“The whole is greater than the sum of its parts” – Aristotle
This timeless quote comes to mind when pondering USP’s enduring relevance and the priorities guiding our work. When different components are combined to create a whole, the result can have greater value, meaning or impact than the aggregate effect of the individual components. It emphasizes the importance of interactions and relationships between components, each with its own purpose, and how they all contribute to an even greater common outcome.
The USP Convention is comprised of a wide range of organizations from around the world that hail from every corner of the scientific and healthcare spectrum, including stakeholders that represent government agencies, healthcare practitioner organizations, academia, industry associations, and more. USP Convention Members bring forward their respective expertise to help identify both challenges and priorities for the immediate and long-term future, ensuring USP addresses the urgent, real-world issues that impact the supply of quality medicines.
Every five years, our Convention Members gather to reflect on our achievements, reassess our priorities, and revise our overarching strategy in the context of the evolving global landscape. As part of this process, the Convention adopts Resolutions that confirm USP’s commitments to facilitate the development, manufacturing, and distribution of quality medical products with the ultimate objective of ensuring patient safety and advancing the supply of quality medicines.
As we wrap up our 2020-2025 cycle and begin another with the adoption of new Resolutions, it’s important to reflect on how the contributions of our staff, our volunteer leadership, Convention Members and the hundreds of Expert Volunteers who serve on our standards-setting committees are essential in enabling USP to stay true to our centuries-old mission. While each Resolution and individual in this impressive network may focus on a unique challenge or opportunity, in aggregate, their impact on the supply of quality medicines exceeds the sum of the individual outcomes.
Reflecting on the 2020-2025 cycle
At the start of the 2020-2025 cycle, the USP Convention adopted 15 Resolutions to guide standards development, advocacy, and capability building – all to help ensure global access to quality-assured medicines, dietary supplements, and food ingredients.
The cycle presented many opportunities for USP to help safeguard the integrity of the pharmaceutical supply chain and increase the availability of quality medicines through standards and solutions and by leveraging new technologies and innovation.
Maintaining and evolving USP Standards for quality
USP Standards are foundational to the quality of so many of the medicines, dietary supplements, and food ingredients relied upon by people around the world. Over the past five years, we’ve enhanced and streamlined processes for developing and revising quality standards so we can respond to changes in the manufacturing and regulatory landscape and increase the efficiency with which manufacturers can bring products to market.
At the same time, we’re making progress in transforming quality standards into interoperable digital components of the healthcare ecosystem to continue to support our stakeholders in an increasingly interconnected world. Digitally integrating USP standards into their processes helps manufacturers, regulators, healthcare professionals, and other stakeholders deliver quality medicines by facilitating a more reliable medicines supply chain.
Advances in science and technology enable innovative therapeutics that bring with them new and different quality challenges. In the 2020-2025 cycle, USP expanded its portfolio of standards, best practices, and tools to support the quality, consistency, and availability of biologics and advanced therapies. With standardized and validated analytical methodologies, along with reference standards and materials, USP is helping to accelerate development and market entry of therapies, including monoclonal antibodies, cell and gene therapies, and more.
Keeping medicines – and patients – safe from impurities
To address the threat of medicines with unsafe levels of contaminants or impurities, USP evaluated and refined its standards and solutions to help manufacturers and regulators protect patients:
- Diethylene glycol (DEG) and ethylene glycol (EG) contaminants in cough medicines were linked to the deaths of children around the world. In response, USP published a toolkit offering relevant chapters, monographs, and additional resources to help manufacturers, regulators, and other pharmacopeias implement quality controls and risk assessments to address contamination and keep patients safe.
- When commonly used drugs ranging from antacids to blood pressure medications were recalled due to nitrosamine impurities, USP responded with analytical tests, standards, reference materials, and an online community, where members share information to collaboratively discuss and overcome nitrosamine challenges.
We also worked with regulators and other stakeholders globally to implement our standards as part of their strategies to control the risk of impurities and help prevent, detect, and eliminate substandard and contaminated medicines. Our broader work to advance adoption of quality standards, guidelines, and best practices has resulted in improving the quality of medicines, dietary supplements, and food ingredients for more than 2 billion people around the world.
Supply chain resilience
The globalization of the medicine supply chain has lowered costs and expanded access – but it has also increased vulnerabilities, especially due to the concentration of manufacturing in a few geographies, which amplifies the impact of acute disruptions. These issues came into glaring focus during this past cycle.
USP developed the Medicine Supply Map (MSM) intelligence tool to predict drug shortages and mitigate their impact. The MSM empowers stakeholders to take proactive measures before a crisis happens. Insights into the geographic concentration of pharmaceutical manufacturing, along with other factors that correlate with the risk of shortages, help stakeholders identify, characterize, and quantify vulnerabilities in the upstream supply chain to guide risk mitigation strategies and investments and inform policy changes to make the supply chain more reliable.
A stronger supply chain requires a comprehensive strategy that aligns stakeholders – public and private, U.S. and global, upstream to downstream – with each contributing information, resources, and expertise. In our next cycle, USP will continue to leverage its stakeholder network to provide data that informs decisions to make the supply chain stronger.
In addition to creating the MSM, USP employed a range of strategies to enhance the resilience of the global medicines supply chain. We collaborated with stakeholders to address potential challenges of pharmaceutical impurities and contaminants, promote good distribution practices, and increase supplies of quality vaccines and essential medicines. Our efforts spanned Latin America, Africa, and other regions, addressing supply chain vulnerabilities, supporting the implementation of quality standards, harmonizing and converging quality testing practices across borders, and advocating for investment in medicine quality.
Through our Promoting the Quality of Medicines Plus (PQM+) program, USP supported the advancement of 40+ national regulatory authorities in strengthening their regulatory functions and maturity levels, as defined by the World Health Organization Global Benchmarking Tool. Across multiple countries and regions, USP’s work to support regulatory efficiencies and capability building included advancement of cross-border regulatory harmonization and convergence initiatives. We are proud of our recent program announcement, Access for Africa, through which the USP-NF and USP Education training library will be available free of charge to all stakeholders in Africa working to advance the pharmaceutical ecosystem, including regulatory authorities, laboratories, academic institutions, and manufacturers.
Looking ahead with reaffirmed commitment
In an environment rich with opportunities to address health challenges, discussions at our upcoming USP Convention Meeting and the new Resolutions that will be adopted will guide us into the future. Some Resolutions will build on foundations established in the current or previous cycles, while others will address urgent or emerging challenges, such as fostering environmental sustainability throughout the pharmaceutical manufacturing process.
We will continue to work diligently to build frameworks that tackle quality assurance challenges in areas of scientific advancement, such as cell and gene therapy, 3-D printing, biopharmaceuticals, and other exciting areas that offer promise but require new approaches.
Fulfilling these commitments requires innovative thinking and bold plans. Thanks to expert input from our stakeholders, who represent every link of the medicines supply chain, and continuous engagement with USP Convention Member organizations, regulatory leaders, and others, we are positioned to address the challenges and priorities of our stakeholders as we develop practical, real-world solutions together.
While realizing the goals of each Resolution is meaningful on its own, together, their impact is amplified. Though each Resolution is distinct, they are tied together by a common thread woven throughout USP’s history: our commitment to help billions of people around the world trust the quality of their medicines, dietary supplements, and food ingredients.
