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SGS expands its elemental impurity testing services at its laboratory in Villeneuve-la-Garenne, France.
SGS has announced an expansion of the company’s elemental analysis testing capabilities at its Villeneuve-la-Garenne, France laboratory including the addition of an inductively coupled plasma mass spectrometry (ICP-MS) system to address the updated ICH Q3D regulatory guidelines on elemental impurities, as reported in a Feb. 15, 2017 press release.
The instrument, a Thermo ICP-MS: iCAP RQ C2 – ICP-MS quadrupole analyzer, offers accurate, high-throughput testing, and is currently undergoing validation and is expected to be fully operational by the end of February 2017, SGS reports. Atomic absorption spectroscopy, inductively coupled plasma optical emission spectrometry (ICP/OES), and ICP-MS systems are currently located at the facility.
ICH Q3D Step 4 requires that a risk analysis be deployed for all drug products on the specified list of elements and their permitted daily exposure (PDE) limits. New drug products were required to comply by June 2016; and existing products must comply by December 2017.
The 2100-square-meter Villeneuve-la-Garenne laboratory was opened in June 2015 and replaced a facility in nearby Clichy. All the services offered at Clichy were transferred to the new laboratory, and additional capabilities for mycoplasma and residual DNA detection as well as amino acid analysis were added, to meet the demands of growing biopharmaceutical pipelines.
Source: SGS Life Science Services