Implementing ICH Q9(R1) Will Entail a Heightened Focus on Integrating Knowledge into Risk-Based Decision-Making


Full implementation of the revisions that have been made to ICH’s Q9 guideline on quality risk management (QRM) will entail a heightened focus on how to best integrate knowledge into risk-based decision-making (RBDM) and is expected to be a mid-term rather than short-term project, according to the rapporteur and members of the guideline revision Expert Working Group (EWG).

The targeted Q9 revision reached Step 4 of the ICH process in January 2023, and training materials are expected to be released in the fall. Key issues addressed more substantively in the revision are:  ● subjectivity in QRM ● product availability risks ● formality in QRM ● risk-based decision-making ● risk review, and ● hazard identification.

A meeting in early June 2023, held at the Technological University Dublin (TU Dublin), brought together QRM experts from regulatory agencies, industry, and academia to discuss the revision focus areas. Organized by the TU Dublin-based Pharmaceutical Regulatory Science Team (PRST), participants explored how the effective use of knowledge can enhance quality risk management outcomes to benefit patients.

Since its inception in 2005, PRST in conjunction with Ireland’s Health Products Regulatory Authority (HPRA) and Regulatory Science Ireland (RSI) have been active participants in the research and dialogue around QRM, knowledge management (KM), operational excellence (OpEx), post-approval change management (PAC), quality metrics, and related topics covered by the ICH quality guidelines. The journey from ICH Q9 to ICH Q12 is described on the PRST website (see link below).

In 2015, PRST members participated in an influential symposium on KM in the pharmaceutical industry (see IPQ July 6, 2016), and a follow-up symposium was held in 2019 on the interplay between QRM and KM. Also contributing to the dialogue in Europe was a virtual “QRM Summit” emanating from Lisbon, Portugal in February 2021 (see IPQ April 29, 2021).

The IPQ story includes a discussion of ISPE’s engagement with the drug shortage component of the QRM equation that took place at the ISPE Singapore meeting in August. 

● Part I: Insights from Expert Working Group Members on ICH Q9 Revisions

The story begins with a review of the morning plenary session at the PRST meeting – focusing in particular on the presentation by Ireland HPRA’s Kevin O’Donnell, who has been serving as rapporteur on the ICH Q9(R1) Expert Working Group (EWG). O’Donnell outlined the main changes introduced in the revision, including amendments made in response to the public consultation. He then addressed the practicalities of implementation, including his “personal thoughts” on the implementation process.

● Part II: Panel Discussion Among PRST Meeting KM/QRM Experts

Part II focuses on a panel discussion that concluded the PRST meeting morning session, in which O’Donnell and the other speakers participated – including former NASA KM/QRM expert Ed Hoffman, Boehringer Ingelheim’s Emma Ramnarine, former FDA KM/QRM expert Gregg Claycamp, and Kronos Bio’s Anders Vinther – along with HPRA’s Grainne Power. Focal points during the discussion were: ● the role of senior management in GMP ● practical implementation of formality in QRM ● the definition of a “subject matter expert” ● thinking from a systems perspective ● QA’s role in innovation, business continuity, and decision-making ● return on investment with application of QRM, and ● creating an open culture for risk management.

● Part III: Application of Risk-Based Decision-Making

Part III provides two perspectives on the application of risk-based decision-making shared later in the meeting. Novo Nordisk’s Michael Schousboe, who has been representing EFPIA on the Q9(R1) EWG, discussed: ● the Q9 revision, ● examples of RBDM using knowledge from other QRM activities, and ● learnings from setting up decision processes. PRST member Valerie Mulholland, who is in the final stages of a PhD at TU Dublin, addressed: ● risk management communication tools across history ● human factors and decision complexity, and ● insights gained through her research on the role of knowledge in improving RBDM.

● Part IV: Risk Management in Drug Shortage Prevention

The final part of the story homes in on another one of the topics addressed in the Q9 revision – product availability risks and the relationship of manufacturing/quality problems to drug shortages. Recent FDA and EMA guidances on drug shortages are reviewed, along with industry insights on the complexity of the issues involved and the need for  systems thinking and global regulatory convergence offered by BI’s Ramnarine at the PRST meeting and by Merck’s Diane Hustead at the ISPE Singapore conference.

LINK: ● PRST website

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