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.
pharmind 2011, Nr. 9, Seite 1588