IMPERATIVES FOR COLD CHAIN QUALITY: Part 2 – Selecting Partners Based on Requirements and Capabilities

The international cold chain thrives on partnership. When moving life-saving drugs to markets around the world, the foundation for preserving product viability is ensuring shippers can access the necessary logistics capabilities for their delicate pharmaceutical cargo. Choosing the right partners who can satisfy product and shipper needs does not just impact the bottom line. It is essential for the health and welfare of the patient waiting at the end of the cold chain.

This article series explores five of the most important best practices for enhancing time- and temperature-sensitive program development in the demanding field of pharmaceutical logistics. In the previous installment , we looked at the importance of identifying a shipment’s scope by building an understanding of the product, partner capabilities, and the roles and responsibilities throughout the supply chain. Preserving integrity and product safety during transit demands communication and collaboration, but just as important is ensuring that a shipper works with logistics companies whose capabilities match the precise needs of their products. To that end, this series installment looks at partner selection and what pharmaceutical shippers should investigate when evaluating programs and partner capabilities.

Each logistics partner brings a different set of experiences and operational investments. Moving temperature-sensitive pharmaceuticals raises a unique set of challenges, and safely handling these products necessitates some specific qualifications. Chief among these are detailed policies and procedures for handling temperature-sensitive pharmaceuticals. These guide how a logistics partner attends to the shipment, from proper documentation to expert operations and also contingency plans. Part of this means a clear understanding of shipper expectations to which the correct procedures are applied. Communication in that regard is critical, and effective logistics partners can apply their expertise to the product and shipper’s needs by defining the precise requirements for each shipment.

Ensuring the established procedures are consistently followed, however, demands focused training throughout an air forwarder or carrier’s network. Management and operations staff alike must bring a keen understanding of how to best work with and protect temperature-sensitive pharmaceuticals, and this is best accomplished through a robust and highly developed global training program.

Once in the supply chain, monitoring cargo conditions – such as temperature, humidity and location – is paramount for ensuring that product viability is maintained. As such, logistics partners should be able to offer a high-visibility system for communicating cargo information to their customer. This can include cargo tracking capabilities (such as American Airlines Cargo’s FlightSafe® program), but it also relies on diligent operations throughout the global network.

Temperature and other conditions can vary across transportation modes and regions, and preserving pharmaceutical viability in all cases requires infrastructure investments (such as Controlled Room Temperature facilities), as well as procedures for supporting cargo requirements. While communicating with one’s logistics partners can reveal what stations and facilities are available, there is no substitute for first-hand experience. Shippers should take opportunities to visit the facilities a logistics partner brings to bear, conducting on-site assessments to ensure infrastructure and operations meet a product’s specific needs.

These partner qualifications go a long way towards promoting cold chain integrity, but to ensure that capabilities and procedures achieve what is intended, all partners in the cold chain should have the ability and willingness to measure operational compliance and the results of a shipment. This is important not only for when a shipment reaches its destination, but also, for improving the handling and care of shipments in the future.

In the essential process of measuring results, logistics partners should evaluate Key Performance Indicators (KPIs). These allow partners to understand successes, and in the case of challenges to product viability, the evaluation should look at why the challenge occurred and also use these results to guide corrective actions for future shipments.

Identifying any instances where the logistics process broke down or fell short of what was needed informs which cold chain enhancements should be applied. This should be done with the shipper, reviewing issues that impacted service, and critically, whether it resulted in concern for product viability. The key to any effective Quality Management System (QMS) is joint reviews of quarterly performance, which are conducted with the participation of all stakeholders, including the shipper. These can reveal areas where improvement is needed and can inform Corrective and Preventative Actions (CAPAs). Responsible and capable logistics partners should be willing to meet and discuss the implementation of CAPAs as needed.

When the correct partners are selected, and there is a supply-chain wide understanding of a shipment’s scope, the next step to ensuring cold chain quality and product viability is a collaborative approach to moving the pharmaceutical cargo. In the third installment of this series, we look at how pharmaceutical supply chain partners can and should work together to implement programs.

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IMPERATIVES FOR COLD CHAIN QUALITY: Part 2 – Selecting Partners Based on Requirements and Capabilities

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