Article: How to mitigate supply chain risks when undertaking a clinical trial

A number of steps can be taken at the planning stage for a clinical trial to minimize the risk of these complications from happening, and to reduce their impact:

• Understand the regulatory environment

Before any planning takes place, it is vital to have an in-depth knowledge of the global regulatory environment the CTM will be transported in. Understanding all of these regulations can help ensure that any supply chain is planned with compliance in mind, no matter how complex it needs to be.

The key guidance to be aware of (among others) are:

1. European Union (EU) Guidelines for Good Manufacturing Practice (GMP) for medicinal products for human and veterinary use
2. European Commission (EC) Guidelines on Good Distribution Practice (GDP) of medicinal products for human use
3. International council for harmonization of technical requirements for pharmaceuticals for human use guideline Q9 on quality risk management
4. USP 1079 good storage and shipping practices for drug products

•        Carry out a general risk assessment

One key takeaway from guidance for clinical trial sponsors looking to transport their CTMs to patients is the importance of quality risk management, and the need for a general risk assessment on the transportation processes. EU GDP Chapter 15 and ICH Q9 both offer recommendations for an evidence-based approach to assessing the risk of issues impacting on the secure delivery of CTM, providing a four-step approach:

1. Risk assessment
2. Risk reduction and control
3. Risk communication
4. Risk review

An expert logistics partner can provide advice to ensure any required risk assessment is comprehensive and compliant with local regulations, in order to meet the guidelines.  

•        Perform a lane assessment

A key part of any project to categorize general risk is the undertaking of route mapping and a lane assessment - plan of the chosen transport route and a review of the unique risks associated with them. 

For example, if transporting CTM by air, then it is important to consider the risk of the product waiting on the tarmac for an extended period. It may also be necessary to evaluate the potential for damage to the packaging during loading and unloading. 

In many cases, it is possible to eliminate risks through the use of qualified freight partners who have experience handling sensitive cargo, and via the selection of appropriate packaging. An ideal container is one that has been tested to maintain a consistent internal temperature for an extended period of time in extreme external conditions and is designed to withstand storage damage. The planning of an alternative route can also help minimize the risk of delivery delays. 

•        Remember the Customs clearance process

It is possible to minimize any delay from Customs clearance by ensuring all relevant documentation is complete, up-to-date, easy to hand over and pre-approved by the destination. 

This paperwork should include anything relating to the importation of material. Documentation demonstrating the product has been stored consistently in the required temperature and environmental conditions, as well as verifying chain of custody, is also important. 

In addition, should authorities wish to visually inspect the product, whenever possible, it is worth considering how to package, and open and close the container as quickly as possible to reduce delays and to prevent temperature excursions within the box.