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« Back to: Global GMPs

Background - US GMPs for Active Pharmaceutical Ingredients (API)

  • 1938, Federal Food, Drug & Cosmetic Act
    • APIs are subject to the adulteration provisions of Section 501(a)(2)(B) of the Act, which requires all drugs to be manufactured in conformance with CGMP.
  • 1978, 21 CFR 210/211
    • FDA has long recognized that the CGMP requirements in the good manufacturing practice regulations for finished pharmaceuticals (21 CFR Parts 210 and 211) are valid and applicable in concept to API manufacturing.
    • FDA has not promulgated CGMP regulations specifically for APIs or drug components.
  • 1998, Guidance for Industry: Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients
    • Applies to the manufacture and control of drug and biologic APIs for use in human and veterinary drug products.
  • 2000, ICH Q7, GMPs for APIs
    • FDA, "This guidance represents the...(FDA's) current thinking on this topic."