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.
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology