Pharma logistics: Prescriptions for compliance 

The critical importance of efficient pharmaceutical airfreight was illustrated by the pandemic as vaccines traveled by plane to reach people in the largest cities and most remote areas. 

“Airfreight is an essential part of pharma logistics,” Celine Crahay, founder and managing director of consultancy 3CeL, told Air Cargo Next.  

“I had the shipper last week who said it’s unavoidable,” she said, explaining that airfreight caters to last-minute needs and small volumes better than other modes of transport.  

Governmental organizations, including the Federal Aviation Administration, have regulations regarding pharmaceutical airfreight, and IATA offers CEIV Pharma certification. Nevertheless, British container company Tower Cold Chain identified regulatory compliance as a major hurdle for transporting pharmaceuticals. 

“Compliance with various regulatory requirements, including Good Distribution Practices [GDP], Good Manufacturing Practices and customs regulations, poses significant challenges and can be time consuming,” Francisco Azeredo, in-house sales manager at Tower Cold Chain, told Air Cargo Next.  

Still, compliance is important and must be pursued, he said. 

“Tower is taking several measures to tackle regulatory compliance challenges,” Azeredo said, “including adherence to GDP guidelines through staff training, improving our qualification and validation processes, and investing in advanced temperature monitoring technology to monitor and document environmental conditions during transit.”  

Creating checklists for CCPs 

Pharma.Aero, a nonprofit working to enhance pharmaceuticals transportation, published a white paper in April that created a set of guidelines for the safe and efficient transportation of time- and temperature-sensitive products to remote or geopolitically sensitive regions. 

Crahay, the project’s manager, said the organization undertook the project after seeing how vital airfreight was for distributing the COVID-19 vaccine. She said the team asked: “In the five steps — aircraft unloading, ramp transfer, handover to the warehouse, receiving and breakdown, [and] storage — what are the key good practices that need to be emphasized?” 

The white paper found: 

• Information flow needs to be accurate, timely and complete; 
• Sharing the information is critical; 
• Some steps in the supply chain often lack formalization, either by not sharing, receiving or confirming information — especially by ground handlers; 
• The highest risk at arrival is represented by the lack of confirmation of capacity and availability in terms of storage; 
• The local customs authority is essential to a smooth arrival/import process; and 
• The customs clearance process should be facilitated by the consignee. 

The project team wrote three checklists to be completed at different stages of the transportation process — three critical control points (CCPs).  

• The planning checklist, activated ahead of booking, collects information about shipping requirements, capacity and capabilities, and should be completed by the freight forwarder, airline and ground-handling agent. 
• The preflight checklist, activated before confirming the booking, is based on the planning checklist and should be completed by the airline, which confirms the shipment, routing and flight information prior to shipping. The completed checklist should be sent to the destination airport. 
• The arrival checklist, used by the ground handler at the destination airport, identifies each step that must be followed to ensure handling is done in a safe and timely manner. 

The CCP checklists are useful, according to the white paper: 

• To collect essential information to make the best decisions in terms of packaging, routing and booking;  
• To transfer the necessary information in an organized way to each relevant stakeholder so that each step can be performed as required;  
• To act as a step-by-step guide on how to handle the cargo upon arrival at the destination airport;  
• To collect the operational information demonstrating the proper handling at destination; and  
• To gather and align the efforts of the key stakeholders. 

Upgrading infrastructure, communication  

Tower Cold Chain’s Azeredo also sees infrastructure as a key concern. 

“Adequate infrastructure is necessary to serve an increasingly international market,” he said. “Managing an extensive network of suppliers, distributors and logistics partners across different jurisdictions can bring complexity in terms of coordinating shipments, ensuring regulatory compliance, tackling political and trade barriers, and navigating customs procedures.” 

To this end, Tower Cold Chain recently opened hubs in Incheon, South Korea; Milan; and Chicago. 

While the checklists prioritize communications across stakeholders, there must be infrastructure in place to allow such communication. 

“Maintaining end-to-end visibility and traceability of pharmaceutical shipments is crucial for managing inventory, minimizing losses and ensuring timely delivery,” Philip Ashton, chief executive and co-founder of supply chain management platform 7bridges, told Air Cargo Next. “However, the complex nature of air logistics can make it difficult to track and monitor shipments in real time, leading to potential inefficiencies and delays.” 

The artificial intelligence (AI) data-driven supply chain management platform from 7bridges promotes standardization of invoice terms, such as across suppliers. The platform’s AI adapts to changing circumstances and automatically selects the best dispatch site, route and carrier for each shipment, Ashton said.  

“This means that when air cargo is used, the business knows this is the best route for their product,” he said. “Plus, they can immediately retrieve the most up-to-date tracking information about the shipment. … This up-to-date tracking information is also crucial when it comes to mitigating security risks.” 

Andy Faes, regional manager of Healthcare Vertical Europe at Seattle-based logistics firm Expeditors, agreed that “visibility, track and trace tools … have provided a clear view on continuous improvement in the supply chain for the patients at the end of the logistics chain. 

“Most of the airfreight moves on airlines’ belly space; hence, the shippers are dependent on the airlines schedules, which sometimes makes it hard to plan,” Faes told Air Cargo Next. “In addition, the changing regulatory framework, visibility and cost management are all part of today’s challenges.”  

New warehousing technologies are also being introduced. The global cold storage market, for instance, was valued at nearly $139 billion in 2022, according to Grand View Research; it is projected now to grow at a compound annual growth rate of 17.2% from 2023 to 2030, reaching $485 billion. 

From A to Z, sustainability is key 

Sustainability in the pharmaceutical airfreight industry is a top issue for Crahay, who said that health care manufacturing and transport contributes an estimated 4.2% of the world’s carbon emissions. 

“Health care globally is a big contributor to the global carbon footprint,” Crahay said. “Overall, freight transportation and logistics activities contribute to 8% to 10% of the global greenhouse gas emissions.” 

Finding a green solution requires a balance of being effective and realistic. 

“There are very ambitious goals to decarbonize the sector,” Crahay said. “There is a need for more disruptive technology, like hydrogen or electric aircraft, but it’s not realistic.”  

Tower Cold Chain is also looking at ways to make pharmaceutical airfreight more eco-friendly. 

“Governmental pressure, shareholder intent and changing consumer behaviors have thrust sustainability front and center with many pharmaceutical manufacturers pledging on ambitious plans to become sustainable,” Azeredo said. “This is a long, multifaceted journey to find the optimum balance between operational efficiency, product protection and sustainability.” 

In addition to keeping products safe from physical damage and temperature excursions, Azeredo said containers must be reusable and not harmful to the environment. 

“These solutions stay in market circulation for a long time,” he said of greener options, including his firm’s KTEvolution container, which launched last year. “Robust in structure, these containers can withstand years of freighting, thereby decreasing packaging waste produced in comparison to single-use solutions, which are discarded after one journey.” 

The KTEvolution container, Tower’s smallest, was developed for smaller batch shipments such as clinical trials and is aimed at protecting pharmaceuticals in the last mile of delivery.  

Even with these many improvements and initiatives, there remains more room for growth in making pharmaceutical airfreight more efficient. 

“At its simplest, logistics is the art of getting a product from A to B,” Azeredo said. “But, when it comes to the pharmaceutical air cargo industry, nothing is ever this straightforward. Factor in the high value of pharmaceutical goods, their perishable nature and susceptibility to temperature changes, plus the numerous complexities of the supply chain, the reality is more like getting from A to Z.”