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GMP-Qualifizierung und Validierung von Wirkstoffanlagen by Ralf Gengenbach

GMP-Qualifizierung und Validierung von Wirkstoffanlagen

by Ralf Gengenbach
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Book cover type: Hardcover
  • ISBN13: 9783527307944
  • Binding: Hardcover
  • Subject: N/A
  • Publisher: Wiley-Vch
  • Publisher Imprint: Wiley-Vch
  • Publication Date:
  • Pages: 492
  • Original Price: GBP 175.0
  • Language: German
  • Edition: N/A
  • Item Weight: 985 grams
  • BISAC Subject(s): Chemical & Biochemical

Unter Validierung bzw. Qualifizierung versteht man die Beweisführung, dass Verfahren, Prozesse, Ausrüstungsgegenstände, Materialien, Arbeitsgänge oder Systeme tatsächlich zu den erwarteten Ergebnissen führen. Betroffen sind alle Unternehmen, die Rohstoffe, Halbfertig- oder Fertigprodukte für medizinische Geräte, Pharmazeutika, Diagnostika, Lebensmittel herstellen. Ebenso sind Labore betroffen, die Dienstleistungen anbieten, deren Ergebnisse direkt in den Herstellungsprozess einflie en.

Dieses Buch liefert "harte Fakten" hinsichtlich der Durchführung (How to do) von praxiserprobten Qualifizierungs- und Validierungsma nahmen - ein "Must have" für Wirkstoff- und Arzneimittelhersteller sowie deren Zulieferer.

Der deutsche Titel zur Validierung und Qualifizierung

Dipl.-Chemieingenieur
1981 - 1987, TU Karlsruhe

BASF AG (1987 - 1997)
Verfahrensentwicklung biotechnologisch hergestellter Wirkstoffe,
Betriebsbetreuung Biotechnikum A30 Projektingenieur, Planung, Bau und Umbau von GMP-gerechten Anlagen einschliesslich WFI-, VEW-, Reindampf-, Druckversorgungseinrichtungen
Obmann des GMP Fachreferates Technik
- bereichsübergreifende GMP-Beratung
- Inspektionsbegleitung

DIS AG (1997 - 2002)
Leiter Bereich Quality Consult, Niederlassung Mannheim
Seit 2002 Geschäftsführer der gempex GmbH

Mitgliedschaften / Qualifikation
DIN UA2, Normung im Bereich Biotechnologie
DECHEMA AK "Validierung"
Ausgebildeter Qualitätsauditor
Verein Interessengemeinschaft Pharmabau 3000 - VIP 3000

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