• EU Market releases
  • Photostability Testing according to ICH Q1B
  • Stability studies for all dosage forms at various temperature / humidity
 5°C ± 3°C  / –
 25°C ± 2°C / 60% ± 5% R.H.
 30°C ± 2°C / 65% ± 5% R.H.
 30°C ± 2°C / 75% ± 5% R.H.
 40°C ± 2°C / 75% ± 5% R.H.

APPROVED GMP MANUFACTURING OPERATIONS FOR

Human Medicinal Products (Manufacturing Operations)

  • Sterile Products (batch certification)
  • Non-sterile products (batch certification)
  • Manufacture of non-sterile active substance
  • Quality Control Testing

Human Medicinal Products (Importation of Medicinal Products)

  • Quality Control Testing
  • Sterile Products (batch certification)
  • Non-sterile products (batch certification)

Human IMPs for phase I, II, III clinical:

  • Sterile Products (batch certification)
  • Non-sterile products (batch certification)
  • Manufacture of non-sterile active substance
  • Quality Control Testing