Does the Q7A Section 3 on personnel directly apply to laboratory and QA personnel, i.e., adequate number of qualifications, etc., or is it intended to apply only to the manufacturing personnel?

Manufacturing in the U.S. has come to be a synonym with production. Q7A goes back to the use
of “manufacturing” in good manufacturing practices. GMPs don’t just apply to production; GMPs
apply to all aspects of making the API. “Adequate personnel” applies to manufacturing because
that’s everybody. That’s your lab people, warehouse people, everybody that has to do with the
control, preparation, production, testing and distribution of the APIs, and it also applies to
laboratory.