European Commission

Eudralex V4 Annex 20: GMP Guidelines for Quality Risk Management, 2/08

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The Eudralex rules govern medicinal products in the European Union. This annex to Volume 4, EU Guidelines to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, outlines a program of quality risk management.

See section II.4 for potential application of Quality Risk Management for computer systems.

Issuing Body

European Commission

SKU: 300022 Category: