Bookcover of Use of Quality Risk Management for ensuring Good Distribution Practice
Booktitle:

Use of Quality Risk Management for ensuring Good Distribution Practice

LAP LAMBERT Academic Publishing (2014-10-10 )

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ISBN-13:

978-3-8484-9309-8

ISBN-10:
3848493098
EAN:
9783848493098
Book language:
English
Blurb/Shorttext:
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.
Publishing house:
LAP LAMBERT Academic Publishing
Website:
https://www.lap-publishing.com/
By (author) :
Adrian Busuttil, Anthony Serracino-Inglott, Lilian M. Azzopardi
Number of pages:
272
Published at:
2014-10-10
Stock:
Available
Category:
Pharmacy
Price:
59.90 €
Keywords:
quality risk management, medicinal products, good distribution practice, wholesale dealing

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