COLLABORATING IN THE COLD CHAIN: The Case for SOP Three-Party Development

Moving cold chain cargo is like a football match. Players move down the field, encountering a path full of obstacles, threatening to make them lose the ball. To succeed, the team must decide each player’s role and responsibilities – critically – before the match. The same logic is essential in cold chain logistics, and the tool that helps make this possible is the Standard Operating Procedure (SOP) agreement.

SOPs are an essential element in today’s complex world of pharmaceutical development and distribution. While SOPs are routinely negotiated between the pharmaceutical manufacturer and the forwarding agent, there are other stakeholders who share responsibility for protecting cargo on its journey to the patient. The best team efforts are inclusive, and in building a game plan for cold chain logistics, a critical question is, who should be included in the SOP conversations?

From the moment temperature-sensitive pharmaceuticals leave the manufacturer, it is a race against time and conditions to bring life-saving medicines to the people who need them. Collaboration is critical for all stakeholders, but an effective SOP is best when jointly developed between the pharmaceutical manufacturer, the forwarder and the carrier.

Bringing these three central stakeholders together can help establish how they will collectively overcome threats to product viability. This process does not replace the SOP between the manufacturer and forwarder; it enhances it. A three-party development of the SOP – as well as the Service Level Agreement (SLA) defining customer expectations and performance time– facilitates all parties’ understanding of their roles and responsibilities. It provides the opportunity for conversations that take a wider view of the transportation chain, improving logistics providers’ ability to offer reliable, transparent and safe handling of delicate pharmaceutical products.

Forwarders and carriers share a common objective, but they perform different functions. Air carriers usher cold chain cargo through threatening conditions, from the heated tarmac to freezing air at 30,000 feet, challenges unique to air cargo’s segment of the supply chain. Many carriers have programs designed to protect cold chain cargo through these conditions, but to be most effective, they must understand the product requirements and restrictions. SOP discussions well in advance of wheels-up facilitate this understanding.

At the same time, manufacturers and forwarders are also experts over their portion of the cold chain, though they face a different set of threats to product viability. Three-party SOP discussions provide an opportunity for the manufacturer to meet with the forwarder and their carrier partner to understand their carrier’s cold chain program in greater depth, which can enhance handling and decision making. Discussions define operational specifics, handling procedures, contingency planning and the communication processes used once shipments are tendered at the airport.

Contingency planning in particular is a critical part of any SOP, and it demands clear and consistent lines of communication between all stakeholders. Missed flights, delayed pick-ups, expiring packaging validation periods and other challenges can pose real threats to temperature-sensitive cargo. What is more, not all destinations and markets offer the same level of cold chain infrastructure, handling and transportation; emerging markets can be especially challenging. An SOP can help in planning for these complications, and it also offers a baseline from which to measure performance for all cold chain stakeholders, which is critical for correcting and improving the movement of goods from manufacturer to patient.

Like football, the cold chain is a team effort; unlike football, however, moving life-saving, temperature-sensitive pharmaceuticals is not a game. It is serious work that contributes to the health and wellness of people around the world. The closer manufacturers, forwarders and carriers can work together before a product enters the supply chain, the better able they are to protect the cargo throughout its perilous but essential journey.

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