part_subject: "CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS"
subpart_code: "F"
subpart_subject: "Production and Process Control System: Requirements for Quality Control"
section_number: "111.117"
section_subject: "What quality control operations are required for equipment, instruments, and controls?"
cfr_reference: "21 CFR 111.117"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 100 to 169"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
Quality control operations for equipment, instruments, and controls must include:
(a)Reviewing and approving all processes for calibrating instruments and controls;
(b)Periodically reviewing all records for calibration of instruments and controls;
(c)Periodically reviewing all records for calibrations, inspections, and checks of automated, mechanical, or electronic equipment; and
(d)Reviewing and approving controls to ensure that automated, mechanical, or electronic equipment functions in accordance with its intended use.