Privatsphäre-Einstellungen

Planung und Durchführung von Audits in Europa, Asien und Südamerika

Teil 1

Dr. Christian Hösch

Behörde für Soziales, Familie, Gesundheit und Verbraucherschutz, Hamburg

Corresponding author: Dr. Christian Hösch, Behörde für Soziales, Familie, Gesundheit und Verbraucherschutz, Fachabteilung für Patientenschutz und Sicherheit in der Medizin, Billstr. 80, 20539 Hamburg (Germany); e-mail: christian.hoesch@bsg.hamburg.de

Preparation and Performance of Audits in Europe, Asia and South America

Harmonised GMP-guidelines have contributed to the globalisation of markets for medicinal products and APIs. Audits of the manufacturer abroad, performed by the pharmaceutical industrie or drug surveillance authorities, are an important tool to ensure quality. The performance of audits in foreign countries is a special challenge for auditors: The success is based on a careful preparation. Organisation, suitable expertise and an individually planed audit schedule are a must.
Language problems should be addressed in advance, including the translation of important documents. At least three days of inspection are needed for an audit abroad; a running production must be ensured.
Special points of interest for audits abroad and typical findings in warehouses, production, quality control and quality assurance are described from the point of view of a GMP-inspector. It is important to inspect all rooms during the audit. Correlation of documentation with the actual sequence of operations, compliance to quality specifications and handling of deviations should be of special focus.
There are two critical issues concerning API manufacturers: additional purchases of APIs from unknown third parties and the production of different API qualities. Strategies are outlined to address these issues. Finally, some cultural particularities are described, which are helpful to know for audits abroad.

Key words Arzneimittel • Asien • Audit • Globalisierung • GMP-Inspektion • Wirkstoffe