Common use of Laboratory Qualifications Clause in Contracts

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)