Quality Celltrion has a set of strict quality policies that comply with the current
global GMP regulations, including Europe and the United States.
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- Design
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- Risk Assessment
- Stategy Analysis
- Resource Analysis
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- Performance
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- Documentation
- Validation·Calibration
- Execution
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- Monitoring
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- Internal Audit
- Trend Monitoring
- Deviation·Change Control
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- Evaluation
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- Quality Council
- Trend Analysis
- Regulatory Inspection
- Product Quality Review
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- Improvement
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- Immediate Action
- Corrective Action and
Preventative Action (CAPA) - Procedure Update
- Quality Management System
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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 Policy
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Celltrion does not give in to anything that may threaten the quality of our products. Celltrion is striving not only to maintain the superior quality of all products but also to improve the quality through establishing and complying with Celltrion-specific policies and procedures. The quality policies and procedures at Celltrion are as follows:
- 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.
- Level of Quality
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The high-standard quality policies at Celltrion have allowed a continuance of near 100% high-quality production records (98% cumulative production success rate in manufacturing plant I and 97% in plant II) 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 how to manage documents and how to monitor the risk factors. 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.
