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CPhI-Bericht zeigt Bedarf nach besserer Zertifizierung durch externe Prüfer, um die Wachsamkeit bei GMP zu gewährleisten
Date:7/28/2013

le größerer Bedenken.

Feste Darreichungsformen wie Tabletten und Kapseln dominieren mit 70 % den Markt und Partikelzerkleinerung (60 %) sowie Tablettierung und Kompression (20 %) werden als schwer kontrollierbar eingestuft. Eine Lösung für dieses Problem könnte der zunehmende Einsatz von funktionsübergreifenden Teams sein - wobei 21 % aktiv einstellen und 35 % planen, mehr Materialwissenschaftler einzustellen.

"Materialwissenschaften sind eine gute Ergänzung für die breit angelegte Expertise, die für ein gutes QbD-Konzept nötig ist", erklärte Carlin. Bereits jetzt können wir feststellen, dass die Konzepte PAT und QbD mehr bei Formulierungsprojekten eingesetzt werden und 35 % erklärten, dass sie beide Konzepte nutzen und weitere 36 % planen, sie in naher Zukunft einzusetzen.  

Trotz dieser ermutigenden Zeichen steht Ciurczak der zögernden Haltung der Branche kritisch gegenüber: "65 % der Befragten warten also, ob QbD wirklich funktioniert ... obwohl die Konzepte sich bereits in jeder anderen Branche der Welt bewiesen haben - von Rührgeräten bis hin zu Autos". Doch Carlin weist eine optimistischere Perspektive auf, besonders da das Office of Generic Drugs der FDA zur Annahme des QbD-Konzepts ermutigt. "Die ANDA-Prüfliste wird um QbD-Elemente aktualisiert und daher werden ANDA-Einreichungen zukünftig nicht mehr ohne diese Elemente akzeptiert werden."

Der Bericht schließt, dass der gesamte Markt für pharmazeutische Arznei- und Inhaltsstoffe globaler und wettbewerbsorientierter wird. Mit veränderten gesetzlichen Regelungen werden sich die Arzneimittelhersteller sowie das gesamte Geschäftsumfeld anpassen müssen. "In der EU und in den USA ansässige Unternehmen werden mit ihren Lieferanten zusammen arbeiten
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