Stipulates that the quality unit is responsible for releasing or rejecting all APIs and
intermediates for use outside of the manufacturing company and that these responsibilities
should not be delegated. The reason for this is that these decisions by the Q.C. unit should not be
questioned or overridden by production or other departments.
Although not clearly stated, this section implies that the QC unit can delegate the release or
rejection of intermediates used internally by further manufacturing.
