Entwicklung und Bedeutung des ISO-GMP-Standards DIN EN ISO 15378 Titel der Norm: Primärpackmittel für Arzneimittel − Besondere Anforderungen für die Anwendung von ISO 9001:2000 entsprechend der Guten Herstellungspraxis (GMP) Peter A. Schröder MGlas AG (MG), Münnerstadt Korrespondenz: Dr. Peter A. Schröder, Projekt D2F® Pharmazeutischer Leiter, Otto-Liebmann-Str. 2, 97702 Münnerstadt (Germany), e-mail: ps@mglas.de Development and Significance of the ISO GMP Standard DIN EN ISO 15378 ISO 15378:2006 was published by the ISO Central Secretariat (Geneva, Switzerland) on 1 March 2006. After many years, the standard closes the delta between ISO 9001:2000 and GMP for the manufacture of primary packaging materials. Its significance for the pharmaceutical industry in Germany has been increasing, in particular since the German AMWHV defining requirements on packaging materials and supplier qualification has taken effect. DIN EN ISO 15378 will replace ISO 9001:2000 for pharmaceutical primary packaging materials. In addition, the demand for certification based on ISO 15378:2006 has also skyrocketed beyond Germany. Key words AMWHV • Good Manufacturing Practice (GMP) • DIN EN ISO 15378 • ISO-GMP-Standard für Primärpackmittel 15378 • Lieferantenqualifizierung • Parenteralia • Primärpackmittel |
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pharmind 2007, Nr. 8, Seite 969
