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Safety and Quality

quallitaetIn Germany, human cell and tissue transplants are regulated as medicinal products (drugs), and require a manufacturing license and pharmaceutical approval by the local and a marketing authorization from the competent authority respectively. The biological safety, all aspects of the manufacturing process and clinical application of the transplants are continually monitored and controlled by the relevant governmental authorities. DIZG has 11 manufacturing licenses for human tissue transplants.

Our biological safety system includes

  • An extensive donor screening framework
  • A comprehensive serological testing scheme that exceeds the standards set by the EU-Directives 23/2004 and 2006/17 and includes 4 Virus PCR tests
  • A validated process for the deactivation and removal of viruses, bacteria and fungi
  • In-process controls and testing of finished transplants

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SEROLOGISCHES SCREENING IM DETAIL:

Serological screening test in detail:HBsAg*, Anti-HBc*, Anti-HCV*, Anti-HIV 1/2*, HBV-NAT, HCV-NAT, HIV-NAT, HAV-NAT, TPHA*, Anti-CMV, Anti-HTLV I/II (** screening tests required by the EU Directive 17/2006 EC

Supporthotline

Phone +49.30.577 07 80 60

Telefax +49.30 65 76 30 55

distribution@dizg.de

DIZG Annual Report

jahresbericht 2015Click here to see the DIZG annual report of 2014.

It is available as a download (PDF) on the following page:

DIZG Downloads