SGS Expands ISO 17025 Accreditation for E&L Testing
SGS has announced that its laboratory in Canada has achieved ISO 17025 accreditation, enabling the company to offer specialized extractables and leachables (E&L) testing. This enhancement comes as part of SGS's ongoing commitment to providing high-quality support to the pharmaceutical, biopharmaceutical, and medical device industries. The Mississauga laboratory is now positioned to serve clients across North America, enhancing their capacity in an essential area of laboratory testing.
The Importance of E&L Testing
As the demand for drug safety validation rises, E&L testing plays a critical role in ensuring that both new drug discoveries and the development of novel pharmaceuticals meet industry regulations. Joseph Bower, Head of Health Science for SGS in North America, emphasizes the significance of this accreditation. He stated that achieving ISO 17025 status affirms SGS's dedication to maintaining rigorous standards in laboratory operations and positions the company as a reliable partner within the pharma sector.
Understanding ISO 17025 Accreditation
ISO 17025 is an international standard that confirms a laboratory's competence in terms of quality management, operational processes, and technical capabilities. This accreditation is crucial for laboratories aiming to provide credible testing results and is recognized globally. SGS’s accreditation under this standard reflects the high benchmarks the company sets for its operations and services.
The Role of SGS’s Mississauga Lab
The recently accredited Mississauga laboratory offers contract testing services tailored specifically for pharmaceutical, biopharmaceutical, and medical devices. In addition to this new capability in E&L testing, the lab holds other certifications including Health Canada and FDA registration, as well as certifications for good manufacturing practices (GMP). The facility also boasts an ISO 9001:2015 and ISO 13485:2016 accreditation, spotlighting its comprehensive quality management processes in the design and manufacture of medical devices.
Global Reach and Services
SGS operates a robust network of over 20 laboratories across 11 countries, including North America, Europe, and Asia, making it the broadest global network of analytical laboratories focused on contract testing. This extensive reach enables SGS to deliver consistent and harmonized solutions to pharmaceutical and biotechnology companies alike, regardless of their size. The company’s services extend from Phase I-IV clinical trial management to comprehensive data management including pharmacovigilance and regulatory consultation.
Commitment to Quality and Trust
With a legacy spanning over 145 years, SGS prides itself on its commitment to quality, compliance, and sustainability. The company employs a substantial workforce of around 99,500 professionals dedicated to upholding the highest standards in testing, inspection, and certification. Their brand promise – "when you need to be sure" – underlines SGS's focus on integrity and reliability, empowering businesses to operate with confidence.
ABOUT SGS
SGS is recognized as the leading Testing, Inspection, and Certification company worldwide. Operating a network of over 2,500 laboratories in 115 countries, SGS delivers unmatched expertise and professional service. The company is listed on the SIX Swiss Exchange under the ticker symbol SGSN, reflecting its public commitment to excellence in every aspect of its offerings.
Frequently Asked Questions
What is ISO 17025 accreditation?
ISO 17025 is an international standard that specifies the general requirements for the competence of testing and calibration laboratories.
Why is E&L testing important?
E&L testing ensures that the substances that may leach from packaging or medical devices do not adversely affect drug safety.
Where is SGS’s newly accredited lab located?
The newly accredited lab is located in Mississauga, Canada, and is set to improve E&L testing capacity for clients across North America.
What other services does SGS provide?
SGS offers a wide range of services including contract testing, clinical trial management, regulatory consultancy, and data management services.
How long has SGS been in operation?
SGS has over 145 years of experience in the industry, providing high-quality services globally.
