Use of Quality Risk Management for ensuring Good Distribution Practice

 

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  • Product Description
 

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.

Product Specifications
SKU :COC55046
AuthorAdrian Busuttil,Anthony Serracino-Inglott and Lilian M. Azzopardi
LanguageEnglish
BindingPaperback
Number of Pages272
Publishing Year2014-10-10T00:00:00.000
ISBN9783848493098
Edition1 st
Book TypePharmacology
Country of ManufactureIndia
Product BrandLAP LAMBERT Academic Publishing
Product Packaging InfoBox
In The Box1 Piece
Product First Available On ClickOnCare.com2015-06-08 00:00:00
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