Privatsphäre-Einstellungen

Third Party-Audits: Aspekte von Audit-Gemeinschaften

Dr. Heinrich Prinz a, Dr. Barbara Jentges b und Rudolf Völler c

Biotest AG, Zentrale Qualitätssicherung, Dreieich a, CONCEPT HEIDELBERG, Heidelberg b, und Regierungspräsidium Darmstadt c

Due to the German law „Betriebsverordnung für pharmazeutische Unternehmen“ (Operational Ordinance for Pharmaceutical Entrepreneurs) (. . . ) firms and institutions which commercially produce pharmaceutical products (drugs), control, store, package, distribute or introduce inside the scope of the German law (. . . ) have to as sure that the quality of the pharmaceutical products is fit for the intended use. Beside this the toll manufacture and control as well as the qualification of the supplier for the purchase of starting materials has to be well controlled. Toll manufacturing and control is explicit allowed; the toll-audit for the qualification of the supplier is discussed very controversely. But anyhow, the customer has to make sure that the contractor is going to manufacture and control the pharmaceutical products according to the rules.
In this article the performance of toll-audits, so called Third Party-Audits, for the qualification of the suppliers will be discussed as a possibility to reduce the growing amount of audits. Beside this the already organised Third Party-Audits will be presented.