21 C.F.R. § 111.110

What quality control operations are required for laboratory operations associated with the production and process control system?

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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.