Purisys, a supplier of APIs, CDMO services, and pharmaceutical reference materials, announced two advanced global ISO certifications—ISO 17025 & ISO 17034.
ISO 17025 (Testing and Calibration Laboratories)
- ISO 17025 provides a second level of certification beyond ISO 9001 by certifying that quality-oriented tests are performed correctly, and that the organization produces quality products consistently.
- 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.
- ISO 17025 requires labs to demonstrate technical competence and produce valid and reliable results.
ISO 17034 (Reference Materials Producers)
- 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.
These additional ISO certifications are important because Purisys is broadening its API business to:
- Include additional categories of drugs
- Make the company’s product development and testing expertise available to more drug developers
- Expand and grow its reference materials catalog.
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