Yes. The quality unit is responsible for establishing a system to release or reject raw materials, intermediates, packaging, and labelling materials. This responsibility cannot be delegated [ICH Q7,Section 2.22(2)]. The system established by the quality unit may allow ‘other departments’ to release raw materials and intermediates (except intermediates that are for use outside the control of the manufacturer [ICH Q7, Section 2.22(1)] as long as oversight and the overall responsibility of this system remains with the quality unit.
