Links

FDA		GMP Guides from Industry Organisations
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)

EU GMP Guide		Pharmacopoeias
EudraLEx – Volume 4 – Good Manufacturing Practices (GMP) guidelines		USP EP

WHO		ICH
GMP in Quality Assurance		ICH cGMP Guide (ICH Q7) - APIs

PIC/S		EMA
PIC/S		EMA Guidance Documents
		EMA questions and answers: Good manufacturing practice

FDA