21 C.F.R. § 111.25
What are the requirements under this subpart D for written procedures?
Cite as 21 C.F.R. § 111.25 (2026)
You must establish and follow written procedures for fulfilling the requirements of this subpart D, including written procedures for:
(a) Calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement;
(b) Calibrating, inspecting, and checking automated, mechanical, and electronic equipment; and
(c) Maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.