The world’s leading testing, inspection and certification company announced today that its Fairfield laboratory has earned its ISO/IEC 17025:2017 certification.
The globally recognized accreditation, together with Fairfield’s extensive experience as a GMP FDA approved laboratory, allows SGS to clearly demonstrate the reliability of its drug development testing results, as well as the integrity, competence and overall quality of the Fairfield laboratory’s practices.
A highly respected quality certification
ISO/IEC 17025:2017 is a globally recognized quality management standard for testing and calibration laboratories. ISO/IEC 17025 certifies technical competence in lab testing and calibration services.
The accreditation covers a wide range of chemical testing and in vitro cytotoxicity (IVT) testing for finished medical devices, medical device components, drugs and packaging.
The chemical testing includes a wide range of tests, namely:
- Extractables and Leachables (E&L);
- Analysis of medical devices through Non-Volatile Residue (NVR) analysis;
- Liquid chromatography (LC-MS/UV), headspace (HS) or direct-injection gas chromatography (GC-FID/MS) and inductively coupled plasma mass spectrometry (ICPMS).
All of these tests are assessed per ISO 10993-18 and ISO 10993-12, except for the IVT test which is performed per ISO 10993-5 and USP <87>.
"This certification is a testament to the expertise, attention to detail and dedicated support that our Fairfield laboratory offers SGS customers every day,” said Dr. Niveen Mulholland, Vice President, Life Science North America at SGS. “We’re delighted to see their outstanding work recognized in this way. This third-party accreditation provides customers with a level of comfort that certified laboratories produce the highest level of accurate and reliable results."
For more information on the ISO/IEC 17025:2017 certification and its role in ensuring quality service for drug development teams, visit the ISO website.
To find out more about the Fairfield laboratory and its offerings for SGS customers, please contact:
Patrick Kelley
Sr. Director, Business Development, SGS Health Science
t: 805-405-5272
About SGS Health Science
SGS Health Science is a division of SGS, the world’s leading testing, inspection and certification company. Its global network of analytical testing, formulation, clinical research and clinical manufacturing solutions offer a wide range of integrated services and expertise across America, Europe and Asia-Pacific.
SGS Health Science experts are ready to support customers throughout the development and commercial manufacture of their drug products, helping ensure the delivery of safe, effective and compliant medicines to global markets.
About SGS
We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories around the world.
