How was Proposal Developed?

Considerations and Process:

• Analyzed other CGMP's for common principles and requirements. Other CGMP's included:

  • FDA CGMP's, for example,
    • Food CGMP's--Food (Part 110), Low Acid Canned Food, Juice, Fish & Fishery Products, Infant Formula (proposed)

    • Drug and Device for CGMP principles

  • Industry CGMP's
    • ANPRM industry outline, USP, NNFA