FDA-gerechte Qualifizierung von Anlagen in der Wirkstoffproduktion
Dipl.-Ing. Ralf Gengenbach
gempex GmbH, Mannheim
FDA-compliant Qualification of Manufacturing Plants for Active Pharmaceutical Ingredients
Qualification of pharmaceutical production plants nowadays being an essential quality assurance element is urgently required in the GMP (Good Manufacturing Practice) regulations. But nevertheless, many people still do not know exactly how to proceed, especially how to incorporate the various activities in the planning and building of intricate plants. The following article, after dealing briefly with regulatory requirements and explaining the most important terminology, depicts the individual steps such as DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), calibration, and maintenance in detail. The corresponding test items are listed and illustrated with the aid of specific examples. The article particularly focusses on the typical process performed for new plants, and shows a way to integrated plant qualification. Finally, qualification of already existing production plants is also described briefly.
Key words Anlagen-Qualifizierung · Qualitätssicherung · Validierung · Wirkstoffproduktion
pharmind 2003, Nr. 7, Seite 704