SMART quality & compliance
Same but different – implementation of a track-and-trace serialization of pharmaceuticals in the US
End-to-end vs. Track-and-trace verification The ever-growing threats of illegal (falsified or substandard) pharmaceuticals entering the legal supply chain require specifications of systems effectuating measures to improve patient safety. These are defined by national and / or supranational legislative institutions. The falsified medicines directive by the EU (2011/62/EU, including the Commission Delegated Regulation (EU) 2016/161) requires the implementation of an end-to-end serialization of pharmaceuticals to prevent falsified medicines from entering the legal supply chain (click here to read more on the EU directive). In the US, the Drug Quality and Security Act (DQSA) was signed into law in November 2013. As part of this…
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SMART quality & compliance
Keep Calm and Stay Patient… So Much More Is Coming! -“FDA and the Drug Quality and Security Act”
“Companies spend millions of dollars on firewalls, encryption and secure access devices, and it’s money wasted, because none of these measures address the weakest link in the security chain”. – Kevin Mitnick Drug Quality and Security The problem of counterfeit medicaments and drugs reproduction is one of the major drawback affecting health care systems, patients, and companies worldwide. It is a busting “market” with an estimated worth of 75 billion dollars a year (WHO, 2010). It is fueled by high drugs demand and ease of distribution. Additionally, Internet became a main tool coordinating sales and supply chains of…
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