Eudralex Volume 3 Guideline on control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph “substances for pharmaceutical use” and general chapter “control of impurities in substances for pharmace

Titel:
Eudralex Volume 3 Guideline on control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph “substances for pharmaceutical use” and general chapter “control of impurities in substances for pharmace
Kurztitel:
EMA/CVMP/QWP/907965/2022
Internet:

https://www.gmp-navigator.com/files/guidemgr/guideline-control-impurities-pharmacopoeial-substances-compliance-european-pharmacopoeia-general-monograph-substances-pharmaceutical-use-and-general-chapter-control-impurities-substances_en.pdf

Herkunft/Verlag:

EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK

Dokumentenart:
Guideline
Inhalt:
Diese Guideline bechreibt, wie europäische Zulassungsbehörden im Rahmen eines Zulassungsverfahrens mit Arzneibuchmonographien umgehen sollen, die nicht mehr dem Stand der Wissenschaft entsprechen.

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