£38.59

LAP Lambert Academic Publishing Use of Quality Risk Management for ensuring Good Distribution Practice

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£48.00 £34.65 £37.56 £40.47 £43.39 £46.30 £49.21 23 May 2024 27 October 2024 02 April 2025 06 September 2025 10 February 2026

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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

Format
Paperback
Domain
Amazon UK
Publication Date
10 October 2014
Listed Since
21 October 2014

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