In EudraLex Volume 4, Guidelines for Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Part III: GMP related documents, ICH guideline Q9 on Quality Risk Management (ICH Q9), principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality, including excipients, can be found.
EudraLex Volume 4, Guidelines for Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, deel III: GMP related documents, ICH guideline Q9 on Quality Risk Management (ICH Q9) bevat beginselen en voorbeelden voor instrumenten voor kwaliteitsrisicobeheer die op verschillende aspecten van farmaceutische kwaliteit, met inbegrip van hulpstoffen, kunnen worden toegepast.