News about GMP/cGMP


FDA: Toolkit for Supply Chain Security of Medicinal Products

In collaboration with APEC (Asia Pacific Economic Cooperation), the US FDA has created a Supply Chain Security Toolkit for Medicinal Products. The intention behind this new tool is to maximize available global resources and to deliver quality trainings and best practices in order to secure the global supply chain. It covers the entire supply chain and lifecycle from raw materials to use by patients.

How shall this be achieved?

The focus of the toolkit is on developing and implementing processes, procedures and on enhancing global medical product quality and supply chain security by means of training programs. According to FDA, this takes into account 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 FDA says.

The toolkit should apply to regulators, industry, health care professionals, and others on a particular part of the supply chain. It covers the following 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.

To create the toolkit and the associated road map, regulators, industry stakeholders, representatives from non-governmental organizations, international organizations, and academics from across the globe came together. In addition, APEC Training Centers of Excellence for Regulatory Science (CoE) will be established to further training and use of the toolkit.


FDA: Drug Supply Chain Integrity
FDA: Roadmap to Supply Chain Security