EU Eudralex European Medicines Agency (EMA):

EC GMP Guide

EC GCP Guide

Pharmacopoeias:

USP

EP

FDA - US Food and Drug Administration:

cGMP Guide Drugs 21 CFR 210

cGMP Guide Drugs 21 CFR 211

Guide Medical Device 21 CFR 808, 812, 820

Guide Biologics 21 CFR 600, 606, 610

Guide to Inspections

Warning Letters

Electronic Records and Signatures (Part 11)

Organizations / Standards:

ISPE GAMP Guide

ISPE Technical Guides

PDA Technical Report

APIC Interpretation

WHO (World Health Organisation):

GMP in Quality Assurance

ICH (International Conference on Harmonisation)

ICH Quality Guidelines (e.g. Q9, Q10)

PIC/S (Pharmaceutical Inspection Convention

and Pharmaceutical Inspection Co-operation Scheme)

PIC/S GMP Guide