Quality Policy

Quality Policy

Quality Assurance:

Upholding the core values centering around rules and reforms and committed to thriving relying on quality, Weijie Pharmaceuticals has been contributing to the healthcare industry by manufacturing premium pharmaceutical products with satisfactory safety and efficacy.

Adhering to the quality management philosophy of “full involvement and constant pursuit of excellence”, Weijie Pharmaceuticals has complied with the competent laws and regulations including the CFDA GCP, the Drug Administration Law, the Law on Product Quality, ICH Q7a, as well as the EU GMP, FDA regulations and cGMP, and has established and implemented a quality management system in accordance with these laws and regulations.

Audit Year and MonthAuthorityAudit ProjectAudit Conclusion
2011-04FDAFDA auditPassed
2014-05CFDAGMP certification for Weijie-APassed
2014-09FDAFDA re-audit inspectionPassed
2015-06CFDAGMP certification for Weijie-BPassed
2016-03CFDAGMP certification for Weijie-CPassed

Quality Control:

Weijie Pharmaceuticals has established a complete range of quality management policies and a well-defined three-level quality management network for the Company, the workshops and the workshop sections, has adhered to the Qualified Person policy to ensure continuing technical and quality improvement and monitoring throughout the product life cycle, providing the products meeting the international and national standards and tailored to the specific customer requirements. 


      

      The Quality Assurance Department is responsible for the organization, coordination and supervision of the entire quality assurance system; in compliance with the strict inspection policies, the Inspection Department conducts inspection on the raw materials, excipients, intermediates and final products, ensuring 100% product qualification at release.