As more drug companies go global, reliable product shipping becomes more complex with many third parties involved. Andy Hughes, commercial director, Pharmafreight, looks at how logistics companies can minimise the perils of international freight
Throughout my career in logistics, what we as freight professionals do has stayed the same - i.e. moving boxes from A to B, and the majority of the perils faced by cargoes haven't changed either. What has changed is the focus from pharmaceutical shippers and regulators alike on such movements, bringing about a marked change on what companies now want from their chosen logistics provider.
As little as five years ago a large percentage of the world's pharmaceuticals moving internationally were travelling around with little control in place, transferring from one general cargo warehouse to the next, being exposed to all sorts of risks such as extreme temperatures, theft and substitution, contamination and many others. And it would be naive to think that the situation has changed dramatically today, with all such issues having gone away through better run supply chains and technology.
However, what has changed - and is continually changing - is both the logistics and pharmaceutical industries' awareness of what challenges are facing products on their journey, and the willingness to adapt new procedures to ensure these challenges are kept to a controlled minimum.
One of the historic common logistical misunderstandings by phamra companies shipping products is the assumption that the carrier they release their neatly packed product to will be the company which delivers it to their customer's door, across the other side of the world on a different continent. A more realistic scenario is one where they would book a collection with their local forwarder, which would then collect it on its own vehicle (along with any other general cargo it was collecting from other non-pharma customers that day) or may sub-contract that job out to another haulage company which would carry this task out on its principal's behalf.
Their product would then travel to the forwarder's warehouse, where it would be stored in a general cargo environment - neither temperature controlled (warehouse temperatures can reach 40ºC during summer months) nor segregated by commodity - until the time came time to ship the consignment via its chosen method, let's say - for the purposes of this example - by airfreight.
The consignment would then be delivered (possibly by the forwarder's vehicle or maybe by another sub-contracted haulier) to the airline's general warehouse. I say airline's warehouse, however a large majority of airlines have now contracted out of handling operations at airports, with third-party warehousing companies now employed to store, load and unload their aircraft. Again, in general terms there will be no temperature or specific controls within these warehouses.
The airline would then instruct the warehouse to load the goods onto the appropriate flight and with a bit of luck - and depending on the carrier you have chosen and the rate paid - your product will fly on the booked flight. On arrival at destination, the same chain of sub-contractors and agents will apply, but in reverse.
What you can see from this is a system which is fine for the majority of cargo being shipped around the world, however, there are certain products, such as pharmaceuticals, that require a much greater level of control to ensure a shipper is able to demonstrate its product has been protected from changes in its characteristics during its journey, to the best of the shipper's beliefs and actions.
For many pharma companies, it is therefore no longer acceptable to just book their precious consignments with a local freight forwarding company and hope they send it out in the correct manner. Can they be sure that every forwarder understands it becomes their responsibility to ensure the characteristics of a product are unchanged by any actions - or the actions of their sub-contractor - during the international movement?
As a result of this reality, there is now a move to look for more specialised forwarders, one perhaps operating with its own Wholesale Dealers License, operating to Good Distribution Practice (GDP) within its own activities. It must be appreciated, however, that even these companies will need to release the cargo out of their care when it comes to, for example, shipping via airfreight, as in general such companies will not be operating their own aircraft, and these would certainly not be run to GDP standards.
The end result is an understanding that in reality there may be many parties within the supply chain, and all have to be involved at differing levels to agree to operate to Standard Operating Procedures (SOP) and written agreements, perhaps chosen because they have already embraced the intricacies of the pharmaceutical supply chain.
Specialised forwarders must employ the use of other suppliers and agents that also employ GDP practices for the whole chain to be unbroken, and this means in the overseas markets too. Pharma companies can then feel more confident when releasing products into the supply chain that they are moving from one regulated environment into another, with no break in the GDP chain from their operation to the end user
Many pharma shippers no longer seem confident to leave what can potentially be a hazardous part of a product's life to chance, and now demand much more information on routings, parties involved in any one supply chain, and possible issues faced en route. Auditing of logistics companies are much more commonplace now, with principals wanting to verify exactly how their goods will be handled by any chosen supplier.
Specialised logistics companies or divisions of larger forwarding companies are now being created to answer some of these questions and work on the answers. Such companies become extensions of their own customers' pharma supply chain, operating to strict SOPs governing what happens to specific products and destinations.
Risk assessments are being conducted on new routes and products to identify any hazards that shipments may face en route to perhaps a new customer. Route qualification is also a new focus, gathering information about what happens to a consignment on its journey from A to B. Today, there is a much better understanding of the perils products face, and an understanding that many are hard to control (e.g. weather, manual handling), however, if all parties can be made aware of potential problems, then SOPs can be raised and systems put in place to limit exposure to these issues.
That said, some manufacturers do not have the financial capacity, know-how or resources to examine their shipping routes as other more global pharma companies do. And it is this type of company which increasingly looks to a specialised pharma logistics company for routing advice, packaging information and provision, route qualification. They also take as a given all the other provisos, such as security, control, appropriate training, suitable premises and procedures in place, without them having to be involved in helping to create this environment.
Such shippers now look to logistics companies that can provide logistics solutions for their product, and ensure the chosen route is qualified, and all operates to a GDP standard - all included in the price being paid.
There are also signs now of certain parts of the pharmaceutical industry looking to logistics companies to provide solutions on temperature-controlled packaging (TCP). We have all seen the prolific growth of this industry in past years, with many new suppliers coming up with new ideas and technologies to ensure a controlled temperature and secure environment is maintained on a product's journey. There are lots of new products out there and it does take time to examine all the possible options for a company. With airfreight temperature-sensitive shipping forecasted to grow at 15% per year, you can perhaps see why.
We have also witnessed an increasing focus on this part of the supply chain from the regulators too, with the UK Medicines and Healthcare products Regulatory Agency (MHRA) highlighting the issues more and more, and the USP1079 guidelines being published in the USA. Several years ago their scrutiny was concentrated on storage conditions within warehousing at the manufacturer and distributor, however with a greater understanding of the international supply chain, the regulators now want to know what conditions and temperatures thermolabile products face on their way to the end user.
Pharma companies which lack resources are increasingly enlisting the help and expertise of the specialised pharma forwarder, which has perhaps already been through such investigational processes for certain products, temperature ranges and trade lanes, and already has off-the-shelf TCP solutions which can fit their products.
Ultimately, the boxes are still moving from A to B, however the logistics industry is now under a much bigger spotlight from the pharma industry, with old practices and systems being challenged at every turn. Customers want to know exactly how their products are being handled, by whom, and what systems are in place to ensure characteristics of the product stay the same, and logistics companies must be able to demonstrate this to their customers through the used of specialised distribution chains in order to compete for and win new business, and of course retain the old business too.
The challenge for the logistics industry is to accept it is no longer appropriate to expose pharmaceutical shipments to those experienced by other more general cargoes, and do everything possible within each supply chain to limit the perils faced.
A UK manufacturer recently won a new contract to supply insulin to a distributor in Canada. Insulin needs to be kept between 2-8ºC, and the manufacturer did not have experience in shipping goods internationally while maintaining such temperatures. Having read about Pharmafreight and its operations conducted under a quality system called Good Transportation Practice (GTP), which mirrors the GDP guidelines, it asked them to suggest a shipping solution for the product, including any packaging required.
Reusable packaging such as an Envirotainer was considered unnecessary due to the small amount of product being shipped, so a disposable packaging solution was sought, which would use ice plates (non hazardous for transport by air) to maintain temperature within the required range. The shipper mocked up an exact replica of their product's box, in which the insulin would need to be packed and moved. Pharmafreight then investigated a possible packaging solution that would accommodate such a box.
A risk assessment was carried out on the possible routings, and a direct carrier was chosen, one with experience in handling pharmaceuticals, with a specific express service on offer. Once a suitable TCP solution had been found, vials filled with water approximate to the size and volume of a typical shipment of real insulin were packed inside the product carton. The TCP was then delivered to the shipper and conditioned over a weekend. The shipment was prepared to a specific SOP on Monday morning, with temperature-monitoring devices placed inside and outside the package. The shipment was picked up on a GTP-compliant vehicle, and shipped on a GTP-compliant airline, through to Canada.
Pharmafreight's office, which cleared the consignment through customs, then delivered the consignment to the importer, all under GTP.
All of the temperature information from the data loggers was collated and reviewed to see what temperatures the product had encountered and whether the carton had maintained the required temperature. The ambient temperatures were also noted, creating a record of what could be expected at that time of year.
A second dummy test was conducted to double-check the initial findings, and offered to Health Canada as a suitable routing and system for the products to be shipped. An agreement was given by all parties concerned and a protocol and SOP were devised for the upcoming shipments with real product, and carried out accordingly.