Use of Quality Risk Management for ensuring Good Distribution Practice - Couverture souple

Busuttil, Adrian; Serracino-Inglott, Anthony; Azzopardi, Lilian M.

 
9783848493098: Use of Quality Risk Management for ensuring Good Distribution Practice
Couverture souple
ISBN 10 : 3848493098 ISBN 13 : 9783848493098
Editeur : LAP LAMBERT Academic Publishing, 2014

Synopsis

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.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Présentation de l'éditeur

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.

Biographie de l'auteur

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.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
LAP LAMBERT Academic Publishing
Date d'édition
2014
Langue
anglais
ISBN 10 
3848493098
ISBN 13 
9783848493098
Reliure
Broché
Nombre de pages
272
Coordonnées du fabricant
non disponible
Personne responsable
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