21 CFR § 111.117 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

§ 111.117 What quality control operations are required for equipment, instruments, and controls?

Current through Sep 8, 2026 · Read all of Part 111

Quality control operations for equipment, instruments, and controls must include:

(a) Reviewing and approving all processes for calibrating instruments and controls;

(b) Periodically reviewing all records for calibration of instruments and controls;

(c) Periodically reviewing all records for calibrations, inspections, and checks of automated, mechanical, or electronic equipment; and

(d) Reviewing and approving controls to ensure that automated, mechanical, or electronic equipment functions in accordance with its intended use.

← § 111.113 What quality control operations are required for a material review and disposition decision?§ 111.120 What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement? →