Elevating Pharmaceutical Quality: Insights from the FDA’s Office of Quality Surveillance and ISPE’s APQ Program

The OQS, situated within US FDA CDER's Office of Pharmaceutical Quality (OPQ), plays a vital role in ensuring pharmaceutical quality through comprehensive surveillance throughout the medicinal product lifecycle. The office has developed a comprehensive framework encompassing five core functions that ensure medicinal product safety and reliability throughout the medicinal product lifecycle:

• Supply Chain Insight: OQS maintains comprehensive supply chain oversight through US FDA's CDER site and product catalogs, supplemented by drug amount reports mandated by the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act
• Advanced Analytics: Employs current modeling science and risk-based site selection model to prioritize inspections and identify anomalies in manufacturing processes
• Assessment: Investigates quality signals through targeted evaluations to identify and address potential manufacturing issues
• Response Action: Deploys surveillance tools like US FDA Adverse Event Reporting System II (FAERS II) to mitigate manufacturing risks when issues are detected
• Innovation: Develops forward-looking solutions for quality surveillance like integration of the Federal Emergency Management Agency’s (FEMA) National Risk Index to anticipate and minimize supply chain disruptions from natural disasters

One of the most visible of US FDA's quality initiatives is the Quality Management Maturity (QMM) program—part of OQS’s assessment function. At its core, the program aims to foster a strong quality culture while recognizing and encouraging manufacturers who implement advanced quality management practices beyond basic compliance requirements.

Emerging from a 2019 drug shortage report, the QMM program addresses the market's failure to reward mature quality management systems through a comprehensive rating system. The program evaluates manufacturers across five critical areas: management commitment to quality, business continuity, advanced pharmaceutical quality systems, technical excellence, and employee engagement and empowerment (see the 2023 white paper). Through these assessments, the US FDA identifies enhancement opportunities and provides targeted growth recommendations, ultimately working to strengthen supply chain reliability and product availability.

The program's prototype assessment protocol evaluation began in early 2024, with nine volunteer manufacturers participating in the prototype assessment protocol. Six assessments were completed by the ISPE Annual Meeting & Expo in October 2024, with plans for additional volunteer cohort in 2025.

The QMM program's focus on continuous improvement and product availability aligns with ISPE's APQ program, which provides industry with practical tools for enhancing quality systems based on the ICH Q10 model. The APQ program offers a structured framework that guides manufacturers through a four-phase journey:

1. Assess current quality management maturity using a five-step rubric
2. Aspire to improvement goals
3. Act on developed action plans
4. Advance through evaluation of improvement outcomes

The program provides comprehensive assessment tools, standardized performance indicators for benchmarking, and practical strategies for implementing sustainable quality improvements, including a library of improvement activities.

The complementary nature of these initiatives reveals a shared vision for pharmaceutical quality advancement. Both programs emphasize the integration of quality practices at all operational levels, promoting a shift from reactive to proactive quality management. They also recognize the crucial role of data-driven decision-making. While the APQ program enables manufacturers to quantitatively and qualitatively evaluate their quality systems and target improvements, OQS leverages analytics to identify and address quality risks that could impact drug availability.

This alignment between regulatory and industry efforts is crucial for ensuring pharmaceutical quality. By working toward a shared goal, the US FDA and ISPE are creating a more resilient pharmaceutical ecosystem—one that reduces manufacturing quality defects, strengthens supply chain resilience, and fosters a culture of excellence. While the US FDA provides essential oversight and guidance, industry stakeholders must take responsibility for implementing robust quality systems that protect public health.

Looking ahead, the journey to elevated pharmaceutical quality requires ongoing commitment from both regulators and industry. The US FDA’s Office of Quality Surveillance and ISPE's APQ program are leading the way by providing innovative solutions and practical tools to achieve this shared mission in their respective roles. By embracing sustainable and mature quality management systems, manufacturers can build more reliable supply chains and ensure every dose of medicine fulfills its fundamental promise to patients.

We invite manufacturers to take the next step in their quality journey by exploring the APQ program and aligning their practices with evolving US FDA expectations. An excellent opportunity to advance an organization’s quality management maturity is the through the ISPE APQ Quality Management Maturity Training Course. This comprehensive course equips participants with best practices for conducting an assessment, practical tools to evaluate quality system effectiveness, and the confidence and expertise needed to drive continuous improvement.

Ready to elevate your pharmaceutical quality? Visit ISPE’s APQ page and explore the US FDA’s resources on QMM. Together, we can elevate pharmaceutical quality to new heights.