A Guide to Pharmaceutical Shipping Regulations

April 17, 2023

Pharmaceutical Transport

As if transporting products around the world wasn’t complicated enough, pharmaceutical transportation takes things to the next level. Just think of the challenges of logistics. You have to consider things like temperature control, expiry, careful handling, and potentially hazardous materials, along with all your other everyday logistical operations.

The nature of pharmaceutical products, like the COVID-19 vaccine for example, has led to the creation of industry-wide pharmaceutical transportation regulations that aim to standardize shipping practices to safeguard everyone involved. Those involved in transporting pharmaceutical products must keep abreast with these regulations as they are created and updated.

Types of pharmaceutical shipments

When you hear talk of ‘pharmaceutical shipping’, it really refers to how pharmaceutical products are transported from one place to another. There are three main ways to transport pharmaceutical products, each with its pros and cons.

Ocean shipment

Shipping pharmaceutical products via the ocean allows you to transport them in bulk while being relatively cost-effective. However, shipping products can take a long time and there are risks associated with the ocean such as ocean swell, storms, and many other factors that could negatively impact pharmaceutical cargo. Often, ocean transporters will use offshore reefers which are refrigerated containers that can be stacked and powered by the ship.

Road transit

This is the most obvious form of transport when pharmaceutical products need to be taken between cities, states, or bordering countries. Depending on the distance required, pharmaceuticals can be put into temperature-controlled containers and/or refrigerated trucks. While there are fewer risks than the ocean, there are still risks of traffic delays, theft, and damaged or malfunctioning vehicles to consider.

Air freight

Flying pharmaceutical products from one place to another is one of the fastest and most direct transportation methods, but it comes at a cost. Whether by airplane or helicopter, fuel is expensive and demand for air travel is high. Air travel is the obvious choice in medical emergencies.

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Regardless of the choice of transport, a focus on the integrity of the pharmaceutical product has to be maintained. Different products can withstand different time periods, temperatures, and handling conditions which is why product packaging also plays a big role during transportation.

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Different packaging materials offer varying degrees of protection, rigidity, cooling, and stability with each variable impacting the cost of packaging. For example, a temperature indicator label can be used to provide quick information. Transporters need to be aware of the product packaging being used and how best to handle and pack products to keep them in optimal condition.

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A guide to pharmaceutical transportation regulations

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Considering the importance of pharmaceuticals, it is no surprise that helpful regulations have been put in place for you to follow. These regulations help to protect all stakeholders involved and safeguard the cold chain against various challenges. The regulations can be summed up into these points:

Proper documentation

There are so many stopping points and variables along the cold chain that transporters need to be able to record key information along the way. Documentation needs to be filled in to record things like the product description, where the products have come from, what requirements they have, any incidents along the way; any and all information that will help you keep track of your products as they are transported. Correct labeling goes a long way in ensuring that products are dealt with appropriately.

Temperature control

Most pharmaceuticals can in some way be impacted by fluctuating temperatures. That is why the cold chain has to be tightly controlled according to the needs of the products being shipped. Temperatures range from cryogenically frozen, frozen, refrigerated, controlled room temperature, or warmed in some cases. Getting products to the correct temperature is one thing, but keeping them at the correct temperature through the cold chain journey is where the real work is done. Solutions like Varcode’s Smart Tag and Scanning Suite help to monitor and track the temperature of products along the cold chain.

Hygiene

One of the greatest threats to pharmaceuticals is contamination and/or damage. That is why hygiene and cleanliness are so vital at every step of the cold chain process. Hygiene includes keeping storage space and equipment clean, having the correct airflow, eliminating the growth of bacteria and mold, and creating a clear separation between products that are hazardous, damaged, or expired.

Safety and protection

Many pharmaceutical products are as valuable as they are impactful which is why they need to be kept secure at all times. Access to products needs to be strictly monitored and measures such as surveillance cameras, access-controlled doors, and proper lighting need to be put in place to limit the risk of theft or mishandling.

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Various organizations around the world have set out regulations for pharmaceutical shipping, which will apply depending on where you are operating. US and European transporters take guidance from the FDA and WHO.

Can the pharmaceutical shipping process benefit from automation?

As with almost every industry, automation has the potential to improve pharmaceutical transport processes to make them more consistent and efficient. The two areas of interest are warehouse storage and temperature control.

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Future forward warehouses are looking to use automation both in physical and software solutions. Warehouses that use robotics to transport and store products create a safer and more efficient environment. Warehouse management software also helps to take human error out of the equation by letting control algorithms monitor and manage the warehouse. Though many workers have been concerned that automated robotics will threaten their jobs, the reality is that automation merely shifts the focus from physical labor to operating automated tools.

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Automating temperature control at each phase of the journey also helps to ensure the integrity of the pharmaceutical products. For example, Varcode’s Management Suite automates the collection and reporting of temperature data into one platform, giving stakeholders the information they need to make decisions about their products.

The takeaway

Pharmaceutical regulations have been put in place not to make your life harder, but to help ensure that your products reach their end destination in their most viable form.

Explore how Varcode can apply regulations within your operations while streamlining your data collection and analysis. With technology like Varcode’s, you don’t have to simply meet regulations but look at ways to go above and beyond by automating areas of your process. Contact us today to learn more about how we can help.