Validation/Qualification. 15.01 Determine according to Product lifecycle and guidance documents when process validation is required. X 15.02 Have a written master validation/qualification plan for the facilities, equipment/instruments, manufacturing process, cleaning procedures, analytical procedures, in process control tests and computerized systems as appropriate. These to be approved by the quality unit. X 15.03 Responsible for developing, preparing and maintaining validation documentation approved by the quality unit, including protocols, reports and associated documentation. X 15.04 Qualify as necessary all critical systems and equipment used for the manufacture and control of Product (Installation Qualification (IQ), Operational Qualification (OQ), and/or Performance Qualification (PQ)). X
Appears in 3 contracts
Sources: Development and Manufacturing Services Agreement (Radius Health, Inc.), Development and Manufacturing Services Agreement (Radius Health, Inc.), Development and Manufacturing Services Agreement (Radius Health, Inc.)