Production and Process Control System: Requirements for Quality Control

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Food for Human Consumption
  6. Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
  7. Production and Process Control System: Requirements for Quality Control

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Section
111.103

What are the requirements under this subpart F for written procedures?

Section
111.105

What must quality control personnel do?

Section
111.110

What quality control operations are required for laboratory operations associated with the production and process control system?

Section
111.113

What quality control operations are required for a material review and disposition decision?

Section
111.117

What quality control operations are required for equipment, instruments, and controls?

Section
111.120

What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?

Section
111.123

What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?

Section
111.127

What quality control operations are required for packaging and labeling operations?

Section
111.130

What quality control operations are required for returned dietary supplements?

Section
111.135

What quality control operations are required for product complaints?

Section
111.140

Under this subpart F, what records must you make and keep?