World Courier, a recognised leader in speciality logistics for global clinical trials, discusses the importance of adopting a robust and flexible risk management strategy for transporting pharmaceuticals in light of forthcoming regulation.
Sending pharmaceuticals out of a safe storage facility into the big wide world is a frightening prospect, particularly since it's not just the finished product we now need to be concerned about: from 21 September, manufacturers and distributors of APIs must show full traceability throughout the supply chain, and from March 2016, excipients will be subject to a full risk assessment. Businesses face many potential problems, including:
It is not possible to control all these things, but it is possible to work out how likely it is that they will be a problem and prioritise responses to them. Risk assessment is increasingly used to gauge the competence of shipping departments, freight forwarders, couriers and third-party logistics providers prior to sending high-value pharmaceuticals. This is particularly the case for clinical trial items, personalised medicine supplies, and biologics with their tight temperature ranges, limited stability data and limited resupply options.
Every step of the shipping process can be considered and each area of a business can give input on risks and control measures. One of the benefits of adopting a risk management strategy is that, used well, it empowers employees to identify likely problems and solutions. Over time, this results in a risk-aware culture and encourages participation at all levels.
Using this approach can be particularly useful when sending materials into newer, emerging destinations. These offer considerable opportunities for patient recruitment, but there are new and interesting risks associated with them.
A lot of these are cultural or involve specific local regulatory requirements. Risks can be mitigated by having local knowledge, local representation and local staff, or working in close partnership with a company with extensive experience.
Infrastructure challenges abound when it comes to global transport and they're often in unexpected spots. Storage varies within regions too. While local regulations are evolving all the time and shipping becomes a little easier, shippers certainly should not expect standardisation for customs clearance or regulatory relationships, especially for pharmaceutical products. One reason for this is that the 'language' of pharma, from ingredient names to scientific terms, cannot be easily translated and without translation a lack of transparency in clearance processes continues to be an obstacle.
It is possible to circumvent almost anything if you are prepared to spend a great deal of money on shipping, chartering flights, using hand carriers and flying people to remote destinations, but these are normally extreme measures. Perfection can be achieved, but is a very expensive commodity and so a balance must be struck.
US Second World War General George S Patton said:
"Take calculated risks. That is quite different from being rash." Putting in place a risk management strategy enables you to follow his advice, and will allow your business to evolve to fit with a changing landscape.