant with cGMPs with regard to systems and equipment qualifications. 10.4.2 BIRI is responsible for maintaining appropriate cGMP (GLP) documentation procedures in the laboratories (i.e. notebooks, logbooks, sample receipt, sample tracking, SOPs, etc).
Appears in 2 contracts
Sources: Manufacturing Agreement (Xanodyne Pharmaceuticals Inc), Manufacturing Agreement (Xanodyne Pharmaceuticals Inc)