GMP

GMP

품질시스템

㈜엑셀세라퓨틱스는 안전과 품질이 확보된 무혈청세포배양배지를 공급하고자 원료구매단계부터 제품배송단계까지 엄격한 품질보증을 수행하고 있습니다.

㈜엑셀세라퓨틱스 품질시스템 아래의 국제적 품질관리기준을 적용하고 있습니다.
  • 의약품 제조 및 품질관리기준
    (대한민국 식품의약품안전처)
  • FDA 21 Code for Federal Regulations (CFR) Parts 210 and 211, cGMP (current Good Manufacturing Practice)
  • EU GMP EudraLex – Volume 4 – Good Manufacturing Practice (GMP) Part 1
  • ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
  • ISO9001 품질경영시스템 (예정)
    ISO 13485 Medical Devices Quality Management Systems
Quality
System

MANUFACTURING AREA

cGMP PRODUCTION FACILITY

Cascade Clean Room Structure (Highest Level: ISO5)

MANUFACTURING EQUIPMENT

Mixing System
  • 10L, 50L, 100L, 200L size homo-mixing system
  • Single-use liner bags ( ~ 100 Liter) or Multi-use SUS tank (200 Liter)
Sterilizing System
  • Sterilizing filter and transfer system (single-use type)
  • Isolator or Class Ⅱ Type A2 Biosafety Cabinet for aseptic manufacturing process
Filling & Capping System
  • Semi-automatic aseptic filling system
  • Semi-automatic aseptic capping system
Labelling & Packaging System
  • Automatic labelling system
  • Automatic film shrinking system
Freezing System
  • Temperature controlled product freezing system (below -70℃)
Storage System
  • Temperature controlled product storage system (below -20℃)
Water System
  • Water manufacturing and monitoring system (Water for Injection grade)

QUALITY CONTROL SYSTEM

  • Physicochemical Analysis System

    • Osmolality test
    • Conductivity test
    • pH measurement
    • Total Organic Carbon (TOC) test
  • Microbiological Analysis System

    • Sterility test
      – Membrane filter system
    • Mycoplasma test
      – Polymerase Chain Reaction
    • Endotoxin test
      – Kinetic assay system
  • Biological Analysis System

    • Performance assay - Cell culture test
    • Enzyme-Linked immunosorbent assay(ELISA)
    • Flow cytometry
    • Tri-lineage differentiation test
    • Cell Proliferation test

LOGISTICS

  • Cold Chain Delivery System

    • Qualified single(or multi)-use thermal packaging solution (below -20℃) with PCM pack
  • Temperature Monitoring System

    • Continuous temperature monitoring by temperature data logger during distribution