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 |
§ 111.120 - What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?
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§ 111.120 What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?
Quality control operations for components, packaging, and labels before use in the manufacture of a dietary supplement must include:
(a) Reviewing all receiving records for components, packaging, and labels;
(b) Determining whether all components, packaging, and labels conform to specifications established under § 111.70 (b) and (d);
(c) Conducting any required material review and making any required disposition decision;
(d) Approving or rejecting any treatment and in-process adjustments of components, packaging, or labels to make them suitable for use in the manufacture of a dietary supplement; and
(e) Approving, and releasing from quarantine, all components, packaging, and labels before they are used.