Quality Management
CELLONTECH strictly adheres to GMP standards to ensure the production of high-quality products.
Quality Management
CELLONTECH operates an optimized quality management system, environmental monitoring system, and quality management system.
Quality Management System
-
Quality assurance
From raw materials to the production of medical devices and their delivery to consumers, CELLONTECH scientifically analyzes all processes and blocks all potential risk factors at each stage to continuously manage Good Manufacturing Practices (GMP) and supply safer, more effective, and superior quality medical devices.
-
Quality inspection
In order to produce high-quality medical devices, CELLONTECH focuses on its quality management capabilities by complying with Good Manufacturing Practices (GMP) regulations and conducting all quality-related activities, including chemical/microbiological testing, laboratory management, and stability testing, to ensure quality that meets consumer demands and maximize customer satisfaction.
Environmental monitoring system
-
We maintain an optimal working environment that produces high-quality products through regular environmental monitoring. All tests are conducted in accordance with stringent GMP requirements.
Environmental monitoring includes testing for airborne particles, airborne microorganisms, surface microorganisms, settling microbes, and microbial contamination on the surfaces of employees.
Quality management system certification
CELLONTECH's medical device production facility has obtained certifications for international standards (ISO 13485) and national regulations (KGMP), ensuring that products are manufactured safely, effectively, and consistently with the intended purpose.
-
- ·Certification types : Certificate of Good Manufactruing Practice
- ·Certification agencies : MFDS
- ·Certification countries : KOREA
-
- ·Certification types : ISO 13485:2016
- ·Certification agencies : South Korea KMR
- ·Certification countries : KOREA