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IL-CSM
Clinical Supplies Management GmbH
Marie-Curie-Straße 8
D-79539 Lörrach
Tel +49 7621 55 00 120
Fax +49 7621 55 00 133
info@il-csm.de
www.il-csm.de

Quality Management Approach

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

• Location CH-Burgdorf:
  Manufacturing License for Medicinal Products and as well Investigational Medicinal Products (IMP) issued by the Swiss Health authorities (SWISSMEDIC)
•  Location D-Lörrach:
   •  License to import Medicinal Products and as well IMPs into Germany issued
        by the local authority in Germany (RP Tübingen)
   •  Approval to perform the EU-Release for Medicinal Products and as well 
       for IMPs issued by the local authority in Germany (RP Tübingen)

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

Highest Quality Standards are combined with an efficient Process Management System. Business process is structured according to the model of ISO 9001:2001 and is described in detail, processes and SOPs are linked together.

The integrated approach of combining cGMP requirements with quality management criteria deriving from the ISO 9000:2001 system results in synergetic effects we highly benefit from. Location of CH-Burgdorf has been certified as meeting the ISO 9000:2001 standard, location of D-Loerrach will follow in the medium term.

Our KAIZEN-based approach to continuous quality and productivity improvement ensures success regarding our permanent endeavours in advancing our processes and services.