The New ICH Q9 Guideline: The Next Generation of Quality Management

A report from the PDA/FDA Joint Regulatory Conference 2023

7 min. reading time | by Thomas Peither
Published in LOGFILE 37/2023

Subjectivity in QRM should be addressed in every organisation. I had the opportunity to attend a very stimulating presentation by Alex Viehmann, Division Director at OPQ, CDER, U.S. FDA, who shared insights into the new ICH Q9 Guideline on Quality Risk Management (QRM) at the PDA/FDA Joint Regulatory Conference 2023, 18-20 September in Washington.

One key topic that caught my attention was "Subjectivity in QRM".

The problem with subjectivity:

Subjectivity in risk assessment and QRM processes can be problematic for several reasons. It deviates from the fundamental QRM principle of basing risk development on scientific evidence, which is ultimately linked to patient protection. Subjectivity can manifest itself in different ways, ranging from different stakeholder perceptions of hazards, risks and harms, to biases, assumptions and the use of risk scoring methods. This subjectivity can lead to biased risk assessments, suboptimal risk controls, poor risk-based decisions and ineffective QRM outcomes.

The risks of subjectivity:

• Hazards may be inadequately identified, resulting in unmanaged risks.
• Probabilities of occurrence and severity of harm may be inaccurately estimated in risk assessments.
• Subjective assumptions about the value and effectiveness of risk controls can lead to overestimation of risk reduction, creating a false sense of security.

The benefits of controlling subjectivity:

Efforts to minimise subjectivity in QRM yield significant benefits:

• Fewer quality defects, improved patient safety.
• Science-based manufacturing processes, control strategies and validation activities.
• Potential cost reductions and reallocation of resources to critical activities.
• Accelerated implementation of key guidelines such as Q8, Q10, Q11 and Q12 due to the fundamental importance of QRM.

Let's embrace objective QRM!

In an industry where patient safety and product quality are paramount, addressing subjectivity in QRM is critical. We must collectively acknowledge, anticipate and control subjectivity through bias mitigation, informed tool use and data maximisation. Resource constraints should never compromise the rigour of the QRM process.

Alex Viehmann's insights remind us that objective, science-based risk assessments enable us to create safer products, optimise operations and accelerate the implementation of critical quality policies. Let's embark on this journey towards more robust and effective quality risk management!

Lifecycle Management of Risks to Ensure an Ongoing State of Control

Denise DiGiulio, Head of Global Audit and Inspection Management at Genentech, shared some valuable perspectives on implementing the ICH Q9 Guideline for Quality Risk Management. Here's some insight from her enlightening presentation at the PDA/FDA Joint Regulatory Conference 2023:

Quality Risk Management (QRM) is about staying ahead of the curve by "taking into account new knowledge and experience”. In our ever-evolving pharmaceutical landscape, adaptability is key!

Lifecycle events can have a significant impact on our initial quality risk management decisions. Flexibility and a proactive approach are essential.

An effective pharmaceutical quality system isn't just about compliance; it's a driving force behind supply chain robustness and sustainable GMP compliance.

It also acts as an early warning system, leveraging quality risk management and knowledge management. This dynamic duo helps us stay vigilant and respond effectively to evolving quality and manufacturing risks, whether they come from within our organisation or from external partners.

Denise's insights underscore the importance of continuous learning and adaptation in the pharmaceutical industry. Let's embrace these principles to ensure the safety and quality of our products. Thank you, Denise, and thank you to the PDA for bringing these issues to the stage.

Do you have any questions or suggestions? Please contact us at: redaktion@gmp-verlag.de