SGS Adds to ICP-MS Capabilities
PTSM: Pharmaceutical Technology Sourcing and Management
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
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development
March 26th 2024In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.
