21 CFR §111.110
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.