JW Therapeutics Quality Management System
JW Therapeutics Quality Management System

With patient safety at its core, JW Therapeutics has established an internationally aligned,science -driven, and digitally enabled quality management system to ensure product quality, regulatory compliance, and operational excellence throughout the entire lifecycle of its cell therapy products.

High Compliance
High Compliance

Aligned with domestic and international cGMP standards.

High Reliability
High Reliability

End-to-end traceability supported by reliable and data integrity-compliant systems

High Safety
High Safety

Multi-layer contamination control to ensure product safety

High Efficiency
High Efficiency

Digital tools enhance quality management and operational efficiency.

Continuous Improvement
Continuous Improvement

Quality data drive ongoing optimization and continuous improvement

Quality Policy & Objectives
End-to-End Quality Management
Digital Quality Monitoring & Traceability
Quality Policy
Quality first, everyone has a responsibility. Integrate quality awareness and responsibility into every job and every aspect.
Strictly adhere to standards and implement them in a standardized manner. Strictly abide by applicable laws, regulations, and quality management standards, and continuously strengthen quality risk management.
Patient centered approach. Adhere to high standards of quality requirements and strive to provide patients with high-quality cell therapy products.
Quality Objectives
Continuously improve the entire process quality management system to ensure stable, controllable, and traceable product quality.
Continuously improving the effectiveness of the quality management system through quality risk management, process control, and continuous improvement.
Compliance First
Compliance First

Committed to compliance with cGMP requirements and applicable regulations.

Patient Safety
Patient Safety

Ensuring product quality and patient safety throughout the product lifecycle.

Continuous Improvement
Continuous Improvement

Driving continuous optimization through guality data and performance insights.

Employee Engagement
Employee Engagement

Fostering a quality culture through the active participation of every employee.

Digital Enablement
Digital Enablement

Enabling end-to-end traceability and real-time quality monitoring through digital technologies.

Apheresis Collection
Apheresis Collection
  • Personnel Qualificationx
  • Environmental Monitoring
  • Equipment Monitoring
  • Material Monitoring
Apheresis Transportation
Apheresis Transportation
  • Temperature Monitoring
  • Shipment Tracking
  • Deviation Alerts
  • Transportation Records
Manufacturing
Manufacturing
  • Process Control
  • Equipment Monitoring
  • Material Control
  • Process Validation
Testing & Batch Release
Testing & Batch Release
  • Comprehensive Testing
  • Method Validation
  • Material Review
  • Stability Studies
Finished Product Transportation
Finished Product Transportation
  • Temperature Monitoring
  • Shipment Tracking
  • Transportation Records
  • Deviation Management
Product Infusion
Product Infusion
  • Patient ldentity Verification
  • Infusion Records
  • Adverse Event Monitoring
  • Patient Follow-up
  • Enterprise Resource Planning System

    SAP Enterprise Resource Planning System

  • MES

    Manufacturing Execution System

  • Enterprise Resource Material Control

    SAP Enterprise Resource Planning System

  • COI

    End-to-End Identity Management &Tracking