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세포치료제생산시설(GMP Plant)

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Quality Control

For the Best Quality!!

Quality Control

  • Validation / Qualification
  • Change control
  • OOS
  • Stability test
  • CAPA program
  • Personnel Training

Product management

  • Complaint management
  • Recall
  • Returns

Inspection

  • Self Inspection
  • Supplier Audit
  • Inspection

Document management

  • Product standard document
  • Batch Record review
  • Annual product review
  • Document management

Manufacturing

Manufacturing facilities customized to the patients

The manufacturing facility of JW CreaGene dedicated to the dendritic cell therapeutics and customized to the patient was certified as an exclusive Good Manufacturing Practice (GMP) plant for biomedical products. It is equipped with 5 independent aseptic manufacturing rooms, 3 aseptic test rooms used exclusively for quality control and auxiliary facilities. It is designed with patient-customized system for the entire processes from manufacturing of complete product to shipment through aseptic procedures.

Application of KGMP cleanliness

Cleanliness is maintained at the work place in accordance with the regulations of KGMP. We are implementing real-time environmental monitoring for the districts for which high level of cleanliness must be maintained in order to manufacture safe products. In addition, we have installed the system for monitoring of temperature, humidity and differential pressure in real time in each of the work places.

Highly experienced workers

Given the characteristics of the therapeutics customized to the patients, all the workers in the area of manufacturing and quality control have majored in microbiology or immunology related areas, and are equipped with high level of understanding of the products as well as stable product manufacturing capabilities through prolonged period of practical experiences.

Relevant facilities

HVAC system(heating, ventilation, air conditioning system), 무균생산실, 품질관리 시험실, 환경모니터링 시스템, 파티클모니터링 시스템