Allgemein, News
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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Allgemein, News
Better Prepared with a Health Check ?
CC BY-SA 3.0 NY “By failing to prepare, you are preparing to fail”. – Benjamin Franklin FDA published an announcement in August 2016 to focus on part 11 inspections in near future. The future is now. Project tollgates, health checks, periodic reviews, assessments, audits, real time monitoring. What is the best way to always be prepared and ready for Health Authority inspections? Computerized systems and projects vary in size and complexity ranging from few users by supporting a simple business process to thousands of users supporting multiple business processes. Furthermore, projects can range from single location to a global rollout…
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Allgemein
Patient safety first – a new EU directive to protect public health from falsified medicines
By Asemi – By our camera, CC BY-SA 3.0, Link “It is health that is real wealth and not pieces of gold and silver.” Mahatma Gandhi Imagine you have a bacterial infection and require therapy using antibiotics. Instead of obtaining the antibiotics and dosage you require, you receive substandard or falsified medicine, which for various reasons does not ease your infection or has previously non-described side effects on your health. While you might feel like this is a cautionary tale to raise your awareness for the fact that falsified medicines exist, this is a real-life problem which has become more…
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