Tuesday, 20 November 2018

FDA - Elemental impurities in drug products

FDA has issued a new guidance document: “Elemental Impurities in Drug Products Guidance for Industry.”

This guidance provides recommendations regarding the control of elemental impurities of human drug products marketed in the USA consistent with implementation of ICH guidance
for industry Q3D Elemental Impurities This guidance will also assist manufacturers of compendial drug products in responding to the issuance of the USP requirement for the control of elemental impurities.

See: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm509432.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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