21 CFR 111.355 - What are the design requirements for manufacturing operations?

Regulations last checked for updates: Feb 12, 2026

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

§ 111.355 - What are the design requirements for manufacturing operations?

You must design or select manufacturing processes to ensure that product specifications are consistently 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 111.355