Use of Quality Risk Management for ensuring Good Distribution Practice
Language: English
Published by LAP LAMBERT Academic Publishing Okt 2014, 2014
- Softcover
- New
Seller: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, GermanyBuchWeltWeit Ludwig Meier e.K.
AbeBooks seller since January 11, 2012
Condition: New
£ 52.88
Quantity: 2 available
Add to basketItem description from seller
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.
Seller Inventory # 9783848493098
- Title
- Use of Quality Risk Management for ensuring Good Distribution Practice
- Author
- Adrian Busuttil
- Publisher
- LAP LAMBERT Academic Publishing Okt 2014
- Publication year
- 2014
- Condition
- Neu
- Binding
- Taschenbuch
- Language
- English
- ISBN 10
- 3848493098
- ISBN 13
- 9783848493098
- Item weight
- 423 grams
- Dimensions
- 220x150x17 mm
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About the Author
"About the title" may belong to another edition of this title.
BuchWeltWeit Ludwig Meier e.K.
Bergisch Gladbach, Germany
AbeBooks seller since January 11, 2012
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BuchWeltWeit Ludwig Meier e.K.
Germany
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