Beyond Compliance to Excellence
Planning and performance for cell and gene therapy logistics
In our most recent article, we discussed the real-world complexity of transporting gene and cell samples and therapies from clinical to manufacturing to administration site and patient on time, at the correct temperature, and in perfect condition, every time.
When planning clinical trials or therapy production and administration, therefore, it’s vital to choose a logistics partner that is up to the task, has a successful track record and can demonstrate how they achieve those results.
Logistics not only covers a lot of ground, in terms of physical delivery, but also in areas of responsibility. In our new e-book, Tomorrow’s Medicine: Curing One Patient at a Time, Dr. Ruediger Lomb, World Courier VP for Global Quality & Technical Compliance, explains it this way:
“Acting as an extension of the shipper from pick-up through delivery, a qualified GxP-compliant logistics partner will deliver the required service basics – an uninterrupted chain-of-custody during transit according to established global SOPs. This, however, is the minimum of expectations when it comes to managing these shipments….
“Knowledge of not only GDP [Good Distribution Practices] but also cGMP [Current Good Manufacturing Practices defined by the US Food & Drug Administration] is key, as it is not only adhering to existing regulations, it is anticipating potential bottlenecks in the manufacturing and supply chain, and preparing for the unexpected. Clinical teams, therefore, should be seeking ‘quality beyond compliance’ operationally at the global level…”
What should you expect from a logistics provider? According to Dr. Lomb:
- A dedicated cross-functional project team able to consistently manage the intricacies of these shipments globally,
- Study-specific SOPs and work instructions applied globally,
- Mandatory pre-trial training and credentialing for all personnel globally who come in contact with the shipments: clinical staff, investigators, logistics personnel and external suppliers,
- Public and industry outreach to other key stakeholders, such as customs agents and airline personnel, to assure that everyone understands what is at stake — also globally,
- Unrelenting attention to detail from people who can and will think outside the box, and
- Oversight and continuous assessment by company leaders.
“Compliance can be obtained by strict adherence to SOPs,” he concludes, “but Quality can only be obtained by engaging all major stakeholders both inside and outside the supply chain on a shipment-by-shipment basis. That role falls on the logistics provider.”
For a detailed explanation of how World Courier designs logistics for global clinical trials, including defining study parameters and our four-part project management system, please download our e-book.