The Role of Standards in the Drug Supply Chain

In June 2026, the US Pharmacopeia (USP) published its annual drug shortages report, which stated that while drug shortages are lasting longer, the total number of shortages decreased by 23% in 2025.1,2 USP also found that product discontinuation was higher, with a 60% increase from 2024 to 2025.

Drug shortages can result from a variety of factors including quality problems, manufacturing complexity, natural disasters, geopolitical pressures, and policy changes. PharmTech spoke with Gabriela Grasa Mannino, senior director, Advanced Supply Chain Solutions at USP to find out about the variables impacting the supply chain and how USP is doing its part to ensure the supply is secure.

PharmTech: How has the supply chain risk landscape in pharmaceutical manufacturing fundamentally changed in the past 5 years? What risks are still underestimated today?

Gabriela Grasa Mannino (USP): Today, we are seeing the consequences of a supply chain that has become increasingly fragile over time. In the United States, for example, we have seen a persistence of drug shortages, which now last an average of 5 years, up from 2 years in 2019 according to USP’s recent analysis. However, shortages are not the root cause of supply chain fragility, but the most visible symptom of deeper issues in manufacturing systems.

These shortages reflect underlying vulnerabilities, including limited redundancy, geographic concentration, quality variability, and broader structural weaknesses in supply chain design.

The nature of supply chain risks has also changed, as they are no longer exclusively episodic. We have moved from disruptions driven by isolated events to a more persistent, systemic level vulnerabilities.

Today, manufacturers operate in a more dynamic and less predictable environment, where disruptions are harder to anticipate and increasingly complex to manage.

Looking ahead, these challenges are likely to persist, especially for products that rely on concentrated or highly specialized production. This really reinforces the need to address the underlying system, not just react to the outcomes.

USP has studied supply chain risk drivers. What are the most critical vulnerability factors today, and how should manufacturers be thinking about them differently?

USP has identified 4 key drivers of supply chain vulnerability: geographic concentration, manufacturing complexity, low prices, and quality concerns. These factors are closely linked to how manufacturing systems are designed and operate.

When production is concentrated to a few locations or manufacturing processes are highly complex, flexibility is limited and disruptions can escalate quickly. Similarly, recurring quality issues can signal broader structural weaknesses that increase risk across the medicine supply.

As a result, some manufacturers are shifting their focus to building more resilient manufacturing systems and processes. Specifically, many organizations are now taking a more data-driven and proactive approach to identify vulnerabilities across their portfolios, strengthening process controls, increasing flexibility, and diversifying production. It’s increasingly critical for manufacturers to prioritize and invest in robust, consistent, and diversified manufacturing operations to enable future supply chain resilience.

Quality and standards are sometimes perceived as constraints. How do USP standards actually enable resilience, speed, and supply reliability?

Quality is a core factor in determining whether a system performs reliably under pressure. Many supply chain disruptions originate upstream from variability in quality or in process performance. Quality standards are critical to enabling consistent, reliable systems and processes across manufacturers.

Standards play an important role in pharmaceutical manufacturing because they create a common scientific and quality framework. They help reduce variability and align expectations across sites, partners, and processes. In practice, this means smoother operations, including more predictable outcomes, fewer disruptions, and more efficient technology transfer. There are also benefits from a regulatory perspective, such as improved alignment and, in some cases, streamlined reviews, especially for generic medicines.

How are organizations redesigning their supply chains beyond reshoring to build greater resilience across manufacturing and supplier networks, and where are companies still getting this wrong?

Rather than applying a one-size-fits-all strategy, organizations are assessing risk at the product and portfolio level and tailoring their manufacturing systems accordingly. This may involve increasing regional production capacity for critical medicines, building redundancy, and investing in more flexible manufacturing processes that can adapt to changing demand or disruptions. A key component of this approach relies on process and quality consistency to ensure that manufacturing can be transferred or scaled when needed.

Companies can also strengthen resilience within existing supplier networks by treating suppliers as more strategic, integrated partners. This starts with stronger collaboration and alignment around quality and manufacturing performance. Improved transparency across the network helps companies identify vulnerabilities earlier and respond quickly to disruptions.

At the same time, it’s critical to look beyond Tier 1 suppliers. Many supply risks originate further upstream, particularly for key starting materials and APIs. By better understanding these dependencies, organizations can identify concentration risks and potential points of failure before they impact production.

Resilience efforts should not focus on a single solution, such as reshoring. While this can reduce risk, it does not automatically improve resilience if underlying process controls, quality systems, or supplier networks remain vulnerable.

The organizations making the greatest progress are implementing a system-wide approach, which enables greater flexibility. Improved resilience at the network level comes from a combination of strong partnerships, shared frameworks, and better data visibility.

What does an adaptive or resilient production system look like in practice?

In simple terms, an adaptive or resilient production system can respond to changes, such as unexpected disruptions or supply constraints, while maintaining quality and regulatory compliance.

The foundations of these systems are built on robust, well-characterized manufacturing processes. When these processes are stable and consistent, it becomes easier for manufacturers to scale, transfer, or adjust production. Many organizations are also integrating greater flexibility into operations through continuous manufacturing or modular approaches. These approaches may help reduce dependencies on a single facility and allow for more responsive operations when conditions or needs change.

Digital capabilities also play a key role in enhanced process monitoring, real-time data sharing, and access to advanced analytics, providing greater visibility into manufacturing performance and enabling earlier, informed decision-making.

Resilient production systems are not defined by a single technology or manufacturing model; they require alignment between processes, quality systems, manufacturing capabilities, and available data.

Where are artificial intelligence (AI) and predictive tools delivering value and where is there untapped opportunities for industry?

AI and predictive technologies are already delivering value across pharmaceutical manufacturing in areas including predictive maintenance, process optimization, and real-time quality monitoring. These tools can help identify risks earlier, improve process stability, and allow earlier interventions, which prevent issues from escalating.

Industry is also beginning to use AI to strengthen decision-making by providing greater visibility into manufacturing operations and enabling more proactive responses to emerging risk.

That said, there is still opportunity to extend these capabilities across the broader supply network. Although many organizations have successfully implemented predictive tools to some degree, fewer organizations have achieved end-to-end predictive risk management across the full supply network.

However, it’s important to note that the technology itself does not deliver the full value; real impact is realized when these tools are embedded within strong manufacturing systems, with the right processes and governance in place. In that environment, AI becomes more of an accelerator, enhancing visibility and responsiveness.

What are the biggest internal barriers to adopting these technologies?

Barriers to adopting AI and predictive technologies in pharmaceutical manufacturing can be organizational, cultural, or operational, rather than technical. For example, if manufacturing processes are not standardized or data are poorly structured, it can be difficult to fully leverage digital tools.

In a highly regulated environment, there can also be a natural hesitation to move away from established ways of working, especially when it could bring regulatory uncertainty. However, regulators have been increasingly supportive of the adoption of innovative technologies.

Over time, we’ve seen a phased approach starting with targeted applications that demonstrate clear value work well for many organizations. Early applications can help build confidence, create momentum, and show how digital tools can strengthen existing systems. Equally important is alignment across various functions such as quality, operations, digital, and regulatory. With cross-functional alignment, companies are better positioned to accelerate the implementation of these technologies while ensuring adoption supports compliance and improves performance.

How is USP evolving its standards and reference materials to support advanced manufacturing technologies such as continuous manufacturing and complex modalities?

USP is actively evolving its standards to reflect the increasing adoption of advanced manufacturing approaches, including continuous manufacturing and more data-driven quality systems. This includes developing and updating general chapters, analytical methods, and reference materials that support these emerging technologies while maintaining a strong scientific and quality foundation.

A key focus is ensuring that standards are rigorous, adaptable, and able to support different manufacturing approaches while providing clear expectations for quality and performance. This flexibility is particularly important as manufacturers introduce new technologies and production models that may not fit within traditional frameworks.

We also place strong emphasis on collaboration with industry and regulators, which helps ensure that standards remain relevant, practical, and aligned with evolving regulatory expectations. This alignment can support more predictable implementation and broader adoption of innovative approaches.

In this way, standards help bridge the gap between individual innovation efforts and system-wide reliability, enabling advanced manufacturing to scale in a way that consistently supports quality and supply continuity.

As biologics and complex therapies evolve, how must standards and reference materials adapt to ensure quality and supply continuity?

As biologics and other complex therapies continue to evolve, standards and reference materials must keep pace with fit-for-purpose analytical approaches. As products have grown increasingly complex, traditional approaches cannot always be applied in the same way.

Well-characterized reference materials and advanced analytical tools remain essential for the consistent measurement of quality attributes, supporting product comparability, performance, and patient safety. A hybrid standards model that combines platform and cross-cutting standards with product-specific standards can provide both scientific rigor and increased flexibility, helping manufacturers make informed decisions, strengthen process control, align with regulatory expectations, establish robust control strategies, and support the reliable supply of these therapies.

More broadly, how does USP contribute to strengthening supply chain security and preventing drug shortages at a system level?

USP strengthens supply chain security through standards and insights. To this end, USP brings a unique perspective through data and insights on supply chain vulnerabilities, helping stakeholders better understand where risks exist and how they may evolve. This supports a more proactive approach to managing potential disruptions, rather than reacting once they occur.

We also work to support capacity-building efforts and cross-sector collaboration, including public-private partnerships aimed at strengthening manufacturing capabilities and supply chain robustness, particularly for critical medicines.

At a system level, USP’s role is to help ensure that the pharmaceutical supply chain is not only efficient but also designed to be resilient by being grounded in science, aligned quality systems, and a shared commitment to reliability and patient access.

Looking ahead 3 to 5 years, what will differentiate pharmaceutical manufacturers that turn resilience into a competitive advantage, and what should leaders prioritize today to get there?

Over the next 3 to 5 years, the pharmaceutical manufacturers that stand out will be those that view resilience as a business priority, creating systems and operations that can adapt quickly while consistently delivering safe, quality medicines.

One important step leaders can take today is to build end-to-end visibility and predictive capabilities across their manufacturing and supply networks. The ability to anticipate risks, access and analyze data to drive decision-making, and proactively identify and reduce disruptions before they occur is becoming a key differentiator.

Achieving this requires more than new technology. It depends on integrating data across functions, strengthening analytics, and aligning decision-making throughout the organization. Ultimately, resilience becomes a competitive advantage when manufacturers build systems that are visible, predictable, and adaptable.

References

1. USP Annual Drug Shortages Report finds rising discontinuations, hidden upstream risk. Press release. USP. June 9, 2026. https://www.usp.org/news/usp-2026-annual-drug-shortages-report-rising-discontinuations-supply-chain-risk
2. USP. 2025 USP Annual Drug Shortages Report. US Pharmacopeia. June 2026.

About the Speaker

Gabriela Grasa Mannino works at the United States Pharmacopeia (USP) as the Senior Director of Advanced Supply Chain Solutions, where she leads strategic initiatives focused on pharmaceutical market intelligence, supply chain resilience, and advanced manufacturing.

Her work sits at the intersection of science, business, and policy. At its core, it’s about advancing medical supply security while enabling scalable, sustainable manufacturing, particularly to support domestic production. In practice, that means working closely with industry, academia, government, and other stakeholders to strengthen supply chain resilience, whether through standards, insights into vulnerabilities, or collaborative programs that help build more robust manufacturing ecosystems.