Comprehensive Quality Systems

WuXi Advanced Therapies provides quality and reliability in our science and services.  We are committed to maintaining the effectiveness of our quality management system, employing a continuous improvement program that ensures ongoing client satisfaction while adhering to regulatory and ISO quality management systems requirements. We provide quality integrated services and continuous improvement.

Campus facilities are FDA registered and ISO 17205:2005 Certified

Quality Department Overview:

  • Supplier/Vendor qualification
  • Documentation: Batch Record Management and NCEs/LIRS/CAPAs/Change Controls
  • QA – Raw Materials
  • QA – Testing
  • QA – Manufacturing
  • Sterility Assurance
  • Training Program for new hires

Routine inspections from:

  • FDA
  • EMA
  • USDA
  • MHRA
  • KFDA

PHL Site Accreditations/Registrations/Licenses/Permits Documentation

We encourage potential and current clients to visit/audit our campus.