Privatsphäre-Einstellungen

Praktische Aspekte der Vorbereitung, Begleitung und Nachbereitung von Inspektionen der FDA, anderer Behörden und Kundenaudits

Dr. Jörg Fetsch

Haema AG, Berlin

Practical Aspects of the Preparation, Escort and Follow-up of Inspections by the FDA, Other Authorities and Customer Audits

Inspections by authorities are performed on a regular basis at pharmaceutical manufacturers to assess the 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. 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 dos-and-donts during such inspections are explained and all employees should be trained in this.
One chapter focuses on inspections by German authorities.
The advice given for the preparation as well as for the behaviour during the inspection is not only applicable to FDA inspections but to inspections by any authority and also to customer audits.
Several examples from the personal experience of the author as auditor and escort of inspections should help to understand the rules during authority inspections and customer audits.