21 CFR 111.303 - What are the requirements under this subpart J for written procedures?

Regulations last checked for updates: Feb 13, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart J [§ 111.303 - § 111.325]

§ 111.303 - What are the requirements under this subpart J for written procedures?

You must establish and follow written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met.

authority: 21 U.S.C. 321,342,343,371,374,381,393; 42 U.S.C. 264.

source: 72 FR 34942, June 25, 2007, unless otherwise noted.

cite as: 21 CFR 111.303