Production
Celltrion implements a strict quality policy that complies with the latest global GMP regulations
01
Plan
- Risk assessment analysis
- Resource analysis
- Strategic analysis
03
Monitoring
- Internal audit
- Trend monitoring
- Deviation/change control
05
Improvement
- Immediate improvement
- Corrective Action &
- Preventative Action (CAPA)
- Procedure update
02
Performance
- Education, documentation
- Validation, calibration
- Execution
04
Evaluation
- Convene quality council
- Trend analysis
- Regulatory inspections
- Product quality review
01
Plan
- Risk assessment analysis
- Resource analysis
- Strategic analysis
02
Performance
- Education, documentation
- Validation, calibration
- Execution
03
Monitoring
- Internal audit
- Trend monitoring
- Deviation/change control
04
Evaluation
- Convene quality council
- Trend analysis
- Regulatory inspections
- Product quality review
05
Improvement
- Immediate improvement
- Corrective Action &
- Preventative Action (CAPA)
- Procedure update
Quality Policy
Celltrion does not Compromise on Quality
Celltrion does not Compromise on Quality.
All products, processes, procedures, methods, and services at Celltrion must be managed in a way that ensures consistently high levels of quality
Celltrion quality system must meet or exceed the quality requirement of world-wide pharmaceutical regulatory bodies and industries as defined by world-wide GMPs
Celltrion Quality System must place quality above all other goals to ensure consistent product quality and manufacturing processes at all times.
Celltrion is striving not only to maintain the superior quality of all products but also to improve the quality through establishing and complying with strict quality policies and procedures.
Quality
Management
System
Management
System
Celltrion carries out risk assessment of possible factors that may have an impact on the quality, safety and efficacy of the products by applying ICH Q9
Quality Risk Management and ICH Q10 Pharmaceutical Quality System to the scientific information and data that have been verified and
accumulated throughout the product development and process.
CQA(Critical Quality Attribute) and CPP(Critical Process Parameter), which may affect the quality of our products, are set,
monitored, and improved. We are continually striving for consistently superior quality as well as quality improvement.
Quality Level
The high-standard quality policies at Celltrion have allowed a continuance of near 100% high-quality production
records as well as a long, proud history of contamination-free and accident-free production records.
The level of quality at Celltrion regarding facilities, process, and quality systems are put through regulatory inspections
for adequate control by the regulatory authorities in various countries. Moreover, all employees receive thorough training
on documentation management and risk factor monitoring. The global quality operation group composed of outstanding quality
management specialists, as well as a separate corporate audit team, are doing their best to maintain consistently superior product quality.
