GMP

IL-CSM has got the necessary permissions from the local authorities.

Location CH-Burgdorf:

  • Manufacturing License for Medicinal Products and Investigational Medicinal Products (IMPs) issued by SWISSMEDIC

Standort D-Lörrach:

  • License to import Medicinal Products and IMPs into Germany (both including vaccines and sera) issued by the local authority (RP Tübingen)
  • Approval to perform the EU-Release for Medicinal Products and for IMPs (both including vaccines and sera) issued by the local authority (RP Tübingen)
  • Manufacturing License for Medicinal Products and IMPs issued by the local authority (RP Tübingen)

Complete Workflow is determined by implemented Standard Operating Procedures (SOPs), the manufacturing activities strictly adhere to cGMP-rules: Personnel is cGMP educated and trained, facilities and equipment are qualified where required.