EAG Labs Opens ICP-Mass Spec Lab
11.03.16
Aims to address enhanced regulation of metals and impurities in pharmaceuticals
EAG Laboratories, a global scientific services company that provides testing, analytical and characterization services to technology- and life science-related industries, has invested in a dedicated, high-throughput lab that aims to address more rigorous requirements for the determination of elemental impurities in human drug products.
The expansion includes six new Inductively Coupled Plasma/Mass Spectrometry (ICP/MS) instruments at its cGMP pharmaceutical lab in Columbia, MO.
Although controlling metals and other impurities has long been a concern for drug manufacturers, recent guidance sets stricter limits and outlines analytical procedures for compliance. Recommendations published in June 2016 by the U.S. FDA seek to align U.S. regulation with the International Council for Harmonization (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.
"The pharmaceutical industry has a critical need for high-quality contract laboratory partners who understand the guidelines, can perform required risk assessments and have the capacity to execute validated analytical procedures," said EAG's CEO, Siddhartha Kadia, Ph.D. "EAG brings decades of experience and expertise in metallurgical analyses and impurity characterization to these latest regulations."
The expansion includes six new Inductively Coupled Plasma/Mass Spectrometry (ICP/MS) instruments at its cGMP pharmaceutical lab in Columbia, MO.
Although controlling metals and other impurities has long been a concern for drug manufacturers, recent guidance sets stricter limits and outlines analytical procedures for compliance. Recommendations published in June 2016 by the U.S. FDA seek to align U.S. regulation with the International Council for Harmonization (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.
"The pharmaceutical industry has a critical need for high-quality contract laboratory partners who understand the guidelines, can perform required risk assessments and have the capacity to execute validated analytical procedures," said EAG's CEO, Siddhartha Kadia, Ph.D. "EAG brings decades of experience and expertise in metallurgical analyses and impurity characterization to these latest regulations."
