Pharmaceutical Supply Chain Security & Integrity (2016) 

Pharmaceutical supply chains are becoming more and more complex due to globalization, shift of manufacturing and business operations to Asia, and due to complex relationships between vendors and supply chain partners. Good distribution practices are an important part of the whole system of appropriate supply chain management. Recently introduced legislation in the U.S. and in Europe brings major changes in the management of pharmaceutical supply chains, increasing the level of control over all parts of the process, eventually leading to the creation of repositories, complex identification and authentication systems, and introduction of interoperable track-and-trace systems. Introductory chapter outlines regulations and guidelines that govern the industry in the U.S., European Union, and in major Asian economies such as Japan, India and China. Russia is included to explain its unique approach to pharmaceutical supply chain security. Differences between major markets and jurisdictions include lack of consensus on the definition of counterfeit, misbranded, adulterated or falsified drug, thresholds for their detection, identification requirements, and track-and-trace methods and obligations.

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