Good Distribution Practice

Good Distribution Practice

Poster

Maria Krancheva, Jorj Shopov, Emil Hristov, Kalina Andreevska
Faculty of Chemistry and Pharmacy, Sofia University “Saint Kliment Ohridski”, Bulgaria

Wholesale distribution of medicinal products is an important part in integrated supply chain management. Today's drug distribution network is increasingly complex and involves many actors. Good Distribution Practice describes the minimum standards that a wholesaler must meet to ensure that the quality and integrity of medicines are maintained throughout the supply chain. Aim: To acquaint the pharmaceutical community with the regulatory documents and principles of good distribution practice. Methods: We conducted a documentary analysis and an interview with the RP for GDP of a pharmaceutical products’ wholesaler. Results: In 1994, the EU Commission published a guide for Good Distribution Practice. A revised guidance was published in March 2013 to take into account developments in the practice of appropriate storage and distribution of medicinal products in the European Union, as well as the new requirements introduced by Directive 2011/62/E. Good Distribution Practice ensures that medicines are stored, transported – supplied or exported, and treated under the conditions defined by the marketing authorization and medicinal product specifications. Wholesale distributors must maintain a quality system defining the responsibilities, processes and risk management principles associated with their activities. All distribution activities should be clearly defined and systematically reviewed.
Keywords: GDP, guidance