Regulations last checked for updates: Feb 13, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026
All TitlesTitle 21Chapter IPart 111Subpart K - Subpart K—Production and Process Control System: Requirements for Manufacturing Operations
View all text of Subpart K [§ 111.353 - § 111.375]
§ 111.353 - What are the requirements under this subpart K for written procedures?

You must establish and follow written procedures for manufacturing operations.

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 111.353
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