What is the toolkit?
Protecting the integrity of the medical product supply chain is complex and requires a global approach. FDA led a collaboration within Asia Pacific Economic Cooperation (APEC) economies to create a Supply Chain Security Toolkit for Medical Productsto maximize available global resources and to deliver quality trainings and best practices and for securing the global supply chain for medical products. The toolkit covers the entire supply chain and lifecycle of medical products from raw materials to use by patients. It focuses on developing — and implementing through training programs — processes, procedures, and tools directed at enhancing global medical product quality and supply chain security.
What is in the toolkit?
Comprehensive product quality and supply chain security requires a multi-layer approach that includes prevention, detection, and response strategies and actions. The toolkit is a comprehensive resource that addresses areas of vulnerability in the medical product supply chain and contains recommended best practices and tools to prevent and detect substandard and falsified medical products before they reach consumers. It also provides tools to efficiently and effectively respond to incidents involving substandard and falsified medical products.
The toolkit contains training materials intended to educate regulators, industry, health care professionals, and others on a particular part of the supply chain in 10 categories:
- good manufacturing practices;
- good distribution practices;
- good import/export practices;
- clinical/retail pharmacy practices;
- product security;
- detection technology;
- internet sales;
- track and trace systems;
- surveillance and monitoring; and
- single points of contact.
Why did FDA work on a supply chain toolkit?
As the medical products industry has become more globalized and specialized, countries must increasingly rely on the global marketplace to provide the medical products needed to keep consumers healthy and ensure that access to legitimate products is not disrupted. In an effort to address this issue, regulators, industry stakeholders, representatives from non-governmental organizations, international organizations, and academics from across the globe came together to create a roadmap to promote global medical product quality and supply chain security, which includes the toolkit.
How will it be used?
The toolkit will be used by industry stakeholders and regulators from around the globe to adopt best practices, for training purposes, and to strengthen laws and regulations to protect consumers from unsafe and substandard drug products. APEC Training Centers of Excellence for Regulatory Science (CoE) will be established to further training and use of the toolkit. More information about the CoEs is available within the toolkit.