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Regulations last checked for updates: May 14, 2025

Title 21 - Food and Drugs last revised: May 12, 2025
All TitlesTitle 21Chapter IPart 111Subpart F - Subpart F—Production and Process Control System: Requirements for Quality Control
  • § 111.103 - What are the requirements under this subpart F for written procedures?
  • § 111.105 - What must quality control personnel do?
  • § 111.110 - What quality control operations are required for laboratory operations associated with the production and process control system?
  • § 111.113 - What quality control operations are required for a material review and disposition decision?
  • § 111.117 - What quality control operations are required for equipment, instruments, and controls?
  • § 111.120 - What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?
  • § 111.123 - What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?
  • § 111.127 - What quality control operations are required for packaging and labeling operations?
  • § 111.130 - What quality control operations are required for returned dietary supplements?
  • § 111.135 - What quality control operations are required for product complaints?
  • § 111.140 - Under this subpart F, what records must you make and keep?
authority: 21 U.S.C. 321,342,343,371,374,381,393; 42 U.S.C. 264.
source: 72 FR 34942, June 25, 2007, unless otherwise noted.
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