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Purisys is now certified for ISO 17025 for testing and calibration laboratories and ISO 17034 for reference material producers
Purisys, which supplies APIs, pharmaceutical reference materials, and contract development and manufacturing services, announced in a July 7, 2021 press release that it has obtained two additional global ISO certifications: ISO 17025 for testing and calibration laboratories and ISO 17034 for reference materials producers.
“We are currently broadening our API business to include additional categories of drugs, expanding our services to make our product development and testing expertise available to more drug developers, and enlarging our reference materials catalog,” said Josh Hoerner, general manager at Purisys, in the press release. “These new certifications support these efforts by opening new markets that mandate ISO certification as a requirement for reference standards and providing our growing client base with added confidence in the exceptional quality of our work.”
According to the press release, ISO 17025 provides a second level of certification, beyond the core ISO 9001-compliant quality management system standard, by certifying that quality-oriented tests are performed correctly, and that the organization produces quality products. A certification process for the standard includes assessments of the qualification and training of personnel involved in the testing, as well as the qualifications of relevant vendors and subcontractors.
ISO 17034 certification is mandatory for certified reference material (CRM) manufacturers because CRMs can only be manufactured by ISO 17034-accredited producers. ISO 17034 certification uniquely includes standards for risk assessment, requiring that all potential sources of error involved in certifying the standard be reported on the certificate of analysis.