Rigorous Realities – Enhanced Expectations in the Air Cargo Cold Chain

Advancements in pharmaceuticals are changing the face of 21st century medicine, giving patients around the world access to new life-saving drugs and vaccines. Because many of these innovative pharma and biopharma products are temperature-sensitive, the growing global pharmaceutical market is driving demand for cold chain logistics. By 2018, the worldwide biopharmaceutical market is expected to reach sales of $177 billion, according to the research firm IMARC Group . With so much at stake – both a product’s monetary value and the priceless value of human life – building an effective, consistent cold chain has never been more important.

The logistics industry has responded to the growing demand for cold chain services with a host of solutions. In air cargo, for example, some airlines (like American) have made major investments in training, infrastructure and planning to improve their ability to safely transport temperature-sensitive pharmaceuticals. At the same time, in an effort to protect pharmaceutical viability (and therefore patient safety), there has been a rapid expansion of regulations for transporting and documenting cold chain cargo. As such, shippers, forwarders, air carriers and other cold chain stakeholders are left to face a dramatically evolving and rigorous regulatory environment.

There are numerous regulatory bodies governing how pharmaceuticals are transported, guarded and documented in the cold chain. There are trade organization guidelines for how industries work with temperature-sensitive pharmaceuticals, such as the International Air Transport Association’s (IATA) Chapter 17 in the Perishable Cargo Regulations (PCR) , the Parenteral Drug Association’s (PDA) Technical Report 39 , and U.S. Pharmacopeia’s (USP) General Chapter 1079 . There are also international bodies setting cold chain standards, such as in the World Health Organization’s "Good Distribution Practices." Complicating the regulatory environment further, there are country-specific customs regimes with their own standards for moving temperature-sensitive cargo. Canada, for example, has strict guidelines for pharmaceutical imports, as does Ireland, Brazil and numerous other countries. All of these regulations must be satisfied on the journey from pharmaceutical manufacturer to patient.

Collectively, this is creating a rapid increase in the amount and type of regulatory oversight. While all these regulations are geared towards maintaining product integrity and patient safety, they also make moving temperature-sensitive cargo a complex, nuanced endeavor. On its journey, temperature-sensitive pharmaceuticals can cross different climate zones, encounter a range of threats to viability, and change hands between several forwarders, handlers, and even airlines. These and other conditions present potential threats to temperature-sensitive pharmaceuticals, and cold chain logistics partners must adhere to the myriad regulations designed to mitigate threats in transit.

Making the challenge more difficult still, regulations and requirements can conflict with one another and between stakeholders. Some stakeholders might even have different priorities and divergent understanding of what the regulations mean for fast, efficient cold chain transport. Addressing the differences between regulations and ensuring all stakeholders adhere to rules, while also achieving the speed and efficiency critical to the international pharmaceutical cold chain, demands collaboration.

Pharmaceutical manufacturers, freight forwarders, air carriers and other stakeholders must have detailed conversations and group planning before a temperature-sensitive shipment enters the cold chain. This means anticipating regulatory hurdles, agreeing on standards for documentation, understanding transfer times between flights and transportation modes, and adhering to all applicable rules – this while also delivering life-saving pharmaceuticals on time.

Improving cold chain transportation is a global priority, for regulatory bodies and cold chain stakeholders alike. Shippers, forwarders and carriers are all motivated to ensure pharmaceutical shipments reach the patient within a consistently viable temperature range. The challenge for the logistics industry is to harmonize our understanding of cold chain requirements and align our practices for moving temperature-sensitive pharmaceuticals. As the regulatory landscape becomes increasingly complex and demanding, the logistics industry must collaborate on the best methods for implementing standards and processes that follow industry and governmental guidelines. This is critical to the ongoing effort to improve handing of temperature-sensitive cargo, maximizing cold chain quality while minimizing the impact from divergent regulations.

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Rigorous Realities – Enhanced Expectations in the Air Cargo Cold Chain

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