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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

AMSTERDAM, July 28, 2013 /PRNewswire/ --


- Die Konzepte QbD und PAT werden derzeit nur von einem Drittel der Branche genutzt

- Erkenntnisse von CPhI Pharma: Bericht über Formulierung und Inhaltsstoffe

Highlights des Berichts:

  • Partikelzerkleinerung stellt für 60 % der Befragten der Branche bei der Formulierung eine große Herausforderung dar
  • Bioverfügbarkeit weiterhin eine große Herausforderung bei der Formulierung - zwei Drittel benennen es als deren dringendstes Problem
  • Indien und China führend als Quellen für Arzneistoffe (API - Active Pharmaceutical Ingredient)
    • Doch Qualität ist weiterhin für die Hälfte der Befragten der Branche das größte Problem bei APIs und Inhaltsstoffen
  • Mehr als die Hälfte der Befragten vergeben die klinische Arbeit an Auftragsunternehmen für die Forschung (CRO - Contract Research Organisation)
  • Bei der Entwicklung von neuen Wirkstoffen werden Auftragsunternehmen für die Herstellung (CMO - Contract Manufacturing Organization) und Auftragsunternehmen für die Entwicklung und für die Herstellung (CDMO - Contract Development and Manufacturing Organization) weiterhin nur zögerlich genutzt
  • Akademische Partnerschaften nehmen zu und 40 % der Befragten arbeiten mit diesen

CPhI Worldwide und CPhI Pharma Evolution, teil des pharmazeutischen Portfolios von UBM Live, gaben die Ergebnisse ihres ersten monatlichen Berichts über den aktuellen Status des Markts für Formulierungen und Inhaltsstoffe bekannt, für den innerhalb des letzten Monats oberste Führungskräfte sowie Experten aus der Branche befragt wurden.


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SOURCE UBM Live
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