GroundRules
21 CFR 111.117: What quality control operations are required for equipment, instruments, and controls?
Where this section sits in the code
- Title 21—Food and Drugs
- 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 F—Production and Process Control System: Requirements for Quality Control
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON