Embracing Q3D: FDA's New Elemental Impurities Guidance

• By: Staff Editor
• Date: November 10, 2016
• Source: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm371025.pdf

Elemental impurities have been topic of discussion since 2009 when the ICH commenced work to provide an international standard to limit the impurities in drug products and ingredients. FDA too has released its guidance on the control of elemental impurities in consistent with the implementation of ICH’s Q3D Elemental Impurities guideline. The FDA guidance also addresses the United States Pharmacopeial Convention’s (USP’s) requirements which go into effect on January 1, 2018.