Privatsphäre-Einstellungen

Inspections by authorities are performed on a regular basis at pharmaceutical manufacturers to assess GMP and regulatory compliance. Such inspections are not only performed by the local authority but also by authorities from foreign countries. Especially inspections by the US Food and Drug Administration (FDA) are of utmost importance for the companies concerned and will lead to considerable additional activities. But FDA inspections can be passed successfully provided that they are prepared thoroughly.
Besides the different types of inspections and their potential consequences this article describes especially the preparation of inspections. Furthermore, the do‘sand-don’t‘s during such inspections are explained and all employees should be trained in this. The advice given for the preparation as well as for the behaviour during inspection is not only applicable for FDA inspections but for inspections by any authority.

Key words FDA • Inspektionen