Drugmakers Must Prep for Looming Metal Impurity Controls, Exec Urges

Draft International Conference on Harmonisation (ICH) guidance set for release in June will tighten regulatory controls on metal impurities in finished drug products, but drugmakers should begin analyzing planned and marketed products now, a Pfizer official urges. They should begin taking these steps despite lingering confusion about how to meet the ICH Q3D draft’s stricter concentration limits for heavy metals, Janeen Skutnik-Wilkinson, director of quality and regulatory policy for Pfizer, said Wednesday at a workshop in Bethesda, Md. The draft will offer companies options for meeting the new limits, she noted.
Washington Drug Letter