FDA-gerechte Qualifizierung von Anlagen in der Wirkstoffproduktion Ralf Gengenbach gempex GmbH Korrespondenz: Ralf Gengenbach, Durlacher Str. 86a, 76229 Karlsruhe (Germany), FDA-compliant Qualification of Manufacturing Plants for Active Pharmaceutical Ingredients Qualification of pharmaceutical production plants is strictly forced by GMP (Good Manufacturing Practice) regulation and as an essential part of the overall quality assurance system can not be passed. Nevertheless there is still a great uncertainty in case of how to do the qualification in detail especially with view to the implementation of qualification activities within the proceeding process of planning and erecting a new and complex production plant. Also the subject optimization of already existing qualification and validation systems still is challenging the responsible persons especially at the time when cost reduction is a major issue. The following article describes after a short statement about regulatory requirements and explanation of most important definitions in detail the individual steps like DQ, IQ, OQ, PQ, calibration and maintenance. The belonging test items are listed together with explanatory examples. Main focus is put on the typical engineering process in case of a new plant and a proposal is made for an integrated plant qualification procedure. Finally the qualification of still existing production plants also is subject of discussion. Key words Qualifizierung • Kalibrierung • Lastenheft • Risikoanalyse • Validierung • Wartung |
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pharmind 2006, Nr. 8, Seite 987
