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GMP- gerechte Validierung/Qualifizierung & Dokumentation: Auflage II mit praxisnahen Fallbeispielen, Templates und Pharma-Wörterbuch
Paperback
Publisher: Independently Published
Published: Mar 10 2026
Pages: 278
Weight: 1.07
Height: 0.58 Width: 7.00 Depth: 10.00
Language: German
Dieses Buch wurde geschrieben, um diese Lücke zwischen der Theorie der Verordnungen und der Praxis im Projektalltag zu schlie en.
Was Sie in diesem Buch erwartet:
Teil 1: Das Fundament. Wir betrachten die essenziellen Anforderungen der Guten Herstellungspraxis (GMP) und der Guten Dokumentationspraxis (GDP). Von der URS über die FMEA bis hin zum klassischen V-Modell (DQ, IQ, OQ, PQ) werden alle Phasen detailliert erläutert.
Teil 2 & 3: Die Anwendung. Graue Theorie hilft nur bedingt. Deshalb widmet sich ein gro er Teil dieses Werkes einer umfassenden Fallstudie. Wir begleiten ein fiktives, aber realitätsnahes Projekt von der ersten Risikoanalyse bis zu den Templates für IQ, OQ und PQ.
Teil 4: Der Abschluss. Der Prozess endet nicht mit dem Testlauf und Abschlussbericht. Wir schauen uns an, wie Berichte für Qualifizierungsplan und Validierungs-Masterplan professionell verfasst werden und wie das Change Control Verfahren den validierten Status langfristig sichert.
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