Production and Process Controls

Specifications would be required

• Where control is necessary to prevent adulteration, e.g., heating steps

• For identity, purity, quality, strength, and composition of

  • incoming components
    • dietary ingredients
    • ingredients
      • if not dietary ingredient, must be approved food additive or GRAS
    • substances used but not in final product
  • in-process where control is necessary
  • final product and
  • packaging and labels