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A transport validation strategy


The best pharmaceuticals and medical supplies on the market are useless to patients unless they arrive at their destinations intact, unspoiled and on time.

The proper packaging and shipping of drugs, medical equipment and food for medical purposes has become a major industry all of its own. One of the top consultants in the field, Tobias Kuners of Koenders, managing consultant at Tob Management, a Netherlands-based consulting firm, advises small and medium-sized pharmaceutical and biotechnical companies to do sufficient work ahead of time to ensure they have the most effective shipping and transport validation strategy possible when their products leave the warehouse.

“Shipping and transport strategies and execution are often started late in the development of products,” Kuners of Koenders told Nordic Life Science. “Some of the elements of the strategy should be started early on, and have others already in place in the laboratory setting by gathering intelligence to help shape the actual validation with placebo and final product.”

Identify the most critical factors

When crafting shipping and transport strategies, patient safety is always the priority. The factors companies take into account in developing their strategies depend, logically, on the nature of their products.

“Tablets are less sensitive to temperature variations compared to liquids, and biologics are much more sensitive again,” according to Kuners of Koenders. “Biologics may also be more sensitive to vibration. Powders may be sensitive to becoming lumps when you want them to be fine powders. A good risk assessment with people from product development, quality, engineering and qualification should identify the most important and critical factors. When you make such assessments early on you can design your strategy to tackle the issues while going along the product life cycle.”

Plan in reverse

Companies should also work backwards from the commercial to the pre-clinical stage when developing strategies, Kuners of Koenders advises.

“A lot of first results can be obtained in the laboratory, testing stability; chemical and physical effects, UV, heat and vibration. Those results provide input to the actual transport validations that need to be executed with the actual products. Here, also, many trials can be tested with a placebo product.”

Depending on the stage the products are in – pre-clinical, clinical, phase I/II, phase III or commercial – they should grow to a more mature level of addressing the validation, according to Kuners of Koenders.

“To do that effectively, they need to plan in reverse. In the early stages, companies do not have resources to do everything, but for instance a stability study takes time and if they can start one early, they can gather data over an extended time, which will benefit them at the filing.”

If a company is close to launching a product and knows its first markets, it can have actual transport validation runs to those, Kuners of Koenders advises, but early on the company needs to develop an approach and work on those activities that need to be done in all cases, and use the results from the first markets in other areas with similar conditions.

Monitoring is essential

Some of the biggest challenges in developing an effective strategy are finding the right balance between the markets the companies want to serve, the transport modes to bring products to those markets, the risks identified and the money needed to perform such trials, according to Kuners of Koenders.

One of the trends in global shipping of which companies should be aware is the move to cold chain, with temperatures between 2 – 8 °C, or -20 °C for biologics, which require even more rigorous design and execution of transports, he says.

Monitoring products during shipment is essential, he adds.

“For temperature, data loggers are used; at least two per shipment, and usually more when a shipment is spread over multiple pallets,” explains Kuners of Koenders. “Two data loggers per truck is pretty standard, two per pallet for an expensive product or newly released product is not unusual. For products that are shock sensitive, shock indicators are common.”


Among the biggest mistakes enterprises make in designing their plans are cutting corners to save money, which can result in damaged products and lost revenue. While Kuners of Koenders said he is not aware of any reliable figures charting losses in the medical industry due to improper shipping practices, “From personal experience, I know that several million U.S. dollars per year is on the low end.”

Often, usually because the risk is not considered to be significant, and with cost being an issue, Kuners of Koenders notes that strategies may not be comprehensive enough, resulting in transport excursions for which there is not information about the resulting product quality, and hence, resulting in a loss of that shipment.

Questions to ask

When seeking advice from consultants or experts, companies should be certain to ask how they designed their strategy and which considerations have been taken into account; such as the regions they serve, which transports they use and how lab results have fed into the design of the transport validation protocol.

“Companies should look for a consultant who is knowledgeable on the subject, has done shipping and transport validations, and possibly packaging validation as well, as both are closely related. To limit exposure in shipping and transport typically the packaging is put to use.”