21 CFR 11, 110, 117, 120 - Food GMPs OECD Expenses & Reports (1 Draft

Expenses & Reports (1 Draft & 1 Final)

International Council for Harmonization (ICH):

Part 320 Bioavailability and bioequivalence requirements

EU GMPs Annex 1 Sterile Drug 2023

Part 610 - General Biological Products Standards

21 CFR 11, 110, 117, 120 - Food GMPs OECD Expenses & Reports (1 DraftFDA announced replacement of 21 CFR Part 110 Food GMPs with the new regulation 21 CFR Part 117 CGMP, Hazard Analysis, and Risk Based Preventive Controls for Human Food. US FDA Title 21 CFR Parts: Part 11 Electronic Records Electronic Signatures (ERES) Part 110 CGMP in Manufacturing, Packaging or Holding Human Food Part 117 CGMP, Hazard Analysis, and Risk Based Preventive Controls for Human Food Part 120 Hazard Analysis and Critical Control Point