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By William DiBenedetto, CBN Features Editor
Even the best pharmaceutical, biologic, food and other temperature-controlled products can fail without effective and knowledgeable cold supply chain partners to handle the logistics side of the equation.
This is not news of course, but the cold chain is more than a complex, constantly evolving process. This is because, more than most other supply chain relationships, the best cold chains are really collaborative partnerships. It is crucial to get it right in a highly regulated environment.
UPS has noted — based on a study by the UK-based Medicines and Healthcare Products Regulatory Agency (MHRA) — that more than 40 percent of critical and major product deficiencies are related to ineffective temperature control. The stakes are high because as UPS also recently noted, by 2016 world sales of cold-chain drugs and biologics such as vaccines and blood plasma products will approach $240 billion.
Protecting these products throughout the transportation logistics cycle is critical. Establishing a temperature-sensitive protocol has four steps, according to UPS:
• Planning to maintain product integrity
throughout the transportation journey and
meeting the guidance and requirements of
regulatory agencies.
• A discussion of product requirements about the
transportation mode, temperature sensitivity and
permitted excursions.
• A design solution, including packaging options
that optimize value throughout the transportation
process while defining service levels, primary
and backup routings, documentation
requirements and standard operating
procedures.
• Contingency plans that jointly identify potential
problems, with alternative transport plans,
including a return and replacement plan for
compromised products.
Bottom line: cold chain integrity should never be compromised. That’s why the term Good Distribution Practice (GDP) is more than a catchphrase. GDP guidelines include monitoring and reporting requirements in the cold chain. GDP and Good Automated Manufacturing Practice (GAMP) guidelines also require mandatory reports in a standard format to demonstrate compliance.
"There is now a good deal of awareness of the need for proper cold chain management in the storage
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and transportation of temperature-sensitive products in the pharmaceutical and food industry," says Rene Tjong Tjin Tai, CEO of Dyzle, in a recent report for ColdChainIQ. Dyzle is a real-time cold chain monitoring platform that helps provide proof of product integrity of temperature-sensitive products being handled in the food, pharmaceutical and retail logistics cold chain.
He identified the trends that are moving the cold chain to the next level, with capacity, "last mile," and security becoming increasingly important.
Tai outlined five cold chain trends to watch this year:
• Creation of additional capacity and capability of
handling for cold chain products - "there is a
shortage of both at warehouses as well as 3PLs."
• Proper last mile delivery and storage - "this is
still an issue in many emerging economies that
don’t have proper end to end cold chain
infrastructure, and this also needs to include
return of products."
• In air/at sea temperature monitoring -
"temperatures can already be monitored in the
air but cannot currently be transmitted in real
time as the wireless radio connection has to be
switched off in air."
• GDP-like inspections by the regulators in the
last-mile - for example, at pharmacies.
• Maximizing the benefits of investments in
serialization, security, GS1 and temperature
monitoring by integrating solutions.
He said the last point, serialization, "is an important one in the battle against counterfeit drugs, and ensuring supply chain security."
Expect new legislation in a number of countries, Tai said, forcing multinational companies to look at effective ways of coding individual products around the world. "The ability to track and record each item’s movement across borders will mean new challenges and requirements for pharmaceutical companies in implementing serialization standards."
Tai said the cold chain industry is entering a new phase "where issues like capacity, last mile delivery, and product security become as important as the capabilities that we are currently seeing to monitor the cold chain."
Next: The numbers and the challenges
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