The FDA requires each firm to establish a quality control unit (QCU).

The QCU has the responsibility and authority to approve or reject all drug product containers, closures, in-process materials, labeling, written procedures, the authority to review production records to assure completeness and accuracy, and is responsible for the approval or rejection of all manufactured drug products.

The responsibilities and procedures applicable to the QCU must be in writing and must be followed.  The designated person(s) are required to meet the Personnel Qualification requirements [211.25], must be identified in the firm’s procedures, and must receive appropriate quality assurance training. This includes training in the particular operations that the employee performs and in current good manufacturing practice as it relates to the employee's functions.

A small firm may designate a single individual with the personnel qualifications.

QCU managers and personnel can get the training they need fast and easy with Applied's QCU 101 Online Class.