Use of Quality Risk Management for ensuring Good Distribution Practice

Language: English

Published by LAP LAMBERT Academic Publishing, 2014

3848493098 / 9783848493098

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Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH

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nach der Bestellung gedruckt Neuware - Printed after ordering - The European Commission introduced Quality Risk Management (QRM) for medicinal product wholesale dealers (MPWD) to ensure Good Distribution Practice (GDP), through the publication of the new EU-GDP guidelines in March 2013. This book serves as a template in the setting up of a QRM system by a MPWD. First, a Quality Management System (QMS) consisting of a number of Standard Operating Procedures (SOPs) regulating each distribution activity is set up. Then medicinal product distribution steps and risks are identified. Finally a QRM exercise is applied to the identified risks. Risks are classified as being acceptable or not acceptable. Corrective and Preventive action is proposed to mitigate unacceptable risks in the distribution of medicinal products. A model Quality Risk Management SOP and a Disaster Recovery SOP are proposed and also presented in this publication.

Seller Inventory # 9783848493098

Title
Use of Quality Risk Management for ensuring Good Distribution Practice
Author
Adrian Busuttil
Publisher
LAP LAMBERT Academic Publishing
Publication year
2014
Condition
Neu
Binding
Taschenbuch
Language
English
ISBN 10
3848493098
ISBN 13
9783848493098
Item weight
423 grams
Dimensions
220x150x17 mm

AHA-BUCH GmbH

Einbeck, Germany

5-star seller

AbeBooks seller since August 14, 2006

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