§111.60. What are the design requirements for the production and process control system?
21 C.F.R. § 111.60
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
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.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.
Source
Source: 72 FR 34942, June 25, 2007, unless otherwise noted.