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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

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Der Bericht spiegelt die Bedenken der Regulierungsbehörden (FDA, EMA) wider, welche von diesen in Hinblick auf die Notwendigkeit von externen Prüfern zur Gewährleistung der Sicherheit und der Qualität der Anlagen für Arzneistoffen und Inhaltsstoffen geäußert wurden. Nahezu 95 % der Befragten stimmten zu, dass die Zertifizierung der Lieferanten ein wichtiger Faktor sei, und doch arbeiteten weniger als ein Viertel aktiv mit externen Prüfern zur Überprüfung von Lieferanten zusammen. Hierdurch wird nahegelegt, dass eine größere Wachsamkeit für ein Problem nötig ist, dass die Branche weiterhin meidet.

Von denen, die mit Dritten zusammenarbeiten, antworteten nahezu 31 %, dass sie mit dem Verified Ingredients Program von USP arbeiten; 18 % nutzen EXCIPACT; und 10 % nutzen entweder IPEC beziehungsweise APIC.

Laut Girish Malhotra, CPhI-Branchenexperte und Gremiumsmitglied könne die Untätigkeit in der Branche auf eine schlechte interne Kommunikation sowie auch auf eine schlechte Kommunikation mit den Lieferanten zurückgeführt werden. "Wenn die Lieferantenstandorte besucht werden, dann müssen die Herstellungs- und Analysepraktiken bekannt sein und sowohl Lieferanten als auch Käufer müssen bezüglich der benötigten Zertifizierungen übereinstimmen. Es dürfen keine Abkürzungen genommen werden!"

Gremiumskollegen schlossen sich dieser Sichtweise an. Emil Ciurczak kommentierte: "Es gibt Inkonsistenzen, da wir in Silos arbeiten". Brian Carlin wiederholte diese Einstellung und fügte hinzu: "Die Kombination aus Bedenken bezüglich der Qualität, der Lieferung und dem fehlenden Verständnis legen
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