FDA launches Supply Chain Security Toolkit for Medical Products

The U.S Food and Drugs Administration (FDA) has led a collaboration to create a Supply Chain Security Toolkit for Medical Products to maximise the available global resources and to deliver quality training and best practices for medical products.

The FDA has collaborated within Asia Pacific Economic Cooperation (APEC) economies, to produce a toolkit which covers the entire supply chain and life-cycle of medical products from raw materials to use by patients. The collaboration focuses on developing — and implementing through training programs — processes, procedures, and tools directed at enhancing global medical product quality and supply chain security.

As the medical products industry has become more globalised and specialised, 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 organisations, international organisations, and academics from across the globe have come together to create a road-map to promote global medical product quality and supply chain security, which includes the toolkit.

What is in the toolkit?

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 training materials inside the toolkit contains material 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
• Single points of contact.

The aim of this project is that 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.