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Mitigating Serialization and Traceability, a Study on the Strategies for the Implementation of the System and Adaptation to the TBR n$${^\mathrm{o}}.$$ 54 2013

Abstract : Following a worldwide trend, Brazil is regulating control actions and traceability of medicines Through Board Resolution (TBR) n$${^\mathrm{o}}$$. 54, which provides for the establishment of the national system drug control and the mechanisms and precedents for your tracking in the chain of pharmaceuticals. Depending on the responsibility to ensure, ensure the maintenance, enhance quality, promote the safety and efficacy of products to the final consumer and seeking to avoid the risks and adverse health effects, companies, factures or importers, have a responsibility to adopt mechanisms and procedures that address is resolution. This article presents an overview of the needs of serialization and traceability pharma-protection products, as well as value creation opportunities in the implementation of systems and their adequacy to rules for companies that make up the cahate pharmaceutical value.
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André Lira Muniz, Debora Correa, Jair Abe, Fábio Do Amaral, Lauro Tomiatti. Mitigating Serialization and Traceability, a Study on the Strategies for the Implementation of the System and Adaptation to the TBR n$${^\mathrm{o}}.$$ 54 2013. IFIP International Conference on Advances in Production Management Systems (APMS), Sep 2016, Iguassu Falls, Brazil. pp.445-451, ⟨10.1007/978-3-319-51133-7_53⟩. ⟨hal-01615786⟩

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