European Union Good Distribution Practices for Medicinal Products

<p>This course describes the Good Distribution Practices required by the European Union (EU). The EU’s recommended practices are similar to requirements in the US and many other countries. The controls to maintain the quality and integrity of medicinal products as they are distributed from manufacturer to patient are explained in this course. Because modern supply chains are often complex, the responsibilities of all organisations involved with wholesale activities — including storage, transport, purchase, and supply — are detailed. The controls required to prevent falsified or fake products entering the supply chain are also addressed.</p>

After this course learners will be able to identify the eu requirements for maintaining product quality and integrity at each stage in the distribution process as defined in directive 2001/83/ec and revised guidelines 2013/c 343/01. identify the documentation required and the responsibilities for achieving and maintaining ongoing compliance with the eu gdp requirements.