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
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 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 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 high quality production of all our products but also to seek ways to further optimise our production, whilst ensuring we continue to comply with rigorous and robust policies and procedures.
Celltrion is striving not only to maintain the high quality production of all our products but also to seek ways to further optimise our production, whilst ensuring we continue to comply with rigorous and robust 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
Celltrion’s high-standard quality policies prioritize consistent high-quality production and operational safety across our facilities. Our manufacturing processes and quality systems undergo regular and rigorous inspections by global regulatory authorities to ensure continuous compliance and robust control. Furthermore, all manufacturing employees receive comprehensive, ongoing training in documentation management and risk monitoring. This commitment is supported by a global quality operation group of specialists and an independent corporate audit team dedicated to maintaining the highest standards of quality assurance.
