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Taschenbuch. Condition: Neu. Use of Quality Risk Management for ensuring Good Distribution Practice | Adrian Busuttil (u. a.) | Taschenbuch | 272 S. | Englisch | 2014 | LAP LAMBERT Academic Publishing | EAN 9783848493098 | Verantwortliche Person für die EU: OmniScriptum GmbH & Co. KG, Bahnhofstr. 28, 66111 Saarbrücken, info[at]akademikerverlag[dot]de | Anbieter: preigu.
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Published by LAP Lambert Academic Publishing, 2014
ISBN 10: 3848493098 ISBN 13: 9783848493098
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Published by LAP LAMBERT Academic Publishing, 2014
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Published by LAP LAMBERT Academic Publishing Okt 2014, 2014
ISBN 10: 3848493098 ISBN 13: 9783848493098
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Taschenbuch. Condition: Neu. This item is printed on demand - it takes 3-4 days longer - 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.
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Published by LAP LAMBERT Academic Publishing, 2014
ISBN 10: 3848493098 ISBN 13: 9783848493098
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Condition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Autor/Autorin: Busuttil AdrianAdrian 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 Se.
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Published by LAP LAMBERT Academic Publishing Okt 2014, 2014
ISBN 10: 3848493098 ISBN 13: 9783848493098
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Taschenbuch. Condition: Neu. This item is printed on demand - Print on Demand Titel. 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.VDM Verlag, Dudweiler Landstraße 99, 66123 Saarbrücken 272 pp. Englisch.
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Published by LAP LAMBERT Academic Publishing, 2014
ISBN 10: 3848493098 ISBN 13: 9783848493098
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Taschenbuch. Condition: Neu. 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.