Comprehensive Quality Systems
Committed to providing 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 17205: 2005
- EMA Certificate of GMP Compliance
- Tissue Bank – State of Maryland
