The WFH Humanitarian Aid Program supports countries with limited access to care through donations of factor and non-factor replacement therapies, both of which entail complex logistical challenges. The overall process is managed by the WFH Humanitarian Aid Program team using the WFH Quality Management System (QMS) and Standard Operating Procedures (SOPs). The QMS is the framework of policies, processes, controls, and documentation used by the Program to ensure that donated treatment products are handled, stored, transported, and distributed safely, consistently, and in compliance with regulatory and quality standards. SOPs are detailed written instructions that describe how specific tasks must be performed. The WFH uses dedicated freight forwarders—including Kuehne+Nagel, DSV, and Logenix International—to ensure that SOPs are adhered to throughout the logistical process.
The delivery of donated treatment products begins with strict compliance with national and international regulations. Countries receiving donations often require import permits, certificates of analysis, and various regulatory approvals before products can enter the country. The WFH Humanitarian Aid Program follows World Health Organization (WHO) guidelines and Good Distribution Practices (GDP), ensuring that every shipment is managed through a comprehensive quality management system designed to maintain product quality and patient safety. In some countries, additional requirements such as pre-shipment inspections (PSIs) and documentation reviews are also necessary.
A significant amount of documentation is required before treatment products can be shipped. Commercial invoices; packing lists; airway bills; Certificates of Pharmaceutical Product (CPP) or Free Sale Certificates; manufacturing details; lot numbers; expiry dates; import licences; and customs declarations must all be prepared and verified. These requirements vary from country to country and are needed to ensure that donated products move smoothly through customs and regulatory processes.
Customs procedures differ significantly between countries and can sometimes result in delays. Incomplete paperwork, inspections, or administrative requirements can slow shipments. One of the last steps in the process is the validation of the shipment’s temperature by a WFH Compliance Specialist to ensure that it was within limits during transit.
The WFH Humanitarian Aid Program moves millions of IUs of factor and thousands of milligrams of non-factor replacement therapy every year—a testament to the strong partnerships fostered by the WFH over years, and to the rigorous standards that are adhered to every day. These efforts ensure that life-saving treatments reach people with bleeding disorders safely and efficiently, helping expand access to care around the world.
Find out more
This is the second article on the processes used by the WFH Humanitarian Aid Program to deliver product where it’s needed most. The first, “Mastering logistics to deliver humanitarian aid where it’s needed” covers the basics of shipping product.
To find out more about the WFH Humanitarian Aid Program, click here.
About the WFH Humanitarian Aid Program
The WFH Humanitarian Aid Program improves the lack of access to care and treatment by providing much-needed support for people with inherited bleeding disorders in developing countries. By providing patients with a more predictable and sustainable flow of humanitarian aid donations, the WFH Humanitarian Aid Program makes it possible for patients to receive consistent and reliable access to treatment and care. None of this would be possible without the generous support of Sanofi and Sobi, our Founding Visionary Contributors; Bayer, CSL Behring and Roche, our Visionary Contributors; Grifols, our Leadership Contributor; and Takeda, our Contributor. To learn more about the WFH Humanitarian Aid Program, visit www.treatmentforall.org.
