Refrigerator monitoring for cold chain drugs is one of the main essentials for insuring efficacy and safety of the drugs stored within these units, and a compliance requirement from the FDA, CDC, WHO, etc.
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!
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."
In an effort to cut costs and manage key areas within your cold chain logistics operation, DeltaTrak is offering a unique data logging solution, along with a fully documented Master Validation Plan (MVP).
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.
It is now approaching 2 years since the Chinese FDA began a push to adopt their proposal for regulations around Good Supply Practices (GSP) within China.
Although these regulations closely mirrored the EU GDP guidelines, and were focused on a ‘risk approach’ to managing quality, the expectation is for full adherence of these new regulations by the end of 2015.
With a growing emphasis on improving practices in distribution, internal processes, quality management systems, transportation, risk management, and mitigation protocols, it is important to evaluate the plans adopted by your vendors during your selection and audit procedures.
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