Ankündigung Erscheint vsl. Juni 2019 Abbildung von Ostrove | Equipment Qualification in the Pharmaceutical Industry | 2019

Ostrove

Equipment Qualification in the Pharmaceutical Industry

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ca. 116,63 €

inkl. Mwst.

2019. Buch. 234 S. Softcover

William Andrew Publishing. ISBN 978-0-12-817568-2

Format (B x L): 15,2 x 22,9 cm

In englischer Sprache

Das Werk ist Teil der Reihe: Aspects of Pharmaceutical Manufacturing

Produktbeschreibung

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems.

Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols.



- Incorporates good manufacturing processes into a compliant qualification program
- Provides examples of protocol layout
- Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements

Gesamtwerk

Die 8. Auflage ist wieder auf sechs Bände angelegt. Darin finden sich übersichtlich und in systematischer Gliederung Vertragsmuster aus der Feder erfahrener Experten. Jedem dieser Muster folgen Anmerkungen, mit denen der dem Vertragsentwurf zu Grunde liegende Sachverhalt und die Gründe für die Wahl des spezifischen Formulars erläutert werden.

Autoren

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