Cold Chain

Industry Viewpoints: Maintaining the Product Integrity of Pharmaceuticals

Cold Chain

13:00, December 7 2017

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Francisco Rizzuto, Cargo Specialist, IATA, discusses the role of the air industry in relation to the product integrity of pharmaceuticals

In this Industry Viewpoint, CTA Staff Writer Sarah Fal explores the increased interest pharmaceutical companies have in the air cargo and aviation industries. Over time, what’s become apparent is an information gap between the two industries that needs to be closed.

Fal speaks to Francisco Rizzuto, a cargo specialist with the International Air Transport Association (IATA). Here, he explains what needs to be done to ensure the integrity of products is maintained throughout the distribution process.

Sarah Fal: Can you provide me with some clarity on what IATA does within pharmaceutical logistics?

Francisco Rizzuto: IATA provides guidelines and certifies logistics companies involved in the air cargo of pharmaceutical product shipments. This relies on a specific auditing and training process based on existing regulations (i.e. GCP and WHO’s Annex 5) adapted to the air cargo industry, creating global international standards.

SF: What implications might there be for air cargo companies when making these shipments?

FR: Cargo companies sometimes have issues surrounding temperature controlled shipments, which can have a costly outcome. If this is the case, products cannot be distributed and must be destroyed or recalled. As a result, several parties, including pharmaceutical companies, lose money and customers.

SF: Who takes blame when this happens?

FR: This can lead to a complex legal claims process. The blame is sometimes attributed to the airline or freight forwarder. Therefore, conflicts can arise between multiple parties. At IATA, we are focused on improving pharmaceutical shipments within the cargo industry.

SF: What kind of discussion do you think the industry needs to engage in to avoid these issues?

FR: There needs to be greater clarity and an exchange of information between all stakeholders within the industry. This includes airports, airlines, logistics operators, and pharmaceutical companies. Airlines should explain how they treat claims when the integrity of products is compromised, while pharma companies equally share their experiences. It is also important to discuss the importance of visibility during shipments. There are times when pharma companies are unsatisfied with the visibility of their shipment during transit.

If deviation happens at one point in transit, they need to know immediately when that deviation happens in order to resolve any issues this may cause. This will lead to a solution that is technology focused. There are some devices, such as data loggers that give real-time readings during the full transit operation. Some airlines are testing how they can provide real-time visibility online during flights to their customers. They have data loggers on board which use Wi-Fi. This transmits what is happening on the aircraft.

SF: What regulations should the industry consider in relation to transport logistics?

FR: There’s a new serialization regulation coming into effect in the near future. This will allow pharma companies to have full control of their products from the manufacturing site up to the end user. There is a very close link between serialization and visibility.

In turn this will facilitate temperature maintenance as pharma companies can monitor what is happening to their products from start to finish. This regulation should come into place in Europe by February 2019. But this is also linked to avoid counterfeit of pharmaceuticals.

SF: How does serialization work?

FR: I’ll illustrate in a hypothetical example. Let’s imagine a pharmaceutical company detects that the temperature of certain products have deviated. This would have to be reported to the import/export country depending on where the deviation has taken place. They would then have to send a sample batch to the lab and test if the integrity of the product has been compromised based on its stability profile.

After these tests, they will either be given the green light or red light on whether the product can be distributed. Serialization comes in as an effective tool to trace where this deviation has happened, which can help influence whether the product can be distributed or not. But again, remember that is also a tool to avoid counterfeit.

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