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It’s impossible to read an article today whether it is related to food safety and transportation, or even the drug supply chain, without seeing a mention of Block Chain somewhere on the page, or within the article. It is almost like a new era for the Internet and any other data “carrier” service, but we are assured by the “experts” that it will power the Internet of Things (IOT), and potentially will open doors to many other logistics services applications.
By Peter Norton
Author: Peter Norton
Peter Norton is currently employed as the Business Development Director for DeltaTrak Inc., of Pleasanton CA. His primary areas of expertise relate to Cold Chain and Supply Chain Logistics Solutions, for which he advises clients on processes related to Cold Chain shipping solutions, Risk Assessment, Inventory Management and the emerging new rules and regulations for Cold Chain linked into Track and Trace and e-Pedigree.
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As the regulations for food and pharma' get closer together in nature an overarching guidance is emerging which is related to risk aversion and risk mitigation planning.
When we use the word Smart and couple this with Solutions, then add in the term Last Mile, or Patient Mile, it seems everything you read has either a different solution, or interpretation related to the need!
The ICH and other globally focused organizations are working diligently to introduce more consolidated forms of quality regulations, like the ICH Q10, for the management of the quality of drugs related to cold chain distribution and drug security.
According to FDA Commissioner Margaret Hamburg, “Nearly 40 percent of the drugs Americans take are imported, and nearly 80 percent of the active ingredients in the drugs in the American market come from overseas sources.” The World Health Organization estimates that "Of the approximately 4 billion prescriptions written in the U.S. in 2011, 40 million were likely fraudulent."
It goes without saying – but I’ll say it anyway – the longer the shipping duration is for temperature sensitive commodities, the stricter the requirements become when choosing the right data logger. Longer transportation times yield a broader chance for mishaps to arise during the trip. That’s why DeltaTrak has specially designed a temperature monitoring device you can trust; one that has a long battery life; one that will go on and on - sort of like that crazy rabbit on TV.
Today there is an ever growing trend toward Cloud Computing, with many companies entrusting their data to an outsourced agency. As we approach the New Year, it seems like a good time to review all areas of your supply chain where risks might exist, and to mitigate these issues with risk aversion planning that will meet GDP compliance.
Late last month the FDA CBER (Consumer Affairs Branch) issued an advisor notice to interested persons containing information related to the storage and use of temperature sensitive biological products that have been involved in a temporary electrical power failure, or flood conditions.
On November 27th of 2013 when President Obama signed into law the HR3204 - the Drug Quality and Security Act, it was the result of many years of discussion and past attempts to establish a US centric law based upon securing the drug supply chain in an effort to prevent the entry of falsified medicinal products into the supply chain.