SGS expands elemental impurity testing services at its laboratory in Villeneuve-la-Garenne, France

Investment in a inductively coupled plasma mass spectrometry system is a move to address the updated ICH Q3D regulatory guidelines on elemental impurities.

The new instrument, a Thermo ICP-MS: iCAP RQ C2 – ICP-MS quadrupole analyser, offers accurate, high-throughput testing, and is currently undergoing validation. It is expected to be fully operational by the end of February 2017. The investment complements the atomic absorption spectroscopy, inductively coupled plasma optical emission spectrometry (ICP/OES) and ICP-MS systems already located at the facility.

“With this investment, SGS and its dedicated elemental impurities team are in a position to support pharmaceutical and biopharmaceutical companies through the challenges of the new regulatory guidelines,” commented Paul Beyou, General Manager of SGS’s Villeneuve-la-Garenne facility. “SGS is dedicated to offering its clients access to the very latest technology and expertise to ensure regulatory demands can be met efficiently and with no disruption to developmental timelines.”

ICH Q3D Step 4 was published in December 2014. Since then, it has required that a risk analysis be deployed for all drug products on the specified list of elements and their permitted daily exposure (PDE) limits. The guideline came into effect in June 2016 for new drug products, and existing products will have to comply by December 2017.

The 2,100 m2 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.