cGMP

Current Good Manufacturing Practice (cGMP)

United States:

• Current Good Manufacturing Practice Regulations
  • Finished Pharmaceuticals (human and animal products): 21 CFR 210 and 21 CFR 211
  • Biological products: 21 CFR 600
  • Blood and blood-derived products: 21 CFR 606
  • Medical devices (“Quality System Regulation”): 21 CFR 820
  • Food for human consumption: 21 CFR 110
• Pharmaceutical cGMPs for the 21st Century: Guidance Document
• GMP requirements for Active Pharmaceutical Ingredients (APIs): Q7A

Australia:

• Australian Code of Good Manufacturing Practice for Medicinal Products

Canada: 

• Good Manufacturing Practice (GMP) and guidance documents

European Union:

• Good Manufacturing Practice and Good Distribution Practice Compliance