However, behind this apparent obviousness, a more complex reality has gradually emerged. GDP, as it has historically been designed, does not cover all the professionals involved in today’s actual pharmaceutical transport chain. This is not because it is obsolete or insufficient in its principles, but because certain links in the chain may fall outside the strict framework of the legislation.

With the globalization of flows, modes of transport have been combined and, above all, new intermediaries have become critical without fully entering the “traditional” scope of GDP.

This transformation is primarily that of the product. The pharmaceutical portfolio has become increasingly complex over the last few decades.

Thermosensitive drugs, biological products, vaccines, innovative therapies, and experimental drugs for global clinical trials have made transportation a central element of product quality.

Whereas in the past, the risk was mainly concentrated in the manufacturing and storage phases, it has now spread to the transfer, transit, and handling phases. In other words, to areas where the drug is particularly exposed, sometimes for short periods of time, but under highly variable operating conditions.

In this context, the pharmaceutical supply chain can no longer be analyzed solely through the prism of professionals traditionally subject to GDP, such as wholesalers or warehouses /transportation providers.

It must be understood as a much broader ecosystem, involving players who are neither manufacturers nor distributors in the strict regulatory sense, but who play a decisive role in product integrity.

These players are often not very visible to manufacturers’ quality teams, as they are located upstream or downstream of traditional control points. And yet, they are the ones who physically handle the drug during the most critical stages of its journey.

This reality can be described as the “invisible links” in the pharmaceutical chain. Invisible not because they are unknown, but because they have long been considered purely operational service providers, indirectly covered by quality agreements where they exist, without being fully integrated into a structured regulatory framework.

Airport handlers, various operators on the airport tarmac, transit platforms, ports, maritime terminals, multimodal operators: all these players, who are sometimes required to handle goods for a short period of time, operate in constrained environments, subject to security, fluidity, performance, and capacity requirements, as well as cost and profitability pressures. All of this can lead to tensions in the logistics chain and specific requirements for medicines.

Pharmaceutical companies sometimes believe they are covered against these risks through quality audits of their logistics providers, freight integrators, or other contracting companies, which are subject to regular audits, but the reality can be quite different.

As chains have become globalized, lengthened, and fragmented, this approach has become increasingly difficult to maintain. Auditing each intermediary individually, in each geographical area, with sometimes different standards, quickly became a dead end, both from the point of view of manufacturers and the operators themselves. Some realize this, while others overlook the risk.

Aware of these issues and also keen to improve the overall quality of the sector while reducing risks, the air transport industry has decided to tackle this problem head-on.

The use of air transport is generally driven by a need for speed or the critical nature of the products, or even their value. This makes it a sector where speed is key. But it is also a fairly fragmented sector, contrary to what it may seem.

A pharmaceutical shipment can pass through several countries, several platforms, and several organizations in a matter of hours. Each transfer involves a change of responsibility, zone, and sometimes operational culture.

In this environment, the role of handlers, for example, is central. They receive the goods, store them temporarily, move them between zones, and prepare them for shipment or delivery. They are at the heart of exposure times, operational decisions, and trade-offs in degraded situations. This can last a few minutes or extend to several days depending on the context, such as a weekend or weather disturbances.

Historically, these players were not fully integrated into a structured GDP approach. They were neither wholesalers nor distributors, and their main activity was not pharmaceutical.

GDP applied to them indirectly, through quality agreements or customer requirements, but without a harmonized framework at the sector level. 

This resulted in a wide variety of practices, a proliferation of audits, and increasing difficulty in establishing a level of trust between manufacturers and operators.

It was in this context that IATA CEIV (Center of Excellence for Independent Validators) Pharma emerged. It is essential to understand the nature of this initiative in order to grasp its importance. CEIV Pharma was never designed as a regulatory extension of GDP, nor as an attempt to redefine existing requirements.

It is a voluntary industry standard developed to meet a very specific need: to structure and harmonize the practices of players who, while not at the heart of traditional GDP, had become critical to the air pharmaceutical supply chain.

The creation of CEIV Pharma took place in a very specific context. The program was launched in 2014, at a time when the air transport of pharmaceutical products was experiencing rapid growth, driven by the increase of biotechnology, vaccines, and temperature-sensitive drugs.

At that time, temperature-related incidents were on the rise, as were audits conducted by manufacturers on their air carriers. Handlers, airlines, and airports found themselves under increasing pressure, with requirements that sometimes differed between clients, and without a harmonized industry framework.

It was in this context that the International Air Transport Association (IATA) launched CEIV Pharma in 2014 with a clear ambition: to create a common, internationally recognized standard capable of aligning the entire air cargo ecosystem with consistent pharmaceutical handling practices.

The objective was not to redefine GDP, but to translate its principles into a complex operational environment characterized by multiple interfaces and responsibilities. In this sense, CEIV Pharma has, from the outset, been a pragmatic response to a real-world need.

CEIV Pharma certification has brought about several major breakthroughs.

• The first was to propose a common, internationally recognized standard that allows for objective comparison of the pharmaceutical maturity levels of very different players.
• The second was to shift the debate from individual compliance to the collective robustness of the ecosystem. 
• Finally, it significantly reduced the audit burden on manufacturers, while providing operators with a clear roadmap for structuring their investments, training, and processes.

Beyond its content, CEIV Pharma has above all demonstrated that it is possible to fill the blind spots of GDP without weakening its requirements. It has shown that complementary standards can act as a “bridge” between regulatory principles and operational reality in the field.

This lesson is particularly relevant when we look at the current evolution of maritime transport in the pharmaceutical chain.

Extension. When maritime transport also adopts a “non-traditional GDP” standards approach

If CEIV Pharma has made its way and continues to develop in the industrial sector, it is also because there has been an increase in incidents, audits, and deviations in an extremely exposed environment. The complexity of pharmaceutical products, medicines, and logistics chains, as well as new climatic, geopolitical, and other risks, have also put more pressure on operators.

The maritime sector, on the other hand, has long evolved under the radar. Not because the risks did not exist, but because maritime flows in the sector were relatively low or the risks were of a different nature. These risks were also sometimes more difficult to detect due to a lack of technology, particularly in monitoring temperatures during transport.

A container that drifts slightly from its target range for several days does not attract the same attention as a sudden excursion onto a tarmac in the middle of summer. And yet, the potential impact on the product can be just as critical.

This difference in perception partly explains why, until recently, the maritime sector did not have a regulatory framework equivalent to that of the aviation sector. For a long time, the intrinsic performance of reefer containers served as an implicit guarantee. The technology was robust, the equipment reliable, and long-term thermal continuity appeared to be a decisive advantage.

It is important to note that a reefer container, however efficient it may be, never operates in isolation. It is part of an operational ecosystem that includes ports, terminals, authorities, and multiple operators, each with its own constraints, priorities, and levels of maturity.

It is in this environment that critical decisions are made:

where the container is parked while awaiting inspection, how long it remains disconnected, how flows are prioritized in congested situations, and what the actual capacity is to manage an alert or diversion over several days. These are all questions that go far beyond the scope of traditional GDP.

However, in recent years, maritime transport has gradually established itself as a credible pillar of the global pharmaceutical chain, far beyond its historical role as an alternative mode reserved for less sensitive volumes. This has also led to increased needs.

This development is primarily driven by the rise of the maritime cold chain. The global market for refrigerated containers is currently estimated at nearly $20 billion and is expected to reach approximately $28 billion by 2030, with annual growth of close to 6%⁽¹⁾.

This dynamic, historically driven by the agri-food industry, now includes a growing share of pharmaceutical flows, particularly for temperature-sensitive medicines, vaccines, and certain biological products, reflecting a structural change in manufacturers’ modal choices.

Beyond the overall growth of reefers, the segment specifically related to pharmaceutical transport is experiencing even more marked acceleration. Several studies estimate the value of the market for refrigerated containers dedicated to pharmaceuticals at around $3.6 billion in 2023, with projections reaching $9 to $10 billion by 2030–2031⁽²⁾, representing double-digit annual growth rates.

This growth reflects both the increase in volumes transported by sea and the higher quality requirements of shippers, who now expect maritime transport to offer levels of control, traceability, and proof comparable to those historically associated with air transport.

However, this maturation of the maritime sector is not based solely on container technology. It is accompanied by a more profound transformation of port ecosystems and operational practices.

Temperature-controlled cargo now accounts for around 12 to 15% of specialized maritime freight, supported by a global fleet of more than 250,000 reefer containers. In this context, ports and shipping companies are gradually structuring dedicated approaches to pharmaceuticals, integrating governance, prioritization of sensitive flows, and exception management.

Without constituting a formal standard equivalent to CEIV Pharma for air transport, this evolution reflects a clear convergence towards “GDP-like” standards, adapted to the specificities of maritime transport and indicative of a sector that has entered a phase of sustainable structuring.

At this stage, the parallel with air transport becomes obvious. In the same way that handlers have long been considered mere operational executors, ports and terminals have been perceived as neutral, interchangeable infrastructures over which manufacturers had little direct control.

However, experience shows that these environments are neither homogeneous nor equivalent. Their organization, governance, operational culture, and ability to integrate pharmaceutical requirements make a major difference in product risk management.

It is precisely this awareness that is now fueling broader thinking about the need for complementary standards for the maritime sector. This does not mean creating a new regulatory standard or imposing a model designed for air transport on the maritime sector. Rather, it means recognizing that certain links in the maritime chain, although outside the strict scope of GDP, must be evaluated, structured, and managed with a level of requirement equivalent to that expected of traditionally audited players.

This approach takes different forms depending on the region and the players involved.

Some ports are developing strategies explicitly geared towards pharmaceuticals, structuring their infrastructure, processes, and governance around this sector. Others are putting in place mechanisms for enhanced coordination between terminals, logistics operators, and local authorities in order to reduce areas of uncertainty and improve the management of degraded situations. We can see that these segments are becoming priorities for ports. This is the case for the Port of Antwerp-Bruges, for example.

On the shipping company and logistics operator side, we are also seeing a growing formalization of practices, with internal standards, specific training, and more transparent communication on the actual capacity to manage complex pharmaceutical flows.

A company like Maersk has prioritized this segment for many years, investing in technology, equipment, and human resources. Others are doing the same.

This movement remains heterogeneous, which is undoubtedly one of its key characteristics. Unlike the airline industry, where extreme fragmentation made it necessary to establish a harmonized framework relatively early on, the maritime industry operates in a wide variety of configurations that are highly dependent on local contexts.

A large European hub port, a transshipment port in the tropics, or a secondary port serving regional markets do not face the same constraints or expectations.

However, this diversity does not mean that there is no convergence. Pharmaceutical manufacturers, faced with increasingly long and complex supply chains, are formulating increasingly similar expectations, regardless of the mode of transport, especially as the desire to use alternative transport systems to air transport is currently driving strong growth in maritime transport.

They demand visibility, alert notification, traceability, a proven ability to manage exceptions and, above all, clear governance of responsibilities. They are not necessarily looking for a new universal certification, but credible assurance that the critical links in the chain are identified, trained, equipped, and managed in a consistent manner.

In this context, the role of complementary standards takes on its full meaning. As CEIV Pharma has done for air transport, these emerging approaches in maritime transport create an intermediate space between the regulatory framework and operational reality.

It is important to emphasize that this evolution does not only concern quality in the strict sense. It is also part of broader dynamics related to supply chain resilience, global risk management, and ESG issues.

The partial shift of certain flows from air to sea transport, encouraged for environmental reasons, can only be credible if product quality and integrity guarantees are in place. Here again, complementary standards play a facilitating role, making objectives that are sometimes perceived as contradictory compatible.

In the longer term, this dynamic raises a fundamental question for the entire pharmaceutical industry: how far should regulatory requirements be extended to secure the logistics chain without making it excessively rigid? GDP has established a solid framework, but it cannot, on its own, absorb the growing complexity of global supply chains. Experiences in the aviation and, now, maritime sectors show that it is possible to innovate in terms of governance without calling into question the regulatory foundations.

This move towards more appropriate, more targeted standards that are closer to the field is undoubtedly one of the clearest signs of the growing maturity of pharmaceutical logistics. It reflects a more nuanced understanding of risk, but also a collective desire to no longer leave certain links in the blind spot of quality systems. In this sense, it is not just a normative debate, but a profound cultural shift: one that recognizes that the quality of medicines extends far beyond the traditional boundaries of GDP.

Definition

Hander: A handler (or cargo handling agent) in airfreight is a specialized service provider responsible for the physical handling, loading, unloading, and storing of cargo and baggage on aircraft at airport terminals.

Reefer container: A reefer container (refrigerated container) is a specialized intermodal shipping container with an integrated, active cooling system used to transport or store temperature-sensitive goods, such as food, pharmaceuticals, and/or chemicals. They maintain precise, controlled temperatures.

Glossary

• CEIV Center of Excellence for Independent Validators
• GDP Good Distribution Practice 
• GMP Good Manufacturing Practice 
• IATA International Air Transport Association

References

• 1. Refrigerated Container Shipping Market – Growth, Trends, Forecasts (2024–2030) – Mordor Intelligence
• 2. https://www.insightaceanalytic.com/report/reefer-container-for-pharmaceutical-market/2886