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Integriertes Konzept für Engineering und Qualifizierung von Apparaten und Ausrüstungsgegenständen

Barbara Vidiere

LSMW GmbH, Stuttgart

Integrated Concept for Engineering and Qualification of Apparatus and Equipments

The following article demonstrates how costs and time expenditure can be saved using integrated planning and implementation for engineering and qualification services concerning installations in the pharmaceutical industry. The integrated approach aims at:

- detection of faults in the design or construction using measures of quality assurance at an early state of the project in order to avoid large-scale actions for the removal of faults at a late project state with lack of time.

- documentation of quality assurance measures implemented according to Good Engineering Practice in a way that these measures may serve as part of the qualification to reduce the expenditure for qualification.

- the implementation of current GMP/ FDA requirements.

Key Words Pharma-Anlagen, Ausführung, Inbetriebnahme, integriertes Konzept, Planung, Qualifizierung