CFR /  Title 21  /  Part 111  /  Sec. 111.110 What quality control operations are required for process control system?

Quality control operations for laboratory operations associated with the production and process control system must include:

(a) Reviewing and approving all laboratory control processes associated with the production and process control system;

(b) Ensuring that all tests and examinations required under Sec. 111.75 are conducted; and

(c) Reviewing and approving the results of all tests and examinations required under Sec. 111.75.