GMP-Compliance in der Technik Umsetzung am Beispiel der Instandhaltung Johannes Krämer ZLB Behring GmbH, Marburg Korrespondenz: Dr. Johannes Krämer, ZLB Behring GmbH, Plant Engineering, Postfach 12 30, 35002 Marburg (Germany) GMP-Compliance in the Technology / Realization at example of the maintenance Key words GMP-Compliance • Pharmaanlagen, Errichtung, Instandhaltung, Planung, SicherungAfter planning and installation of pharmaceutical plants and the older they are, the maintenance of these plants becomes more and more important. During all maintenance activities, the GMP-compliance of the plant always has to be obtained. This requires a high degree of organization regarding the maintenance ac-tivities, comprehensible and manageable processes for planned and unplanned activities and a valid documentation. As the needed instruments and resources are - according to experience - not available to the requested extent, strategies have to be developed, how, nevertheless, the optimal availability of the plants can be reached with a minimum of effort. |
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pharmind 2006, Nr. 5, Seite 636