EU Good Distribution Practices (GDP) Guideline of Medicinal Products for Human Use finalized
After public consultation in 2011 and further adjustment in 2012 the new version of the EU GDP Guideline of Medicinal Products for Human Use has been finalized and published in the Official Journal of the European Union (08.03.2013).
Besides ensuring compliance with Good Manufacturing Practices (GMP) participants of the pharmaceutical supply chain need to increasingly focus also on adherence to GDP principles in order to ensure appropriate product quality from the manufacturer to the (end-) user. These requirements have inter alia been strengthened by related changes promulgated by Directive 2011/62/EC.
The following bullet points summarize the current status of GDP guidelines for Medicinal products, APIs and excipients on a global level and provide the related links to the documents: