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Supply Chain Security – Track & Trace
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Posted: 09/13/2017
risk thumb
Implementing a track and trace program that involves a Contract Manufacturing Organization (CMO) can be hazardous. Andrew Love discusses how to create an airtight roadmap to avoid costly mistakes within serialization. Make sure everyone understands the roadmapAs with all projects, there are two principle aspects of CMO integration that need to Full Content »
Posted: 07/27/2017
Seri report 2017
The end of 2017 is peppered with serialization compliance deadlines for the pharma industry as it continues in the combat against counterfeit medicines. These regions include the likes of Canada, the US, Ukraine and the EU – with the Falsified Medicine Directive’s (FMD) deadline set for early 2018. After these deadlines, in Full Content »
Posted: 07/27/2017
This is the second article in a series looking at how to avoid the supply risk when working with CMOs on serialization. In this article I will discuss another six learnings covering everything from resource-planning to clarifying your RACI.Make sure you have sufficient Plan BsGiven the immature and evolving nature of serialization and the over-stre Full Content »
Posted: 07/14/2017
The FDA has published draft guidance proposing a 12 month grace period on the enforcement of November’s DSCSA ( Drug Supply Chain Security Act) requirements.  Even still the industry should continue serialization projects to secure supply chains ahead of 2017's deadline.The US Food and Drug Administration is planning to postpone taking action Full Content »
Posted: 07/13/2017
rockwell WP
Global pharmaceutical companies lose an estimated $75 billion annually to prescription drug counterfeits — not including costs of diminished brand value. Impending government regulations will require comprehensive serialization elements not just in your manufacturing facilities, but also across the supply chain.The challenges stand tall in ser Full Content »
267 results
of 54