QC System
QC System In order to provide the best quality media possible, Xcell Therapeutics follows a strict quality control process from the early stages of purchasing and supplier qualification to storage and shipping solutions.
Xcell Therapeutics Inc. QC System follows
the international standards listed below.
- Regulation on Good Manufacturing Practices (GMP) for Medicinal Products (MFDS)
- 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 Quality Management Systems (Planned)
ISO 13485 Medical Devices Quality Management Systems
MANUFACTURING AREA
cGMP PRODUCTION FACILITY
Cascade Clean Room Structure (Highest Level: ISO5)
MANUFACTURING EQUIPMENT
Mixing System |
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Sterilizing System |
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Filling & Capping System |
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Labelling & Packaging System |
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Freezing System |
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Storage System |
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Water System |
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QUALITY CONTROL SYSTEM
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Physicochemical Analysis System
- Osmolality test
- Conductivity test
- pH measurement
- Total Organic Carbon (TOC) test
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Microbiological Analysis System
- Sterility test
– Membrane filter system - Mycoplasma test
– Polymerase Chain Reaction - Endotoxin test
– Kinetic assay system
- Sterility test
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Biological Analysis System
- Performance assay - Cell culture test
- Enzyme-Linked immunosorbent assay(ELISA)
- Flow cytometry
- Tri-lineage differentiation test
- Cell Proliferation test
LOGISTICS
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Cold Chain Delivery System
- Qualified single(or multi)-use thermal packaging solution (below -20℃) with PCM pack
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Temperature Monitoring System
- Continuous temperature monitoring by temperature data logger during distribution