21 CFR 111.60
§ 111.60 What are the design requirements for the production and process control system?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 111.60, § 111.60 What are the design requirements for the production and process control system?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84145
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Full text
(a) Your production and in-process control system must be designed to ensure that the dietary supplement is manufactured, packaged, labeled, and held in a manner that will ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; and
(b) The production and in-process control system must include all requirements of subparts E through L of this part and must be reviewed and approved by quality control personnel.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.