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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
IPQ Monthly Update – April / May 2016 in Review
In this Update, IPQ explores the complexities and challenges in both the downstream and upstream dimensions of the pharma supply chain. Downstream the IPQ focus continues on the ongoing FDA/industry efforts to implement a comprehensive track & trace system for RX drugs in the US: ● the first story, from the vantage point of FDA and pharma manufacturers ● and the second from that of the wholesalers and distributors. The issue then moves upstream to focus on: ● the divergent ways in which excipients are regulated by agencies around the world ● and how the biotech industry is cooperating to better control the raw materials needed to process and formulate its products.
