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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.
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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A new release from DeltaTrak® offers possible tracking solutions for import/export operations. Single-use and compact in size, DeltaTrak® says that its FlashLink Mini PDF In-Transit Logger was developed for streamlined ease of use.
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.
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."
The produce industry is getting prepped for the release of the final phase of the Food and Drug Administration’s Preventive Controls for Human Food ruling. Going forward, you’ll be seeing an increase of innovative applications being used throughout the food distribution chain; all aimed at reducing the loss of product during storage or in-transit.
By Ray Caron
Author: Ray Caron
Ray joined DeltaTrak in 2010 as Marketing Manager and currently holds the position of Senior Vice President of Marketing, Business Development and Chief Operating Officer of DataMark Inc.
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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).
The current buzz word in technology today is The Internet of Things (IoT). The definition is typically understood as “everyday objects having network connectivity, allowing them to send and receive data.”
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.
Delays in cooling after harvest and improperly cooled produce means significant loss of shelf life. FlashTrak Telematics Pre-Cooling Solution is an automated technology that improves efficiency of your operations. Are you pre-cooling too long or not long enough?
DeltaTrak, Inc. is a finalist in the New Product Awards Competition during United Fresh 2015, June 9 & 10. DeltaTrak’s FlashLink PDF Multi-Use Data Logger is a plug-and-play temperature logger with built-in USB connector and on-board software. This device allows an easy way to download data as a secure PDF to a PC without special reading devices or additional software.
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.
DeltaTrak’s Director of Strategic Sales, Robert Bright, presented the FlashTrak Telematics solution and its product emulation capability to the Supply Chain Logistics Council during the United Fresh Midwinter Leadership Forum. This pioneering technology, with mobile and facility applications, gives produce growers, shippers, and receivers the ability to monitor the actual product temperature from harvest through the pre-cooling process, and during transportation and storage.
DeltaTrak showcased its new FlashLink Cold Chain Export USB Data Logger. This single-use, in-transit data logger is designed specifically with DeltaTrak cold chain USB data logger export shipments in mind, to track products from the packing shed to the dock, from port to port, all the way to warehouses and distribution centers overseas.
It seems like every time you pick up a trade journal, some company or the other is offering a last mile solution.
Whether this is a special package that has been validated for "x" amount of hours, or a device no different than a basic chemical indicator that will give you a good or bad forensic analysis after the event.
Do you have an up-to-date food safety plan? How secure are your sanitary transportation operations? Are your standards and procedures on par with the sanitary cold chain market? Do you have an HACCP plan in place already? If you were approached for an audit, would you pass an FDA inspection and be able to show officials your records dating back at least two years?
With the fairly recent DQSA (Drug Quality and Security Act), plus new regulations in China for GSP, and the EU for GDP, plus rumors that Japan will be adopting the EU GDP guidelines, it seems that global regulations are becoming harmonized. These regulations are based upon quality, risk mitigation, and the measures taken to prevent adulteration or the counterfeiting of drugs.
If all goes as the FDA plans with its Food Safety Modernization Act, importers will soon be required to meet the same level of public health protection as food that is produced in the United States. The new law is meant to significantly enhance the FDA’s ability to oversee the millions of food products coming into the United States from other countries each year. This ruling is also intended to reduce annual costs associated with imported foods and food borne illness.
With all the “Breaking News” headlines we receive related to food safety matters, it is easy to get troubled on the domestic front, or for any of us that travel abroad. The weekly saturation of emails and notices I read on this topic reveal disturbing facts that would turn even the most iron-clad of stomachs sour.
Ongoing programs like the VFC (Vaccines for Children) and the Pneumonia vaccine for the older members of the community are seen as annual programs. However, we always associate the Flu vaccine with fall and winter.
Is your company meeting Produce Traceability Initiative (PTI) guidelines? This initiative was introduced in 2009, and has been built as a roadmap to a common standard for external traceability. Implementing this initiative is a critical strategy that will help your company comply with strict food safety and supply chain regulations.
Like many of us that work in this industry I always follow very closely the presentations from the Spring and early Summer rounds of trade events and industry meetings to see what might be new.
Being that cold chain and drug security are close to my own areas of personal interest I always tune in on the articles and data related to these two areas.
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.
According to the FDA, an estimated 83,609 businesses will be affected by FSMA and the proposed Sanitation Transportation Rule. These businesses must start complying with the new requirements 60 days after the final ruling. The FDA has recently extended the comment period on this proposed rule to July 30 2014, with some leeway being given to smaller businesses.
With the recently proposed FSMA ruling set forth by the FDA, Deltatrak, Inc. is poised to establish itself within the food industry as a leading cold chain monitoring and solutions-based company. DeltaTrak’s contamination prevention tools and monitoring technology will help handlers, suppliers, and distributors comply with the Sanitary Transportation of Human and Animal Food Rule's strict guidelines and food safety standards.
Most of the focus of this blog is generally on the pharmaceutical side of the business related to cold chain, supply chain and the management of temperature controlled drug related products.