Quality Assurance
International Certifications
Our facility maintains the highest international standards through comprehensive certifications and regular audits.
WHO GMP
World Health Organization Good Manufacturing Practice
Valid: 2024-2027
Valid
US FDA
United States Food and Drug
Administration
Valid: Current
Valid
ISO 14644
Cleanroom Classification Class 100
Valid: 2024-2025
Valid
CE Marking
European Conformity Declaration
Valid: Current
Valid
ISO 9001:2015
Quality Management System
Valid: 2023-2026
Valid
ISO 13485
Medical Devices Quality Management
Valid: 2024-2027
Valid
Quality Control Process
Raw Material Testing
Comprehensive analysis of all incoming materials
In-Process Monitoring
Real-time quality control during production
Finished Product Testing
Complete validation before release
Stability Studies
Long-term product stability validation