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Abweichungsmanagement in Der Pharmazeutischen Industrie by Patric U. B. Vogel

Abweichungsmanagement in Der Pharmazeutischen Industrie

by Patric U. B. Vogel
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Book cover type: Paperback
  • ISBN13: 9783662668917
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Springer Spektrum
  • Publisher Imprint: Springer Spektrum
  • Publication Date:
  • Pages: 53
  • Original Price: EUR 14.01
  • Language: German
  • Edition: 1. Aufl. 2023
  • Item Weight: 87 grams
  • BISAC Subject(s): Pharmacology

Das Abweichungsmanagement ist eines von vielen Qualitätssystemen in pharmazeutischen Unternehmen. Der pharmazeutische Prozess, von der Beschaffung von Ausgangsstoffen bis zur Fertigung des Endprodukts, erfolgt über Wochen und teils Monate gemä schriftlichen Arbeitsanweisungen, deren korrekte Ausführung eine konsistente Produktqualität sicherstellen. Bei all diesen Schritten können unerwartet Abweichungen von den festgelegten Prozeduren auftreten. Diese müssen dokumentiert und hinsichtlich des möglichen Einflusses auf die Produktqualität und die Patientensicherheit bewertet werden. Weiterhin sollte die Ursache für die Abweichung identifiziert werden, um die Fehlerquelle durch geeignete Ma nahmen abstellen zu können. Regelmä ige Trendanalysen wichtiger Kennzahlen helfen ferner, die Situation bei Abweichungen zu überwachen.

Patric U. B. Vogel ist Biologe und war in verschiedenen Abteilungen (u.a. Qualitätskontrolle und Qualitätssicherung) tätig, u.a. auch als Experte für Risiko- und Ursachenanalysen bei Abweichungen, und ist im pharmazeutischen Bereich selbstständig.

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