Purisys Adds ISO Certifications Confirming Its Commitment to Quality and Excellence

Purisys LLC, a leading supplier of active pharmaceutical ingredients (APIs), contract development and manufacturing (CDMO) services, and pharmaceutical reference materials, today announced that it has obtained two additional global ISO certifications: ISO 17025 (Testing and Calibration Laboratories) and ISO 17034 (Reference Materials Producers). These new certifications reaffirm and extend Purisys’ capabilities to provide its pharmaceutical clients with the highest quality products and services. Purisys offers a broad array of assets and expertise for the development, manufacture, and support of specialty pharmaceutical APIs and other chemical synthesis projects.

“Our company-wide commitment to the highest standards of quality has characterized Purisys from the start. We are now proud and honored to have earned these two advanced ISO certifications, as the rigorous requirements and standards for ISO accreditation are recognized as the worldwide gold standard,” said Josh Hoerner, PhD, General Manager at Purisys. “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. 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.”

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. ISO 17025 requires laboratories to implement a sound quality system and demonstrate that they are technically competent and able to produce valid and reliable results. To gain ISO 17025 certification, a company must be both consistent and proficient in testing the quality of its products. This standard covers all aspects of testing and calibration, including contracts, research and design operations, and manufacturing, along with quality and purity specifications and quality control activities. The comprehensive certification process 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 is a third level of certification focusing on Certified Reference Material (CRM) manufacturers. This certification is mandatory for CRM manufacturers since CRMs can only be manufactured by ISO 17034-accredited producers. Certification provides the highest level of quality assurance and confidence that the reference materials are produced correctly and tested in accordance with rigorous standards. All methods that the manufacturer uses to certify their CRM standards must be demonstrated to be scientifically sound and proven to be accurate and reliable. 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.