When planning a cross country trip, it is important to carefully plan one’s route. Determining the most efficient travel path, avoiding construction delays, and determining overnight stopping points for sleep are all important aspects of the journey. Failing to consider any one of these could lead to exaggerated travel time and unexpected delays. When it comes to international shipping of pharmaceutical products, planning is equally, if not more, important than when planning a cross country trip. Delayed shipments could lead to compromised products and untreated patients. Taking the necessary time to work closely with clients and vendors in the shipment planning stage is one way that Singota mitigates the risk of in-transit delays.
Not too long ago, a client of ours had an urgent need to ship an investigational drug to a clinical trial site in a foreign country, and adamantly insisted we rush the shipment out the door as soon as we possibly could. Accordingly, the material was scheduled to ship the next day. We had met our client’s requirement. Unfortunately, that meant the product left our GMP facility without our carrier’s assurance that the shipment had been pre-screened by our broker in the country of destination. You probably can anticipate where the story goes from here.
The material sat in customs for over a month. We learned that our client had not obtained the correct import permit, and applying for a new one could take up to four weeks. In fact, once they had the right permit, the material still sat for almost two months. There was a strike going on in the country receiving the shipment, so the material still couldn’t be delivered. After 11 weeks, the material finally reached the trial site.
Unfortunately, while this was an extreme case, it is not the only instance where a client request for “rush” shipping to an offshore destination has led to bureaucratic misunderstandings and unfortunate delays.
Clients will sometimes request that we shorten the lead time to get their products to overseas sites on short notice. This is understandable. Trials have to be scheduled, and shipping requests can be delayed for any number of reasons. As a specialized CDMO, we need to be prepared for urgent requests, last-minute changes, and unorthodox requirements. That’s the nature of drug development and testing! Expedited shipping is one of the ways a company like Singota distinguishes itself.
It might seem fair to assume that expedited shipping applies only to the act of preparing and tendering the product to the carrier. While some may rate their success on this type of metric, we emphasize expediting the complete delivery process. Clients may assume that rushing the shipment out of our facility today will get it to its destination faster. For international shipments, however, that often is not as simple as it sounds.
We have an established internal procedure for international shipping, in which we try to give ourselves enough lead time for all the official paperwork to be generated and vetted. This aids in allowing our client’s material to experience smooth transit through customs. If the material is shipped using a specific type of container, with a specific temperature control, there is a maximum amount of time that it can be exposed to ambient storage. Time is always of the essence, but never more than when dealing with temperature controlled products.
Customs regulations in all countries require specific documentation that isn’t needed for domestic shipments. Our procedures are designed to give us the time to gather all the data we need to satisfy the customer’s product-specific requirements for the country we are shipping to. We may have the data on file, or our Client Services team may have to get it from the drug company whose material we are shipping.
The documentation requirements can be voluminous. What is the Schedule B export number? What’s the Harmonized Tariff (HT) code? What import permits are needed for this destination country? Is the description of the product being shipped sufficiently detailed? Does the product value direct that additional requirements are met? These are the kinds of questions that come up in our planning dialogue with the carrier. Ideally, at the end of the dialogue, which may take a couple of days, they will tell us, “You’ve got the ‘green light’ – when can we pick it up?”
Once we have all the data, our procedure calls for us to send it ahead to the customs brokers for pre-screening of the shipment. There is no formal pre-clearance process – customs can always choose to inspect a shipment. But we can ensure that, between our own diligence and that of our carrier, we have done everything we can to provide complete, accurate paperwork.
If the customs brokers see any issues in the documentation, they can let us know before our client’s material ever leaves the security of our warehouse. The sooner we can address these issues, the better — but more importantly, if there is any hold up in a shipment, especially a temperature-controlled shipment, the best place for the material to be stored is in our warehouse. To have sensitive materials sitting on the dock somewhere out of our control, waiting for clearance, is exactly what our procedures are designed to prevent.
We need to be certain that the shipment paperwork will not sit on someone’s desk, where we have no control over it, for days until it gets approval. Customs can open shippers for inspection — that can impact the effectiveness of the shipping solution and create excursions (where temperatures to which the material is exposed get outside the acceptable range). That is much less likely when the shipment has been pre-screened. A shipment with incomplete documentation would get much closer scrutiny.
Another factor that affects the lead time and shipping is the type of shipping solution we choose. Depending on what we are shipping, we may use a container that we have in inventory. Or, we may rely on the carrier to recommend a specialized shipper, which we will obtain from them. Getting that shipper prepped and sent to our site for packaging may require time.
And, there is the fact that we are shipping to a foreign country with its own culture. We have seen shipments delayed because the resources we needed to rely on in that country were unavailable because of a holiday neither we nor the client had anticipated.
The moral of the story? Shipping sensitive drugs internationally is a complicated dance. Our metrics for success are different from those of an airline, whose “on-time departure” statistic is based on when the plane pulls away from the gate – not when it leaves the ground. For our client, and for us, it doesn’t matter so much when the product leaves our warehouse. What matters is when it arrives at its destination. The question isn’t how fast we can pack a container; it’s how fast we can secure customs clearance.
Shipping is one element of Singota’s Supply Chain Management service offering. To learn more, visit our supply chain page.