21 CFR 111.355
§ 111.355 What are the design requirements for manufacturing operations?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 111.355, § 111.355 What are the design requirements for manufacturing operations?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84189
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Full text
You must design or select manufacturing processes to ensure that product specifications are consistently met.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.