Links

FDA

GMP-Guidelines von Industrieorganisationen

• cGMP Guide Drugs 21 CFR 210

• ECA Good Practice Guides

• cGMP Guide Drugs 21 CFR 211

• GMP Question and Answer Guide by ECA

• cGMP Guide Medical Device 21 CFR 808, 812, 820

• APIC Interpretation

• 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

Arzneibücher

• AMWHV

• USP

• EP

WHO

ICH

• GMP in Quality Assurance

• ICH cGMP Guide (ICH Q7) - Wirkstoffe

EU-GMP-Leitfaden

EMA

• Teil I - deutsche Version

• EMA Guidance Documents

• Teil II - deutsche Version

• EMA questions and answers: Good manufacturing practice

• EudraLEx – Volume 4 – Good Manufacturing Practices (GMP) guidelines

PIC/S

• PIC/S