Links

Links

Links to regulatory resources:

Links zu regulatorischen Dokumenten und anderen Quellen:

Links utili per documenti ufficiali e altre informazioni:

WHO Medicines         ICH         PIC/S

USA 21CFR210         USA 21CFR211         USA 21CFR Medical Devices         USA 21CFR Biologics

CDER Guidance         CBER Documents         ORA Guide to Inspections         FDA Warning Letters         ORA Electronic Records (Part 11)

European Commission: Pharmaceuticals         EMEA

PDA         GAMP         ISPE         APIC

USP

Ph Eur