How well are we cooperating in the industry? That’s the question posed by FlyPharma US guest panelist Pelican BioThermal’s Ira Smith. Here he shares his industry insight relating to the conference topic: When it comes to temperature control and monitoring for pharma products, have we reached a point where we are getting it right most of the time, or is there more work to be done?

In my opinion we are getting it right most of the time; however, there’s work to be done. When temperature excursions occur, it’s not only a question of why they’ve taken place but where?

We cannot point the finger of blame to one particular actor in the supply chain. It often has to do with a pure and simple lack of coordination. We know where the ‘hand-off’s’ and the touchpoints are. Historically, we know where the danger zones are. Many tend to be at airport tarmacs, where shipments are waiting to be loaded or off-loaded, customs hold, human error around active container handling, etc.

Once the plane lands and the cargo doors are open, the payload is now exposed to the environment and it can take 2-4 hours to unload an aircraft, depending on the efficiency of the handling company. As stated, we know the critical points where we see temperature excursions. They are at airport tarmacs, unconditioned warehouses and on non-temperature-controlled trucks. However, we can’t just blame the airlines or truck companies. We realise it’s a complex chain of events and several hand-off points in the supply chain, which beckons the question of how well are we truly cooperating within the healthcare industry?

When we ask if there is more work to be done, I would say absolutely “Yes”.  I would challenge the industry and the working groups at the FlyPharma Conference US, to take a very hard look at walking the walk as opposed to talking the talk. We all talk about cooperation but how often do we all sit in one room with the packaging companies, the logistics providers, the QA and logistics people at the pharma company, with the goal of mapping out the hand-off processes? Are we making sure SOPs are in place for each hand-off?

Of course, each service provider can only be responsible for their portion of pharma logistics supply chain. We all strive to produce the best quality product and service. However, the initial planning is most important and that’s why I suggest that everyone literally sit down together to discuss what their products and/or services offer; at which points do they engage. Mapping out all the points where those services hand off to one another. Often time the ‘control tower’ will reside with the logistics provider.

Together with key stakeholders, all key service providers should map out a step by step logistics and hand-off process. To achieve this goal, someone needs to take a leadership role. I believe that taking a more active stance will ensure a more successful journey from the point of manufacture to the point of delivery.

In recent years, the temperature-controlled packaging manufacturers have made tremendous progress, coming up with more advanced insulation, more efficient design, as well as cost-reducing reusable systems. Airlines have made a tremendous investment in new facilities that are dedicated to the handling of pharma product.

Global freight forwarders/3PLs, have also made tremendous investments in temperature-controlled warehousing, establishing specific vertical teams and setting procedures and GDP-adherent guidelines within their networks. All of these business investments have been key elements in driving excursions down from year to year.  Two key factors that still remain most responsible for temperature excursions, are often human error and poor communication.

I challenge my colleagues in the other parts of the supply chain to create an environment where there’s more cooperation and communication. This starts from the very beginning of a project with the pharmaceutical company. It’s critical to get everybody on board and map out a process and design a logistics system and then walk that system. This starts from point of manufacture, all the way to point of delivery, including post-delivery.

Many of the current industry guidelines target the maintenance of specific temperatures and specify structure and facility in the supply chain.  However, seldom do current regulations suggest and/or dictate that there’s a specific organized layer of cooperation between all vendor parties. They may assume that it’s just common sense. As a wise old mentor once told me, “Common sense is not terribly common”.

In my experience, very seldom do you have the airlines, the freight forwarders, the packaging company’s and the client along with QA all in one room. The trick is maintaining a system of communication between all key stakeholders including manufacturer, distributor, transport packaging providers, airlines and 3PLs.

We are not here to compete with one another. We need to be part of a team that views the pharma supply chain as a series of hand-offs from teammates and making sure this orchestra is playing off the same sheet of music.

Hear more from Ira Smith and his fellow panelists in ‘Temperature control and monitoring for pharma products’ at the FlyPharma Conference US ( 11-12 September 2018, Miami, Florida).