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Cover: 9783848493098 | Use of Quality Risk Management for ensuring Good Distribution Practice
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Use of Quality Risk Management for ensuring Good Distribution Practice
Taschenbuch von Adrian Busuttil (u. a.)
Sprache: Englisch

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Beschreibung
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.
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.
Über den 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.
Details
Erscheinungsjahr: 2014
Fachbereich: Toxikologie
Genre: Medizin
Rubrik: Wissenschaften
Medium: Taschenbuch
Inhalt: 272 S.
ISBN-13: 9783848493098
ISBN-10: 3848493098
Sprache: Englisch
Ausstattung / Beilage: Paperback
Einband: Kartoniert / Broschiert
Autor: Busuttil, Adrian
Serracino-Inglott, Anthony
Azzopardi, Lilian M.
Hersteller: LAP LAMBERT Academic Publishing
Maße: 220 x 150 x 17 mm
Von/Mit: Adrian Busuttil (u. a.)
Erscheinungsdatum: 10.10.2014
Gewicht: 0,423 kg
Artikel-ID: 105059740
Über den 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.
Details
Erscheinungsjahr: 2014
Fachbereich: Toxikologie
Genre: Medizin
Rubrik: Wissenschaften
Medium: Taschenbuch
Inhalt: 272 S.
ISBN-13: 9783848493098
ISBN-10: 3848493098
Sprache: Englisch
Ausstattung / Beilage: Paperback
Einband: Kartoniert / Broschiert
Autor: Busuttil, Adrian
Serracino-Inglott, Anthony
Azzopardi, Lilian M.
Hersteller: LAP LAMBERT Academic Publishing
Maße: 220 x 150 x 17 mm
Von/Mit: Adrian Busuttil (u. a.)
Erscheinungsdatum: 10.10.2014
Gewicht: 0,423 kg
Artikel-ID: 105059740
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