In this context, every step is of critical importance: every shipment, every temperature fluctuation, every party involved, and every inspection conducted can have a direct or indirect impact on product integrity. The pharmaceutical supply chain thus emerges as a critical link, where even the slightest failure can lead to significant health, regulatory, and economic consequences.

At the heart of this critical supply chain, carriers play a strategic role. They are responsible not only for transporting products, but also for ensuring compliance with safety and traceability requirements and maintaining proper storage conditions throughout the entire transport process. In this context, close and structured collaboration between pharmaceutical manufacturers and carriers becomes a key success factor, essential for ensuring product quality, regulatory compliance, and, ultimately, patient safety.

Collaboration between manufacturers and carriers: a strategic partnership

In the vast majority of cases, transportation is an activity outsourced by pharmaceutical manufacturers. As such, carriers act as subcontractors to the client. However, when it comes to healthcare products, this traditional contractual relationship cannot be limited to a simple logistics service. The carrier can no longer be considered an ordinary supplier: it becomes a full-fledged strategic partner in the drug distribution chain.

In fact, its responsibilities extend far beyond the physical transport of goods. The carrier must ensure that products are delivered on time, which is essential for the continuity of care and the availability of treatments. It must also optimize routes and transport conditions to limit the products’ exposure to environmental factors that could compromise their quality, such as temperature fluctuations, humidity, or excessive delays. Ensuring product security throughout all journeys is another major challenge, whether it involves preventing theft, loss, damage, or any form of tampering.

In addition to these requirements, companies must comply with the various laws and regulations applicable depending on the mode of transport used and the countries traversed, as well as adhere to Good Distribution Practices or equivalent international standards.

This close collaboration between manufacturers and carriers makes it possible to anticipate emergencies, prioritize sensitive or critical products, and ensure the continuity of the supply chain, while contributing to the overall improvement of the pharmaceutical supply chain’s performance.

To ensure the effectiveness and reliability of this collaboration, it is essential that the principal maintain strict control over the activities entrusted to carriers. The Good Wholesale Distribution Practices (GWDP) explicitly outline this responsibility. Thus, the principle set forth in §7.1 specifies that any outsourced activity must be clearly defined, accepted, and monitored to avoid any misunderstanding that could affect the integrity of the product. Similarly, §7.2 reiterates that the principal remains fully responsible for the activities it subcontracts.

Within this regulatory framework, the carrier is therefore fully integrated into the client’s quality system. The carrier must undergo a rigorous qualification process, based on an in-depth initial assessment and periodic reviews designed to ensure that its level of compliance is maintained. This control is based on several fundamental pillars: formalized contractual arrangements through quality agreements that precisely define the roles and responsibilities of each party; verification of the skills and training of the personnel involved; and the qualification and validation of the means of transport used, particularly for temperature-sensitive products.

Carriers must be able to demonstrate their ability to maintain the required storage conditions throughout the entire journey. This involves the use of qualified vehicles, reliable temperature control, monitoring, and recording devices, as well as robust procedures for managing deviations, incidents, and deviations. The traceability of flows, batches, and associated data is also a key element, both to meet regulatory requirements and to enable a rapid and effective response in the event of an anomaly or incident.

The implementation of quality agreements, audits, performance metrics, non-compliance tracking, and corrective action plans—which form part of the work carried out by the GIC A3P BPD Supply Chain—helps embed the relationship with carriers within a framework of continuous improvement. Thus, the oversight of carriers under the BPDG goes far beyond simple operational monitoring: it is part of a comprehensive risk management approach aimed at ensuring the safe distribution of medicines and preserving their quality until they are made available to the patient.

However, the effective implementation of Good Distribution Practices (GDP) proves particularly complex when transport is entrusted to carriers that do not specialize in the pharmaceutical sector. These carriers, which often handle multi-client and multi-product shipments, do not always have a quality system that is sufficiently robust to meet the specific requirements of healthcare products. Lack of familiarity with the regulatory framework, inconsistent operational practices, or a lack of specific staff training can create significant risks, particularly regarding cold chain compliance, incident management, and the reliability of traceability data.

Furthermore, while route consolidation allows for cost optimization and has a positive impact on the carbon footprint, it makes it more difficult to monitor transport conditions and increases the risk of cold chain breaches or contamination. Integrating these carriers into the client’s quality system requires significant investment in terms of qualification, audits, document tracking, and operational support. Ensuring compliance with Good Distribution Practices (GDP) in this context demands heightened vigilance and strengthened collaboration to compensate for the lack of pharmaceutical specialization and to ensure the safe distribution of medicines to the end patient.

Added to this complexity is the management of carriers operating on a global scale across road, sea, air, or multimodal transport networks, each with its own specific operational, regulatory, and cultural constraints. GMP requirements must be applied consistently, even though the maturity levels of quality systems, logistics infrastructure, and transport practices can vary significantly from one country to another. International transport also exposes healthcare products to increased risks, such as longer transit times, multiple transshipments, customs constraints, or the use of local subcontractors who may not be readily visible to the client.

In this context, ensuring control over transport conditions, maintaining the required temperature, and ensuring the reliability of traceability data poses a significant challenge for players in the pharmaceutical supply chain. The supply chain must therefore rely on rigorous partner qualification, global standardization of quality requirements, and enhanced coordination among all stakeholders to ensure compliance with GMPs throughout the entire logistics process, regardless of the mode of transport or geographic region involved.

Given all these risks, failure to comply with or provide sufficient evidence of control over transport temperatures poses a significant regulatory risk for operators and distributors, who bear ultimate responsibility for the quality and safety of the medication under all circumstances.

The cold chain: essential for the safety of ready-to-eat foods

Vaccines, biologics, plasma-derived products, and innovative therapies are among the most sensitive healthcare products in the pharmaceutical supply chain. Their stability, therapeutic efficacy, and safety depend heavily on strict adherence to storage conditions, particularly regarding temperature. These products therefore require rigorous and controlled management of temperature conditions at every stage of their logistics lifecycle, from the moment they leave the manufacturing plant until they are administered to the patient.

Good Distribution Practices therefore impose particularly strict standards, justified by the significant health risks associated with any deterioration of these products. Indeed, a single transportation incident—such as an uncontrolled temperature deviation—can compromise the quality of entire batches, result in their destruction, and, above all, lead to product shortages or even endanger patient health. In this context, the distribution chain must be considered a critical chain, within which every parameter, every control, and every operational decision directly contributes to preserving product efficacy and patient safety.

Controlling transport temperatures is therefore one of the fundamental pillars of Good Wholesale Distribution Practices (GWDP). It relies above all on a clear, precise, and scientifically justified definition of the transport conditions applicable to each product. Under no circumstances can the transport temperature be defined in a generic or standardized manner. It must be based on the storage conditions authorized by the Marketing Authorization (MA), as well as on a thorough analysis of the risks associated with the relevant logistics flows (climatic conditions, mode of transport, duration, etc.).

Based on these factors, a tailored transportation plan can be developed that is fully consistent with the specified temperature range. This plan includes, in particular, the selection of the most appropriate modes of transport, the choice of qualified and validated packaging, the definition of routes and maximum acceptable transit times, as well as the identification and management of potential transshipment points. This entire process must be formalized, documented, and integrated into the quality system to ensure the traceability of decisions and the reproducibility of practices.

This approach cannot be set in stone. It must be subject to regular reviews, particularly when introducing new products, new logistics flows (such as the opening of new transport routes or the addition of new destination countries), or when engaging new service providers. Any change likely to affect transport conditions must be analyzed in terms of its potential impact on temperature control and compliance with the requirements of Good Wholesale Distribution Practices.

Furthermore, managing temperature excursions is a major challenge in the transport of temperature-sensitive products. Any deviation from the defined conditions must be reliably detected, comprehensively documented, and scientifically evaluated in light of the product data to determine the potential impact of the deviation on the quality, safety, and efficacy of the drug, and to decide whether to release or reject it.

A robust out-of-specification management strategy relies on clear, operational procedures that define roles and responsibilities, processing timelines, and decision-making criteria. It also requires strong operational responsiveness and close collaboration between the supply chain, quality, and regulatory affairs teams. The objective is not only to prevent deviations but also to demonstrate, in the event of an incident, scientific, technical, and regulatory control over the decisions made, in accordance with GMP requirements and the expectations of health authorities. These temperature control issues constitute the second focus area of the GIC A3P BPD Supply Chain.

Conclusion

In the supply chain governed by Good Distribution Practices for Wholesale Distribution of Medicines, transportation can no longer be viewed as merely an operational link in the logistics chain. It is a central and strategic component that ensures the quality, safety, and compliance of healthcare products throughout their journey, from the manufacturing site to their delivery to patients. Control over transport conditions—and in particular critical parameters such as temperature, security, and traceability—directly determines the therapeutic efficacy of medications and the trust placed in the pharmaceutical distribution system.

In an increasingly demanding regulatory environment, the digitization of processes, enhanced traceability of workflows and data, and close, structured collaboration between manufacturers, distributors, and carriers are emerging as essential tools for meeting the expectations of health authorities. These tools and practices not only help secure operations and prevent risks, but also enable companies to demonstrate, in an objective and documented manner, compliance with GMP requirements during inspections and audits.

Investing in specialized transportation solutions, qualified partners, and high-performance tracking systems is therefore equivalent to investing in the overall resilience of the pharmaceutical supply chain. This approach helps improve operational performance, strengthen risk management, and ensure continuity of care. Ultimately, effective transport management is not merely a logistical or economic issue: it is an integral part of a commitment to healthcare responsibility, serving patients and healthcare professionals, and constitutes one of the pillars of drug safety.

The GIC A3P BPD Supply Chain’s work on these issues will be discussed on June 10 in Lyon!

A guide titled “Managing Carriers” will soon be available in the members’ area.