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Use of Quality Risk Management for ensuring Good Distribution Practice

 
9783848493098: Use of Quality Risk Management for ensuring Good Distribution Practice
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Reseña del editor:

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.

Biografía del autor:

Adrian Busuttil graduated in 2004 and has 10 years experience working in community pharmacy, medicinal products manufacture and wholesale dealing. He completed a Master of Science degree in Pharmacy in 2013. Anthony Serracino-Inglott is Professor and Lilian M. Azzopardi is Professor and Head of Department of Pharmacy at the University of Malta.

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Adrian Busuttil
Verlag: LAP Lambert Academic Publishing (2014)
ISBN 10: 3848493098 ISBN 13: 9783848493098
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Buchbeschreibung Taschenbuch. Zustand: Neu. Druck auf Anfrage Neuware - 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. 272 pp. Englisch. Artikel-Nr. 9783848493098

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