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Einführung eines QM-Systems nach DIN EN ISO 9001:2000 und DIN EN ISO 13485:2003 in einem mittelständischen GMP-Betrieb

Dipl.-Ing. BPT Tom Jünemann¹, Andreas Reeg¹, Dr. Jörg Amborn², Richard Engelhard¹ und Prof. Dr. Frank Runkel³

Engelhard Arzneimittel GmbH & Co. KG¹, Niederdorfelden, Dade Behring GmbH², Marburg, und
Institut für Biopharmazeutische Technologie, Fachhochschule Gießen-Friedberg³

The ICH Q10-guideline has been released as step 3. The guideline describes a pharmaceutical quality system, which includes GMP and ISO systems. This article explains the certification process of a GMP-certified company in compliance with DIN EN ISO 9001: 2000 and DIN EN ISO 13485:2003 standards. The phases of the certification process are described and specific differences or commonalities of the single standards are illustrated.