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

1. CFR
2. ›
3. Title 21
4. ›
5. Chapter I
6. ›
7. Part 111
8. ›
9. Subpart F

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

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