What quality control operations are required for laboratory operations associated with the production and process control system?
21 C.F.R. § 111.110
in effectEffective: 2024-07-01Quality 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.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026