If you have a cell-based therapy in development, there are several variables and best practices to consider before you begin to prepare the Investigational New Drug (IND) submission to the Food and Drug Administration (FDA). These variables may include packaging, storage, inventory management, monitoring systems, distribution, and even clinical site capabilities. Fisher Clinical Services' blog, entitled Insights Online, recently featured a two part blog series that identified the Best Practices for Managing Cold Chain Shipments. In total there were 8 comprehensive steps that advised readers on ways to ensure their products' integrity throughout the cold chain logistics shipping process.
Our end-to-end cold chain solution allows our customers to ship their products at a wide range of temperatures, ranging from ambient to cryogenic. Before scheduling your next shipment, take a moment to answer the questions below. By understanding how these questions apply to your products, we can work together to ensure the best practices for managing cold chain shipments are followed.
Where is your product going?
Before your product reaches its final destination it may be handled by several people at multiple sites. It's important that you develop a distribution and tracking plan to understand the chain of custody and how your product will get from Point A (pick-up location) to Point B (final destination).
Who will transport your product?
After you've mapped out your distribution plan, it's time to select a courier to transport the shipment of your product. When selecting a courier, you should consider the nature of your product, delivery time, delivery location (international or domestic), and budget. The best way to ensure you are selecting a courier that can meet your needs is by conducting an audit. This will help you identify if you require an integrator or premium courier, and give you insight into the courier's internal quality systems, facilities, infrastructure, and ancillary equipment.
What type of packaging solution does your product need?
Now that you have selected a courier that meets your requirements, it's time to determine which cold chain solution packaging is most applicable for your product. Depending on the storage temperature and duration of the product's journey, there are various options that range from single use, low cost, to multi-use, high end passive solutions. It's important that the correct packaging is selected for your product to ensure it maintains integrity and efficacy throughout the shipment.
Who is your Importer of Record (IOR)?
Throughout your chain of custody, it's imperative that the shipment of your product complies with local laws and regulations. As explained in part two of the Best Practices series, by selecting your IOR you are "ensuring the imported goods comply with local laws, regulations, filing a completed duty entry, associated documents, and paying the assessed import duties and other taxes on those goods." Since the IOR is the entity legally responsible, they can communicate directly with customs and prepare necessary documentation to assist in smooth transportation of your shipment.
Why did your IOR appoint a Customs broker?
In certain instances the IOR can appoint a Customs broker to act on their behalf. The IOR is still legally responsible for ensuring the imported goods comply with local laws, but they may appoint a Customs broker to prepare all documentation for submission to Customs and work with local government to address unresolved issues. The broker may also be responsible for calculating the payment of taxes and/or duty.
Which International commercial Terms (Inco-terms) apply to your shipment?
Inco-terms are widely used in clinical trial shipments, specifically Delivered at Place (DAP) and Delivered Duty Paid (DDP), and help to identify the responsible parties throughout the shipment.
- DAP identifies the exporter as the responsible party for delivery of goods to a named place in the country of destination. In this instance, the IOR is responsible for Customs Clearance formalities and duties. The Importer has the option to reclaim payment of tax in countries where permitted.
- DDP identifies the Exporter as responsible for delivery, payment of duties, and/or taxes. The IOR is only responsible for Customs clearance formalities, but will not have the option to reclaim tax even if permitted in the importing country.
Is your product's final destination in Europe?
If so, you may require the role of a Qualified Persons (QP). A QP serves as the eyes and ears of the UK Medicines and Healthcare product Regulatory Agency (MHRA). Their primary focus is to protect patients by ensuring that medicinal products have been manufactured and handled according to GMP and European Union regulations. By protecting the patient, QPs also serve to help and protect the manufacturer. To learn more more about the role of the QP, the requirements of the MHRA, and ways to ensure the commercial success of your product in the EU marketplace, download our eBook QP Essentials: Your EU Gateway to Clinical and Commercial Distribution of Cell Therapeutics.
Are you actively tracking your shipment?
By utilizing a real-time tracking system you will have a better understanding of where your shipment is in the chain of custody process. If a problem or delay arises, you'll be able to identify your shipment's location and potentially work with other parties to come to a resolution. Additionally, detailed courier transit performance reports allow you to maximize cost and performance, while mitigating risk across the chain of custody.
By taking the time to answer these questions, you are one step closer to ensuring the integrity of your product throughout the cold chain logistics process. To learn more about important factors to consider when shipping products, download our eBook Commercially Successful Cell Therapies: Navigating the Ultra Cold Chain Distribution Minefield.