If the laboratory is part of the quality unit, must the procedures, test methods, equipment, etc., be approved by the quality unit in addition to the person in the laboratory?

It states that the quality unit is responsible for “approving all specifications and master
production instructions, approving all procedures affecting the quality of intermediates or APIs”,
and “approving changes that potentially affect intermediate or API quality.” Q7A simply defines
activities that should be performed by the quality unit. Q7A does not specify who within that
quality unit should perform specific activities. So if your quality control laboratory is part of the
quality unit, there is no expectation that there be an additional person inside the laboratory who
also approves laboratory operations.