What are the design requirements for manufacturing operations?
21 C.F.R. § 111.355
in effectEffective: 2024-07-01You must design or select manufacturing processes to ensure that product specifications are consistently met.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026
