QUALITY ASSURANCE

Since its inception, OriginBio has consistently adhered to the quality principles of “Precision, Efficiency, Science, and Innovation,” regarding product quality as the lifeline of corporate development. The company strictly complies with national quality management system requirements and actively aligns with international standards, establishing a comprehensive quality control system that covers the entire process—from raw material procurement and manufacturing to final product testing—ensuring every step meets the highest hygiene and safety standards. Through intelligent production equipment and lean management, OriginBio’s products achieve high reproducibility, low inter-batch variability, and strong fault tolerance, providing reliable support for clinical diagnostics.

Thanks to its outstanding quality management practices, OriginBio has been awarded the “AAA-Level Quality Credit Enterprise” designation in Henan Province and has consistently passed quality management system audits conducted by the National Medical Products Administration (NMPA) and Henan Provincial Drug Administration with excellent results. Furthermore, the company has obtained international certifications for ISO 13485 (Medical Devices Quality Management System) and ISO 9001 (Quality Management System), signifying that its quality management has reached global industry benchmarks. Moving forward, OriginBio will continue leveraging innovation to drive quality enhancement and deliver more high-quality, industrialized solutions to the biopharmaceutical field.

SYSTEM CERTIFICATION

  • OriginBio GMP
  • OriginBio Health
  • OriginBio Biology
  • OriginBio Manufacturing