OR WAIT null SECS
Dedicated facility will address enhanced regulation of metals and impurities in pharmaceuticals.
EAG Laboratories, a scientific services company that provides testing, analytical, and characterization services to life-science-related industries, announced on Nov. 3, 2016 a new high-throughput laboratory to test for elemental impurities in human drug products. The expansion includes six inductively coupled plasma/mass spectrometry (ICP/MS) instruments at its cGMP pharmaceutical laboratory in Columbia, MO.
Recommendations published in June 2016 by FDA seek to align US regulation with the International Council for Harmonisation (ICH) Q3D guidance and previously published United States Pharmacopeia (USP) requirements. The regulations affect manufacturers of brand-name, generic and over-the-counter drugs and require compliance by January 1, 2018.
“ICP/MS is the best choice for elemental metals analysis because of its high sensitivity, specificity and ability to monitor all metals simultaneously,” said EAG Senior Scientific Advisor, Wayland Rushing. “These instruments allow us to measure impurities more precisely and more quickly than older technology, and the new laboratory’s capacity and redundancy supports the high sample volumes we will see in the coming year.”
EAG’s facility in Syracuse, NY, also performs the initial survey screens required on drug product and drug substance, as well as ICP/MS method development services. Multiple EAG facilities worldwide can identify, characterize, and investigate sources of impurities that can occur in pharmaceutical ingredients, manufacturing processes, and packaging.
Source: EAG Laboratories