Kudo Biotechnology has a robust Quality Management System, which was established in compliance with relevant GMP requirements of global regulatory agencies including US FDA, EMA and NMPA. Our commitment to quality ensures that our customers receive only the highest quality products that are safe, effective, and regulatory-compliant.
Change control
Deviation handling
Complaint handling
Quality management review
Product quality review
Recall
Internal audit
CAPA
Lifecycle stage |
R&D |
Phase 1/2 |
Phase 3/ Commercial |
Facility and Equipment |
Calibration & preventative maintenance |
Qualification & cleaning validation; area clearance; segregation and labeling of product-dedicated equipment |
Qualification & cleaning validation; area clearance; segregation and labeling of product-dedicated equipment |
Material Management |
CoA check |
Risk-based testing & release; area clearance; segregation and labeling of product-dedicated materials |
GMP compliant testing & release; area clearance; segregation and labeling of product-dedicated materials |
Documentation |
Protocol and Record |
Manufacturing procedure & batch record |
GMP compliant QMS documentation |
Analysis Method |
Development and test |
Method qualification |
Method validation |
In Process Control |
Pre-CPP, CQA |
CPP, CMA, CQA |
Process validation |
Regulatory Compliance |
GCP, GLP |
Clinical GMP |
Clinical GMP/ Full cGMP |
