Drug shortages have risen markedly over the past 20 years, reaching unprecedented levels. Large-scale disruptive events, such as natural disasters, cyberattacks, the COVID-19 pandemic, and geopolitical constraints, have further exposed vulnerabilities in global supply chains.
While these acute events can trigger significant shortages, more persistent challenges to supply continuity remain, including quality and manufacturing issues as well as non-compliance with Good Manufacturing Practices (GMP). The recognition of these growing and systemic challenges has led to the 2023 update of ICH Q9, reinforcing the role of quality risk management (QRM) in supporting supply continuity and ensuring product availability for patients.
The revision provides greater clarity on formality, subjectivity, product availability, and risk-based decision-making, while also reinforcing the critical role of knowledge management and senior leadership engagement.
New ISPE Guide Elevates QRM
ISPE has now released a new Guide on moving beyond a tool‑centric or compliance‑driven view of QRM toward a mature, value‑driven approach that is embedded within the pharmaceutical quality system.
The ISPE Guide: Quality Risk Management translates the principles and expectations of ICH Q9(R1) into practical, actionable guidance for applying QRM. It emphasizes that QRM is not a one‑time exercise and does not consist solely of a risk assessment. It is a closed‑loop, iterative process that applies knowledge, informs decisions and continually adapts to incorporate new insights.
Practical Advice
“What we wanted to do was to take the Guideline ICH Q9(R1) and distill it into a handbook for the industry,” said Alice Redmond, ISPE QRM Guide Lead. The Guide is designed to help organizations:
- Apply the principles of ICH Q9(R1) consistently and effectively across development, technology transfer, commercial manufacturing and post-approval
- Reduce subjectivity in risk assessments by leveraging structured approaches, appropriate tools, facilitators, evidence and knowledge management
- Determine and apply the right level of formality, proportionate to risk, uncertainty and complexity
- Strengthen risk-based decision-making at both operational and leadership levels
- Integrate QRM with the pharmaceutical quality system to support a state of control and continual improvement
- Address product availability and supply resiliency risks
“QRM is like an umbrella over a number of steps that need to happen. This is a very practical handbook as to what is important, what the regulatory foundations are, where the industry has been making mistakes and where to start.”
Understanding Risk
Redmond also emphasizes that risk is not solely the responsibility of the quality team. “They’re usually the ones left holding the baton, but the risk culture and understanding goes right across the organization.”
Companies can only truly understand risk when they identify and understand the hazards associated with what they are doing. “Whether it’s an analytical method, formulating a buffer, producing the drug, packaging the drug or labeling the drug, we need to state the hazards every time,” says Redmond.
By addressing long‑standing challenges in QRM implementation and providing concrete examples, decision frameworks and case studies, the guide should help organizations strengthen their pharmaceutical quality system, improve supply resiliency and deliver safe, high‑quality medicines.
Regulatory Readiness
“A few hundred global regulators have already been trained on the updated ICH Q9 guidance,” says Redmond, underscoring the need for companies to prepare. She notes, “The ISPE guide covers the full product lifecycle, integrating regulatory expectations, ISO standards, knowledge management principles and operational excellence practices.”
All quality issues have the potential to affect product availability. With this potential for interconnected issues, a holistic, global, enterprise-wide approach to risk management and alignment on supply resiliency strategies is key to achieving optimal product availability.
Organizations need proactive risk management that shifts from an obligatory task to something that is ingrained, habitual and part of the quality culture.