In this environment, the distribution and transport of medicines and active ingredients (APIs) for human use are key supply chain activities that must be controlled in order to maintain the quality and integrity of the medicines, as set forth in the European regulations, 2011/62/EU and related Guides 2013/C 343/01 and 2015/C 95/01, as well as current FDA initiatives and expectations.
How to identify all the actors involved in the supply chain?
What controls should be established along the supply chain?
Who should have a GDP certificate for the distribution or transport of medicines?
What is a GDP certificate and who can issue it?
How responsibilities along the supply chain should be defined?
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