USP collects Data for global Medicine Supply Map

Recommendation

15-17 May 2024
Berlin, Germany

The GMP-Auditor
Initial and Continuous Professional Training for GMP Auditors

The U.S. Pharmacopeia (USP) maintains what it calls a global Medicine Supply Map, which draws on insights gained from applying USP quality standards at more than 22,000 sites worldwide, covering 92 percent of generic medicines approved in the United States. This includes the full range of medicines such as widely used drugs like antibiotics and statins to those that are urgently needed in small populations, such as paediatric oncology drugs. Here, derived "Medicine Supply Vulnerability Insights" provide a good insight into the vulnerabilities of the pharmaceutical supply chain.

This comprehensive USP overview leads to insights that can help take appropriate action to identify overly large API manufacturers, reduce disruptions and generate information to increase supply resilience. For example, the first results of the USP Medicine Supply Map Vulnerability Insights Series show the importance of large Indian facilities for active pharmaceutical ingredient (API) manufacturing. According to USP, more than 70% of API manufacturers supplying the US market are located overseas, and more than 60% of drug shortages are due to manufacturing quality issues.

The goal of all this is an innovative early warning system that helps identifying ingredients and finished products at risk of shortages so that suppliers, manufacturers and governments can take appropriate action.

Upcoming sessions at the USP Congress will use this as a basis to identify specific solutions to increase supply chain resilience and also to strengthen international cooperation between supply chain partners such as governments and manufacturers.