At Polpharma Biologics, we designed our facility and processes to be in full compliance with the requirements of all highly regulated markets. Our staff are thoroughly trained in cGMP and relevant ICH quality guidelines and adhere to these principles across all functions and activities.

Analytical Methods: In-Process Control and Product Release Testing

  • Drug substance and drug product in-process control
  • Drug substance and drug product release testing

Facility & Environment Control

  • Environmental monitoring of cleanrooms
  • Monitoring of utilities (water, steam and gas systems)

Additional Studies

  • Stability studies
  • Leachables and extractables