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Said to be industry’s first for combined EU, USP and WHO standards
World Courier, the AmerisourceBergen express logistics unit that mostly handles clinical trial logistics, has announced that it has garnered Good Distribution Practice (GDP) certification across its global network of 140-plus offices (including 14 depots) in more than 50 countries. Both the worldwide standardization, as well as certification against the GDP standards promulgated by the EU, the Chapter <1079> standards of the US Pharmacopeia, and the GDP standards of the World Health Organization are said to be industry firsts.
"With the increased globalization of supply chains and the emergence of high-value products, such as cell and gene therapies, there is a heightened demand for strict quality and temperature control measures to ensure product quality and integrity throughout long-distance deliveries,” said Sam Herbert, World Courier president, in a statement. “We are proud to be the first specialty logistics provider to achieve this GDP certification on such a global scale.”
It is typical for service providers like World Courier to work with an industry inspection/audit firm to obtain the certification. In this case, World Courier worked with DQS, itself a global registrar with 80 offices in 60 countries.
GDP standards are crucial in commercial shipments of pharmaceuticals, especially in Europe where the standards originated. In general, they call for not only taking measures to ensure the temperature control of shipments, but also to have documentation policies in place for those shipments, and to have designated “Responsible Persons” who are knowledgeable about industry standards and can verify the integrity of those documents. World Courier notes that it also follows relevant Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards where relevant.