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Pharmazeutische Produkte und Verfahren

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Year: 2007

Publisher: Weinheim, Wiley-VCH

Media group: Ausleihbestand

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Branch	Locations	Status	Reservations	Due date	Barcode	Floor plan	Lending note
Branch: Hauptstelle	Locations: ME-30 86 / Band fehlt o. Nachweis	Status: borrowed	Reservations: 0	Due date: 4/4/2012	Barcode: 00190560	Floor plans: Floor plan	Lending note:

Content

Kurzbeschreibung

Dieses Buch bietet einen umfassenden Überblick über die Anforderungen an pharmazeutische Produkte und Herstellungsverfahren. Es beschreibt detailliert die Prozesse, Produktionstechniken und -anlagen sowie die begleitenden Qualifizierungs- und Validierungsmaßnahmen.

Aus dem Inhalt

Einführung

Arzneiformen, Arzneimittel, Good Manufacturing Practices und Qualität

-Arneimittelrecht

-Arzneibuch

-Good Manufacturing Practices (GMP)

-Arzneiformen im Überblick

-Pharmazeutische Entwicklung

-Qualitätssicherung der industriellen Produktion

Anforderungen an Produktionsanlagen und deren Betrieb

-Grundlegende Begriffe und Konzepte der Qualitätssicherung

-Qualifizierung

-Prozessvalidierung

-Risikoanalyse

-Reinigungsvalidierung

-Computervalidierung

-Produktionsanlagen

-Anlagen- und Arbeitssicherheit

-Reinraumtechnik, Barrieretechniken und Isolatortechnik

-Produktion steriler Arzneiformen

-Herstellung und Verteilung von pharmazeutischem Reinstdampf

-Messdatenerfassung und statistische Datenanalyse

Pharmazeutische Produktionsprozesses für ausgewählte Arzneiformen

-Zerkleinerungsmaschinen und Mühlen

-Produktion fester Arzneiformen

-Produktion flüssiger und halbfester Arzneiformen

-Produkte steriler und aseptischer Arzneiformen

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Details

Statement of Responsibility: herausgegeben von Gerd Kutz und Armin Wolff

Year: 2007

Publisher: Weinheim, Wiley-VCH

Classification: ME-30

Subject type: Handbücher

ISBN: 9783527312221

ISBN (2nd): 3-527-31222-6

Description: XVII, 445 S. : Ill., graph. Darst.

Tags: Pharmazie

Participating parties: Kutz, Gerd [Hrsg.]; Wolff, Armin [Hrsg.]

Footnote: Literaturangaben

Media group: Ausleihbestand

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