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
- FDA Registration of Drug Establishment
- Establishment, Registration & Listing for HCT/Ps
- American Association for Laboratory Accreditation – ISO/IEC 17025: 2017
- EMA Certificate of GMP Compliance
- Tissue Bank – State of Maryland
- Australian Government: Certificate of GMP Compliance of a Manufacturer
- WuXi ATU Inspection List
- American Association of Tissue Banks
- WuXi ATU Japan Accreditation
