The medicines supply chain is a complex global marketplace of manufacturers, suppliers, and distributors. Disruptions to this system can prevent medicines from reaching the people who need them.
USP works with regulators, industry leaders, and other scientific experts to develop quality standards and solutions to enable a more resilient medicines supply chain.
Building a resilient supply chain requires:
Predicting and preventing drug shortages
Currently, no single entity has a comprehensive view of the medicines supply chain. End-to-end data and insights can help decision-makers identify potential vulnerabilities, understand root causes, and take action to improve the resilience and reliability of the supply chain.
The USP Medicine Supply Map identifies four main drivers that make a drug vulnerable to shortage: low prices, geographic concentration, manufacturing complexity, and quality concerns. Understanding these drivers can help leaders take more effective action to help people access to the medicines they need.
A data-driven, vulnerability-informed approach can help inform stakeholder actions – including drug makers, purchasing entities such as hospitals and GPOs, and policymakers – to effectively build a more resilient medicines supply chain.
The vast majority of active pharmaceutical ingredients made for the U.S. market are made outside of the U.S. Decision-makers need end-to-end supply chain data to incentivize resilience.
Utilizing standards to foster quality
Supply chain disruptions can create, or stem from, quality issues, that put patients at risk of receiving substandard or falsified medicines. Standards and standards-based solutions can accelerate innovation, support manufacturing scalability, strengthen regulatory frameworks, and foster trust in the quality of medicines.
From the sourcing of raw materials to packaging, labeling, distribution, and point-of-care administration, standards help ensure quality across the pharmaceutical product lifecycle.
Standards and other solutions help stakeholders ensure quality throughout the product lifecycle and the supply chain.
The USP PPQT program equips manufacturers with validated testing methods, combatting misinformation about drug quality, encouraging adherence to life-saving therapies for patients, and preserving the reputation of generic medicines.
USP, with input from its Compounding Expert Committee, provided standards and monographs to help frontline workers address shortages of manufactured IV fluids related to Hurricane Helene.
Scaling efficient, innovative, and diversified manufacturing
A strong, geographically distributed manufacturing base enables a more secure medicines supply chain. USP supports efforts to boost domestic production, increase competition, and mitigate risk of disruptions and shortages.
These efforts include promoting geographic diversification of manufacturing for key drugs and their active ingredients and components, bolstering U.S. manufacturing capacity, and reducing the technical barriers to aid in wider adoption of advanced manufacturing technologies (AMT).
Secure upstream pharmaceutical supply chain risks with data and advanced technologies to increase access to quality medical products for patients.
Expanding manufacturing helps to limit losses, spread risk, and secure multiple sources for manufacturing and production.
The CMKC is a free digital knowledge management resource for capturing, organizing, and updating rapidly expanding knowledge about continuous manufacturing, as well as an online community network where experts can collaborate to close existing knowledge gaps.
