Links

FDA

• cGMP Guide Drugs 21 CFR 210
• cGMP Guide Drugs 21 CFR 211
• cGMP Guide Medical Device 21 CFR 808, 812, 820
• cGMP Guide Biologics 21 CFR 600, 606, 610
• Guideline List Human Drugs
• Guideline List Biologics
• Guide to Inspections
• Warning Letters
• Electronic Records and Signatures (Part 11)

Deutschland GMP

• Pharmabetriebsverordnung

WHO

• GMP in Quality Assurance

EG-GMP-Leitfaden

• Teil I
• Teil II

GMP-Guidelines von Industrieorganisationen

• ECA Good Practice Guides
• GAMP Guide
• ISPE Technical Guides
• PDA Technical Report
• APIC Interpretation

Arzneibücher

• USP
• EP

ICH

• ICH cGMP Guide (ICH Q7) - Wirkstoffe

EMEA

• EMEA GMP Guides

PIC/S

• PIC/S GMP Guide