C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION › PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS › Subpart E—Requirement to Establish a Production and Process Control System

21 C.F.R. § 111.60

What are the design requirements for the production and process control system?

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(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.

Notes of Decisions
Cited in 1 case (1 in the last 5 years), 2021–2021 · leading case: United States v. Bioanue Labs. Inc (M.D. Ga. 2021).
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United States v. Bioanue Labs. Inc (M.D. Ga. 2021). “(citing 21 C.F.R. § 111.60 ). Additionally, the Government argues that the defendants “must establish and follow written procedures for quality control as required under 21 C.”
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