That description sounds like temporary employees, and you’re not excluding them, you’re just not
calling them consultants. Temporary employees would be covered under Q7A Section 3.1, which
reads, “The responsibilities of all personnel engaged in manufacture of intermediates and APIs
should be specified in writing. Training should be regularly conducted by qualified individuals and
should cover, at a minimum, the particular operations that the employee performs and GMPs as it
relates to the employee’s functions. Records of training should be maintained”.
