quality

  • Quality assurance
  • Quality control

Quality control

Accurate and reliable quality control system

QC test area is isolated from production area, API and Fill and Finish areas, in order to achieve strict and accurate quality control for biopharmaceuticals. It is comprised of physical/chemical, microbiology and bioassay laboratories in accordance with ICH and PIC/S, MFDS, FDA, PMDA and EU GMP guidelines and regulations for all processing starting from raw materials to final products. At physical/chemical laboratory, we spatially separated and deployed each room; testing laboratories for various tests(HPLC, Lab, GC lab), QC sample receiving and archiving room, Reagents and standards storage, Stability testing room, Weighing room and Janitor.
Microbial limit testing, sterility testing, bioburden testing and endotoxin testing are conducted in microbiology laboratory. Microbiology Laboratory is built to prevent cross-contamination so that accurate and reliable testing is conducted in a way of separating each room clearly; individual Test room, Reagents and standards storage, Media preparation room and Decontamination room. Bioassay laboratory is separated from others and used for cell-based bioassay, for biopharmaceuticals such as monoclonal antibodies.

Major QC Test

  1. 1Raw material QC testing
  2. 2OOS(out of specification) investigation
  3. 3Lot release testing
  4. 4Analytical method transfer and validation
  5. 5Stability testing
  6. 6Comparability testing
  7. 7Packaging material testing
  8. 8Environmental monitoring
    (including utility analysis such as air, gas and water)

Equipment and test list for each test area

Equipment and test list for each test area
Test areas Main equipment Major test list
Physical/Chemical
Laboratory
  • HPLC
  • Gas chromatograph
  • ICP-OES
  • Capillary electrophoresis system
  • Bio-LC
  • Real time PCR, etc.
  • Assays (e.g. UV/VIS, IR, etc.)
  • Chromatographic testing
  • Identification of active ingredients and impurities
  • Physicochemical determination
    (pH, conductivity, viscosity, melting point,
    osmolality, loss on drying, etc.)
  • Limit tests (heavy metals, etc.)
  • Analysis of water for pharmaceutical purpose
    (TOC, conductivity)
  • Stability testing
Microbiology
Laboratory
  • Biological safety cabinet
  • Refrigerated incubator
  • Autoclave
  • Microscope
  • Microplate reader
  • Endotoxin detection system, etc.
  • Microbial limit testing
  • Sterility testing
  • Bacterial endotoxin testing
  • Bioburden testing
  • Microbiological tests in individual process media
    (air, water and technical gases)
  • Confirmation of personnel hygiene
  • Determination of microbiological exposure
    on clothing and hands of production personnel
  • EM (environmental monitoring)
Bioassay
Laboratory
  • CO2 incubator
  • Microscope
  • Microplate reader
  • Biological safety cabinet
  • Microplate reader
  • Autoclave, etc.
  • Cell-based bioassay
  • Cytotoxicity (ADCC and CDC)
  • Other product-specific bioassays