Code of Federal Regulations (Last Updated: July 5, 2024) |
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 |
§ 111.117 - What quality control operations are required for equipment, instruments, and controls?
Latest version.
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§ 111.117 What quality control operations are required for equipment, instruments, and controls?
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.