FDA Guidance for Industry: Elemental Impurities in Drug Products
Titel:
FDA Guidance for Industry: Elemental Impurities in Drug Products
Internet:
Herkunft/Verlag:
FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM509432.pdf
Inhalt:
This guidance provides recommendations regarding the control of elemental impurities of human drug products marketed in the United States consistent with implementation of International Council for Harmonisation (ICH) guidance for industry Q3D Elemental Impurities (ICH Q3D)