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GMP-Basis: Grundwissen für alle Mitarbeiter in der Produktion, Quality Management
Paperback
Publisher: Independently Published
Published: Mar 19 2024
Pages: 222
Weight: 0.58
Height: 0.47 Width: 5.50 Depth: 8.50
Language: German
Die Good Manufacturing Practice (EU-GMP) bildet die Grundlage für die sichere Herstellung pharmazeutischer Produkte. Doch gerade für Berufseinsteiger, Auszubildende, Studierende und Quereinsteiger wirken die zahlreichen Vorschriften, Fachbegriffe und Prozesse oft komplex und schwer verständlich.
Dieses Buch vermittelt die wichtigsten Grundlagen der pharmazeutischen Produktion Schritt für Schritt - verständlich, praxisnah und mit zahlreichen Beispielen aus dem Arbeitsalltag.
Sie erfahren unter anderem:
- wie das EU-GMP-Regelwerk aufgebaut ist und welche Anforderungen erfüllt werden müssen,
- welche Bedeutung GMP-Dokumentation (GDP), SOPs und Batch Records in der Praxis haben,
- wie Reinräume funktionieren und welche Anforderungen an Personal, Bekleidung und Hygiene gestellt werden,
- wie Qualifizierung, Monitoring, HVAC-Systeme sowie Reinraumklassifizierungen zusammenwirken,
- wie pharmazeutische Produkte hergestellt werden - von der Rohstoffverwiegung über Mischprozesse bis hin zu Tabletten, Salben, Pulvern und sterilen Injektionslösungen,
- welche Rolle Qualitätsmanagement, Risikomanagement und kontinuierliche Verbesserung in modernen Pharmaunternehmen spielen,
- sowie ein umfangreiches Pharmatechnik-Wörterbuch zum schnellen Nachschlagen wichtiger Fachbegriffe.
Das Buch verbindet theoretisches Wissen mit praxisnahen Erläuterungen und unterstützt Sie dabei, GMP-Anforderungen sicher zu verstehen und im Berufsalltag anzuwenden.
Ideal für:
- Mitarbeiter in der pharmazeutischen Industrie
- Berufseinsteiger und Quereinsteiger
- Auszubildende und Studierende
- Produktions-, Qualitäts- und Reinraumpersonal
- Teilnehmer von GMP-Schulungen und Weiterbildungen
Egal, ob Sie sich auf den Einstieg in die Pharmaindustrie vorbereiten oder Ihr bestehendes Wissen vertiefen möchten - dieses Buch bietet Ihnen einen umfassenden und leicht verständlichen Einstieg in die Welt der EU-GMP.
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