21 CFR 111.55 - What are the requirements to implement a production and process control system?

Regulations last checked for updates: May 02, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart E [§ 111.55 - § 111.95]

§ 111.55 - What are the requirements to implement a production and process control system?

You must implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

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 111.55