Risikomanagement nach GAMP 5 Sieghard Wagner Chemgineering Business Design GmbH, Stuttgart Korrespondenz: Sieghard Wagner, Chemgineering Business Design GmbH, Heßbrühlstraße 15, 70565 Stuttgart (Germany), e-mail: sieghard.wagner@chemgineering.com GAMP 5 transfers risk management according to ICH guideline Q9 and/or Annex 20 to the practical application in computerized systems validation. Following a life-cycle approach, GAMP defines seven building blocks any risk management is composed of. Starting with risk based decisions on whether a system has to be validated at all, explicit and detailed risk assessments are requested from all quality or GxP relevant decision points. Risk management only ends with the controlled and supervised system retirement; potential GxP risk concerns must always be taken into consideration when shutdown processes are planned. The seven risk management building blocks facilitate the implementation of the required “risk-based approach”. Some deficiencies in operational feedback and the inclusion of feedback data into the risk management process remain; however, the periodic review process offers a feasible solution for this problem. Therefore, the GAMP 5 risk management approach constitutes an essential, indispensable element of efficient validation: GxP risks are the only recognized and acknowledged decision criteria for what must and must not be done during validation. Key words Lebenszyklusmodell • Periodic Review • Risikoanalyse • Risikomanagement • Softwarekategorien • Validierung computergestützter Systeme |
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pharmind 2010, Nr. 9, Seite 1637
