Regulation Text
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 § 111.75 are conducted; and
(c) Reviewing and approving the results of all tests and examinations required under § 111.75 .
Authority
21 U.S.C. 321,342,343,371,374,381,393;42 U.S.C. 264.