21 CFR § 111.60 - What are the design requirements for the production and process control system?

---
identifier: "/us/cfr/t21/s111.60"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 111.60 - What are the design requirements for the production and process control system?"
title_number: 21
title_name: "Food and Drugs"
section_number: "111.60"
section_name: "What are the design requirements for the production and process control system?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "111"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264."
regulatory_source: "72 FR 34942, June 25, 2007, unless otherwise noted."
cfr_part: "111"
---


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

(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.