Title 21

PART 111 SUBPART F

Subpart F - Production and Process Control System: Requirements for Quality Control

• 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.
• 72 FR 34942, June 25, 2007, unless otherwise noted.

21:2.0.1.1.11.6.1.1	SECTION 111.103	111.103 What are the requirements under this subpart F for written procedures
21:2.0.1.1.11.6.1.2	SECTION 111.105	111.105 What must quality control personnel do
21:2.0.1.1.11.6.1.3	SECTION 111.110	111.110 What quality control operations are required for laboratory operations associated with the production and process control system
21:2.0.1.1.11.6.1.4	SECTION 111.113	111.113 What quality control operations are required for a material review and disposition decision
21:2.0.1.1.11.6.1.5	SECTION 111.117	111.117 What quality control operations are required for equipment, instruments, and controls
21:2.0.1.1.11.6.1.6	SECTION 111.120	111.120 What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement
21:2.0.1.1.11.6.1.7	SECTION 111.123	111.123 What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations
21:2.0.1.1.11.6.1.8	SECTION 111.127	111.127 What quality control operations are required for packaging and labeling operations
21:2.0.1.1.11.6.1.9	SECTION 111.130	111.130 What quality control operations are required for returned dietary supplements
21:2.0.1.1.11.6.1.10	SECTION 111.135	111.135 What quality control operations are required for product complaints
21:2.0.1.1.11.6.1.11	SECTION 111.140	111.140 Under this subpart F, what records must you make and keep

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