Editorial | Open Access | Published 1th July 2025

GUEST EDITORIAL: International Pharmaceutical Distribution: Maintaining Product Quality

Author: Nicole Lyons

Key words/phrases: Pharmaceutical Supply Chain, Product Quality, GxP, Good Distribution Practice, Global Distribution

Introduction/abstract

In the international market, everything has an additional layer of complexity. Decisions need to be communicated quickly, and across multiple time zones. But in a world where one decision can impact thousands of patients, it is important that adequate research and planning takes place ahead of a product being dispatched from the manufacturing site so that any known risks are mitigated ahead of its final destination – and before it reaches patients.

Compliance to one set of regulations is not sufficient to maintain product quality in the global supply chain. Compliance must be met in every territory the product moves through or your company operates in, meaning your procedures and processes need to be robust enough to ensure product quality is upheld regardless of language, time zone, climate and regulatory jurisdiction. If not, the supply chain quickly becomes a nuanced opportunity for criminal interference, delays, and compromised product quality.

Introduction

The world is becoming smaller and more fast paced, with access to almost infinite sources of information. There are new announcements being made regularly which describe how the latest innovative technology will benefit the manufacturing process (and patients), and countless opportunities to improve every aspect of our lives.

Yet the pharmaceutical supply chain is becoming increasingly complex; products regularly cross multiple borders between the manufacturing site and the end user. Climate change is causing unprecedented temperatures and unusual weather events. There are often several activities being outsourced, each requiring a detailed written agreement between parties to ensure responsibilities are clearly defined at every stage. Criminals study industry activities, refining their approach so that attempts to infiltrate the supply chain are more sophisticated than ever.

Some of the challenges faced cannot be eradicated completely. For example, the intentional actions of bad actors within the supply chain can rarely be stopped – where there is profit to be made, there will be a demand for criminal activity.

Likewise, adverse weather events cannot be prevented altogether, but by understanding the territories you operate in, and how to identify unusual activity, you can create protocols which ensure appropriate checks are completed ahead of dispatch and contingency plans are in place in case of potential unpredictable events, such as a surprise storm, flight disruption, or attempted theft.

This means that everyone in the supply chain can be empowered to prevent unnecessary impact on product quality.

Areas of risk in the international supply chain

There are many different ways product quality and/or patient safety can be affected during pharmaceutical distribution. Some of the main risk areas are listed below:

- Regulation disparity. Different countries have different regulations, with varying levels of similarity; when completing the import/export of medicinal products, you must understand the regulations in each territory.

- Criminal interference. Profit can be made from diverting medicinal products away from, and/or introducing falsified medicinal products into, the legitimate supply chain; security must be maintained throughout the journey to ensure no tampering or theft takes place.

- Maintaining storage conditions. A shipment is often subjected to several climates before it reaches its destination market; you must appropriately control and monitor the storage conditions of a product throughout the duration of its journey.

- Utilising third party companies. Outsourcing activities such as transport and completion of customs documentation is common when distributing internationally; it needs to be assured that products will be handled appropriately and that there is sufficient oversight.

- Customs and border control. The provision of correct information for customs declarations is critical to ensuring products are appropriate for the destination market and delays are prevented; ensure documentation is accurate and that any customs regimes are accounted for.

Preparation is essential

Most risk areas are worsened through lack of adequate research or knowledge. To be able to control risk areas, you must first know the markets you are distributing to and the product(s) you are shipping. Then, you can select the best transport method and route for a specific product or group of products.

Each combination of decisions will result in a different level of risk, so it is important to assess each transaction and route individually so that suitable mitigation is applied to achieve an acceptable risk level for each shipment.

The approaches described below give an indication of considerations within each risk area to apply appropriate mitigation when controlled international shipments are the goal.

Reducing risk relating to regulation disparity

Local regulations dictate how the procurement, supply, import and export of medicinal products should be carried out in a specific territory and government bodies issue certifications and licences to show who has met the required standard. This is in addition to international treaties and mutual recognition agreements which help to determine which countries share equivalent standards or common objectives to each other.

There are generally at least three sets of regulations in each territory; those relating to medicinal products, those relating to customs/border control, and those relating to sanctions. You can find the information by searching online, ensuring you find a reputable government website, and/or by contacting the country’s medicines authority directly.

A company must fully understand the individual requirements of the locations they are shipping from/to, as it is difficult to verify a third party without understanding which licence is required, in a similar way that you cannot be assured you have the correct permits or documentation for import/export without knowing which law(s) the shipment is subjected to. Once you know this information, you can create a list to ensure you have the correct documentation and have completed appropriate verification of any third parties ahead of dispatch.

Every company that distributes internationally should have at least one standard operating procedure which details how your company will research and record checks on regulations, including any periodic updates which may occur.

Reducing risk relating to criminal interference

Physical security of products must be considered at every stage of the journey, as well as legitimacy of documentation when approving third parties (covered further below) and when reviewing documentation from the journey.

The level of security required during the journey should be proportionate to the risk of the product(s) being transported and the method of transportation used. For example, consider whether you are transporting controlled drugs and/or high value products.

Some ways to deter tampering or theft for road transport include having two drivers present at all times to ensure the shipment is never left unattended, and completing shipments the same day as much as possible. Using high-security seals with unique serial numbers may be required to assure that shipments have not been tampered with during a journey, and/or making sure areas are covered by CCTV during cross-docking or changeovers.

Additionally, criminal record checks for all employees should be considered, and the ID of drivers checked to help ensure an impersonator is not trying to collect products.

Reducing risk relating to storage conditions

Maintaining storage conditions of a product is difficult during international distribution, considering the number of stages in a journey and the differing climates and/or altitudes which might be encountered.

The best way to reduce the overall risk of temperature excursions is through proper route planning and monitoring. You can greatly reduce the likelihood of temperature excursions through sufficient planning of a transport lane before a product is dispatched from the manufacturing site. Likewise, you can ensure key stages are identified so that information is recorded and detectability of issues is increased.

You will need to determine whether active or passive temperature control is best, dependant on the size of the shipment, method of transportation and duration of the journey.

This is why it is important to work with a trusted, experienced logistics company who understands that you may need additional information before deciding on a particular route option and will remain patient while you complete a sufficient assessment of what is needed.

Reducing risk relating to the utilisation of third party companies

Unique risks relating to the use of third party companies are generally focused to the initial approval and verification of a company, as well as the fact that the product is outside of your direct care, meaning that detectability of any issues needs to be particularly maximised as much as possible.

Maximising the detectability of any risks that occur is key whenever a product is not in your direct care. For example, you need to consider how to maximise visibility of temperature excursions, or attempted/actual theft of product.

You must also consider the use of calibrated temperature loggers with appropriate recording intervals., When reviewing tracking or data logger information, consider the time differences at the time of the shipment to ensure you are accurately monitoring the temperature at each stage and you have correctly calculated the timing of events or any excursions/deviations.

Mitigating the risk of inaccurate customs declarations or delays during clearance

Assuring you have accurate customs declarations starts as soon as you have identified your potential target market; you need to know the classification of your product in its current location and its destination market.

When distributing internationally, a product is generally unlicensed in at least one of the locations; even if the product is authorised and QP released in its origin country, it is likely being imported by your customer as an unlicensed medicine in that territory.

You must consider:

Assuring you have accurate customs declarations starts as soon as you have identified your potential target market; you need to know the classification of your product in its current location and its destination market.

When distributing internationally, a product is generally unlicensed in at least one of the locations; even if the product is authorised and QP released in its origin country, it is likely being imported by your customer as an unlicensed medicine in that territory.

You must consider:

- Customs regime and procedure codes for the export declaration as well as the import declaration;

- Whether the commodity code is the same in all territories;

- Whether the product’s origin and movement is clear from the transport documents;

- Are incoterms clear

National holidays can also affect the timing of customs clearance. For example, if your shipment is due for delivery during a religious holiday period in the destination territory.

Conclusion

In the international market, everything has an additional layer of complexity. Decisions need to be communicated quickly, and across multiple time zones. But in a world where one decision can impact thousands of patients, it is important that adequate research and planning takes place ahead of a product being dispatched from the manufacturing site so that any known risks are mitigated ahead of its final destination – and before it reaches patients.

Sometimes a medicine won’t work for every patient, but what we as an industry can provide, is some assurance that medicines are available to patients and their prescribers at the quality intended by the manufacturer, and that everything is being done to prevent unintentional jeopardisation of product quality, even across the globe.