GMP Guidelines - Downloads
FDA cGMP
- US cGMP Guide Drugs 21 CFR Part 210 Current Good Manufacturing Practice
- US cGMP Guide Drugs 21 CFR Part 211 Current Good Manufacturing Practice
- US cGMP Guide Medical Devices 21 CFR Part 800 Medical Devices - General
- US cGMP Guide Medical Devices 21 CFR Part 820 - Quality System Regulation
- US cGMP Guide Combination Products 21 CFR Part 4 Good Manufacturing Practice Requirements for Combination Products
- US cGMP Guide Biologics 21 CFR 600 - Biological Products: General
- US cGMP Guide Biologics 21 CFR 606 - Current Good Manufacturing Practice for Blood and Blood Components
- US cGMP Guide Biologics 21 CFR 610 - General Biological Products Standards
- FDA Regulations Guideline List Human Drugs
- FDA Regulations Guideline List Biologics
- FDA Regulations Guide to Inspections
- FDA Regulations Warning Letters
- FDA Regulations Electronic Records and Signatures (Part 11)
European GMP Guidelines
GMP Guides from Industry Organisations
Others
- Documents have to be ordered
- Documents can be downloaded