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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

nahe, dass ein Bedarf danach besteht, zu Lieferanten zu wechseln, die mehr auf die Pharmabranche ausgerichtet sind."

Tatsächlich waren sich die Hälfte der Befragten einig, dass die Qualität eines der wichtigsten Themen sei, wobei 41 % hinzufügten, dass die Lieferung eines der größten Probleme bei Arzneistoffen und Inhaltsstoffen sei. Doch laut Carlin können Qualitätsprobleme möglicherweise nicht nur auf fehlende Zertifizierungen von Inhaltsstoffen zurückgeführt werden: "Falls eine uneinheitliche Qualität aufgrund unbekannten Arzneiträgereigenschaften vorliegt, dann kann ein Teil des Problems, neben der Zertifizierung von Analysen, auch auf inadäquatem Feedback für die Lieferanten beruhen."

Die Auslagerung ist ein weithin anerkannter, großer Trend in der gesamten Branche, und doch arbeitet nur etwas mehr als ein Drittel in der Branche derzeit mit CMOs und CDMOs zusammen. Dies spiegelt möglicherweise ein zögerliches Verhalten bei der Auslagerung der Entwicklung von neuen chemischen Stoffen aus Angst vor potenziellen Verstößen gegen das geistige Eigentumsrecht wieder. Doch trotzdem vergeben bereits über die Hälfte der Befragten klinische Studien an CROs und nahezu 40 % arbeiten aktuell bei der Entwicklung mit akademischen Gruppen zusammen.

Die größten Probleme bei Formulierungen entstehen laut der Umfrageteilnehmer aufgrund neuer Wirkstoffziele, die komplexer werden und Löslichkeitsprobleme sowie ein schlechtes Freisetzungsprofil aufweisen. Mehr als zwei Drittel der Befragten aus der Pharmabranche erwähnten, dass die "Bioverfügbarkeit" und die "Stabilität" derzeit dringende Probleme in der Branche darstellten. Auch das "Auflösungs-" und "Freisetzungs"-Profil sind für über die Hälfte der Befragten der Branche Quel
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