Masterarbeit

Implementation of GDP (2013/C 343/01) - from a logistic supplier's point of view ***

Simone Dietz (2015)

Summary
Language: English
The aim of Good Distribution Practice (GDP) is a secure and legal supply chain in order to maintain the quality and the integrity of medicinal products.
This master thesis provides an overview of the development of the EU-GDP guideline we have today, describes its scope and the practical impact during and after the implementation of the GDP requirements by outlining the major tasks, as well as tasks which are not yet covered. Barriers and benefits of the new GDP requirements are pointed out in a case study from the point of view of a logistics supplier located in Germany. Further, the position of a logistics supplier, its importance to the supply chain and its difficulties in achieving recognition/certification are discussed.
Directive 2011/62/EU on falsified medicines states: "(…) today’s distribution network for medicinal products is increasingly complex and involves many players who are not necessarily wholesale distributors as referred to in that Directive. In order to ensure the reliability of the supply chain, legislation in relation to medicinal products should address all actors in the supply chain."
The trend of outsourcing activities, like transportation and storage of goods, to a logistics service provider is rising. As a consequence, miscellaneous actors are included in the pharmaceutical supply chain. The constellations of involved actors and the influence of the current GDP (2013/C 343/01) for their collaboration shall be illustrated in this thesis.
Pages: 74 plus 1 Annexes with 57 pages