With our biopharmaceutical manufacturing clients, we have noticed that companies have traditionally adopted a passive stance on last mile logistics, which has inadvertently resulted in procedures that could put compliance and patient safety at risk. Smaller manufacturers, in particular, are heavily reliant on partners who may not have a deep understanding of, and consequently do not adhere to, their specific product packaging and shipping requirements. This can increase the likelihood of temperature excursions or other risks during the transportation and final storage of the products.
Furthermore, existing regulatory guidance lacks precise delineation of accountability for logistics down to the last mile. The absence of a clearly defined chain of responsibility can result in dire consequences, including life-threatening situations. For example, consider the potential for product misplacement; delaying the receipt of products may result in said products being exposed to unsuitable environmental conditions.
The absence of a clear resolution on who should tackle and resolve the issues that arise during last mile logistics also poses a substantial threat to both the integrity of the product and the safety of patients receiving the product. However, it’s important to note that any violations observed during an agency inspection will be considered the responsibility and liability of the manufacturer rather than the distribution partner.
Given these considerations, it is imperative for manufacturers to take an active role in ensuring product integrity even beyond the point of their ownership, especially during the last mile of the product journey.
In our role assisting manufacturers with last mile logistics, we often advocate for increased manufacturer involvement by implementing the following best practices:
- Manufacturers should exercise careful consideration and due diligence when selecting a last mile logistics partner to ensure alignment of the partner’s distribution strategy with the manufacturer’s strategy and to understand the partner’s track record in adhering to required shipping conditions.
- Evaluate not only the partner organization’s current capabilities to adhere to your immediate product specifications, but also their long-term capability to meet your evolving last mile needs.
- Closely monitor delivery performance by conducting regular check-ins with the delivery partners. It is crucial for manufacturers to design performance metrics that ensure products are handled and transported with the proper level of care and adherence to specifications.
- Strive for transparency with your distribution partners, especially in the event of temperature excursions, alterations in the chain of custody, or deviations from established procedures.
- In dealing with last mile distribution partners, often Specialty Pharmacies (SP) or Specialty Distributors (SD) protect product integrity through the establishment of Master Service Agreements (MSAs) and submission of the Healthcare Distribution Alliance (HDA) filing form.
In our previous work with a clinical-stage biopharmaceutical company, the manufacturer conducted qualification studies to assess the shipment process from their 3PL provider throughout the U.S. before the actual shipment took place. The drug product was a liquid, shipped at 2-8°C using a passive unit at the next-day delivery. The manufacturer selected five regions within the continental U.S. to ship the drug products under varying temperature ranges during the winter and summer months.
This real-world simulation allowed the company to evaluate their selected shipping solution, thereby addressing any potential risks or challenges that might arise during the actual shipment process. Furthermore, it reaffirmed the ability to maintain the desired temperature range within the distribution network.