ICH Q9(R1) Training Group Work Plan 2025
A clear analysis of the Training Group milestones, revised QRM presentations, priority topics, and planned editorial review described in the 22 July 2025 work plan.
What is the ICH Q9(R1) Training Group Work Plan?
The ICH Q9(R1) Training Group Work Plan dated 22 July 2025 describes how the Training Group would complete updates to older ICH Q9 Briefing Pack presentations and review selected new Q8/Q9/Q10/Q11 lessons. The work continues the revision effort of the ICH Q9(R1) Implementation Working Group and focuses on bringing quality risk management training into line with the revised ICH Q9(R1) guideline.
Introduction
Why the ICH Q9(R1) Training Group Work Plan matters
Quality Risk Management training is only useful when its terminology, examples, decision tools, and case studies reflect the guideline people are expected to apply. The ICH Q9(R1) Training Group Work Plan, dated 22 July 2025, records a structured effort to update older learning material that was developed before the 2023 revision of ICH Q9.
The work plan explains that an Implementation Working Group operated from September 2023 to July 2024. A Training Group was then established in June 2024 at Fukuoka, Japan, to complete the remaining work. Its scope included updating 24 presentations in the ICH Q9 Briefing Pack from 2006 and reviewing selected draft lessons created for new ICH Q8/Q9/Q10/Q11 training.
This is more than a document-control exercise. For pharmaceutical companies, updated training can improve how teams identify hazards, select QRM tools, describe uncertainty, evaluate control options, and make decisions that protect product quality and availability. The plan also shows how a large technical training package can be prioritized, reviewed, edited, and routed through an official publication process.
Work plan identity
Who and what the 2025 work plan covers
| Work-plan element | Information recorded in the PDF | Why it matters |
|---|---|---|
| Topic adoption | June 2024 | Marks the establishment of the Training Group following the Fukuoka meeting. |
| Rapporteur | Dr. Kevin O'Donnell, European Commission, Europe | Identifies the person responsible for coordinating the work-plan topic. |
| Regulatory chair | Dr. Alex Viehmann, FDA, United States | Records regulatory leadership for the group. |
| Last face-to-face meeting | Fukuoka, Japan, June 2024 | Provides the meeting context for the Training Group's formation. |
| Document date | 22 July 2025 | Defines the status and timeline snapshot analyzed in this article. |
From IWG to Training Group
How the ICH Q9(R1) training update developed
The work plan states that the Training Group was created to complete work begun by the ICH Q9(R1) Implementation Working Group. The IWG had operated from September 2023 to July 2024 after the revision of the ICH Q9 guideline reached Step 4 in January 2023.
ICH Q9(R1) revision
The revised guideline introduced clearer expectations on subjectivity, product availability risks, formality, risk-based decision-making, hazard identification, and risk review.
Implementation Working Group
The IWG reviewed how older training materials should be corrected and aligned with the revised guideline and newer educational content.
Training Group formation
In June 2024, a Training Group was established to finish updates to the remaining Briefing Pack presentations and review selected draft lessons.
Prioritized completion
The group ranked the most important presentations, completed priority revisions, and sent revised material to the ICH Secretariat for editorial review.
Scope of work
What the Training Group was expected to update
The work plan relates to completing updates to 24 presentations in the ICH Q9 Briefing Pack from 2006. These presentations included material on QRM methods and tools, as well as potential applications across pharmaceutical activities.
Nine presentations
Nine presentations relate to QRM methods and tools referenced in Annex I of ICH Q9(R1). They help learners select and apply techniques such as structured analysis, statistical support, and hazard evaluation.
Nine presentations
Nine presentations relate to potential QRM applications referenced in Annex II, including development, production, facilities, laboratory control, packaging, and supply-chain activities.
Selected Q8/Q9/Q10/Q11 drafts
The group also reviewed five draft lessons - lessons 3, 5, 6, 7, and 8 - from a QRM and ICH Q9(R1) perspective.
Secretariat review
Revised presentations were sent to the ICH Secretariat for editorial review before planned publication on the ICH website.
Completed milestones
Key milestones recorded through July 2025
| Date | Milestone | Practical significance |
|---|---|---|
| July 2024 | Finalization of an introductory QRM and ICH Q9(R1) presentation for the Briefing Pack. | The new presentation replaced six unofficial presentations that had been in the Briefing Pack since 2006, while incorporating selected useful elements. |
| July 2024 | Finalization of a new ICH Q8(R2), ICH Q9(R1), and ICH Q10 presentation. | The new presentation replaced unofficial Q8/Q9/Q10 presentations hosted since 2010 and updated the integrated quality-development message. |
| July 2024 | Generation of revision 5 of the Q8/Q9/Q10 Questions and Answers document. | The revision updated the earlier revision 4 document following the ICH Q9 revision and was routed through the Minor Revision Procedure. |
| October 2024 | Approval of Q&A revision R5. | The work plan records that the updated Q&A version was approved on 30 October 2024. |
| September 2024 | Agreement of a plan and work schedule for the remaining 18 presentations. | Co-leads were assigned and the large update task was divided into manageable workstreams. |
| January 2025 | Priority listing of seven presentations. | The seven most important presentations were selected for earlier completion than the remaining 11. |
| February 2025 | Completion of reviews of five draft lessons. | Lessons 3, 5, 6, 7, and 8 were reviewed for QRM and ICH Q9(R1) alignment. |
| July 2025 | Revision of the seven prioritized Briefing Pack presentations completed. | The revised presentations were sent to the ICH Secretariat for editorial review while work continued on the remaining 11. |
Prioritization logic
Why seven presentations were prioritized first
The work plan records that the Training Group agreed a priority listing in January 2025. Seven presentations were selected as the most important, allowing the group to complete those updates before finalizing the remaining 11. The PDF does not list the seven completed presentation titles in the milestone table, but it clearly explains the management logic: address the most important training gaps first, then continue the broader revision.
For a pharmaceutical site, the same principle can be applied when prioritizing SOP revisions, data-integrity training, qualification procedures, or quality-system updates. Prioritization should be documented and connected to risk, content gaps, user impact, and regulatory relevance.
Future milestones in the document
Five presentations planned for September 2025
The work plan expected the next five outstanding presentations to be completed by September 2025 and then sent to the ICH Secretariat for editorial review. The topics were selected because they addressed content gaps and needed alignment with ICH Q9(R1).
Hazard Operability Analysis
Structured examination of deviations from intended process conditions and their potential consequences.
Supporting statistical tools
Use of statistical knowledge to improve evidence, variation analysis, and confidence in QRM conclusions.
Regulatory operations
Application of QRM thinking to regulatory activities and decisions.
Materials management
Assessment of material-related hazards, controls, suppliers, specifications, and lifecycle risks.
Supply chain control
Use of QRM to understand supply-chain vulnerabilities, continuity, and control strategies.
Remaining content
Six presentations planned for December 2025
The work plan then scheduled the final six presentations for completion by December 2025, followed by editorial review and planned publication. Their subject matter covers a broad set of pharmaceutical lifecycle applications.
| Presentation topic | Potential training focus |
|---|---|
| Combination of QRM tools | How multiple methods can be combined without creating unexplained complexity or double-counting risk. |
| Facilities, equipment, and utilities | Risk-based design, qualification, maintenance, monitoring, and change decisions. |
| Development | Use of QRM in pharmaceutical development, control strategy, and knowledge generation. |
| Production | Manufacturing process hazards, controls, deviations, trends, and continual improvement. |
| Laboratory control and stability studies | Analytical data, method performance, stability risks, sampling, and laboratory decisions. |
| Packaging and labelling | Mix-up, artwork, component, serialization, line-clearance, and communication risks. |
Integrated training
Review of lessons 3, 5, 6, 7, and 8
The Training Group also completed reviews of five draft presentations developed by a Training Associate for new ICH Q8/Q9/Q10/Q11 training. The work plan records that lessons 1, 2, and 4 had already been reviewed in 2023 and 2024. Lessons 3, 5, 6, 7, and 8 were reviewed by February 2025 from a QRM and ICH Q9(R1) perspective.
This integrated review is important because QRM should not sit apart from pharmaceutical development, quality systems, manufacturing knowledge, and API management. Decisions about process understanding, control strategy, equipment, materials, and lifecycle change can all benefit from consistent QRM principles.
Practical implementation
How pharmaceutical companies can use this work plan
Compare local material with ICH Q9(R1)
Check old slides, decision trees, forms, and case studies for outdated terminology, binary formality language, incomplete product-availability treatment, or unsupported risk scoring.
Improve the decision trail
Ensure risk records identify evidence, assumptions, uncertainty, controls, residual risk, approvers, and review triggers.
Protect QRM evidence
Apply ALCOA+ principles so risk assessments, approvals, calculations, and evidence remain attributable, complete, consistent, enduring, and available.
Embed risk in the QMS
Connect QRM to cGMP, change control, deviations, investigations, management review, and continual improvement.
Escalate systemic gaps
Use the approved CAPA process where outdated training or weak risk decisions reveal a recurring or systemic quality problem.
What the work produces
Key deliverables and editorial controls
The plan separates technical revision from editorial publication. This helps preserve scientific accuracy while ensuring that the final materials meet official ICH presentation and formatting expectations.
| Deliverable stage | Expected activity | Control point |
|---|---|---|
| Technical review | Compare each presentation with ICH Q9(R1) and current QRM training. | Identify conflicts, content gaps, terminology issues, and outdated examples. |
| Revision and agreement | Update content through Training Group co-leads and group review. | Confirm technical consistency across presentations. |
| Secretariat routing | Send completed presentations to the ICH Secretariat. | Editorial review and required edits before publication. |
| Publication | Publish updated materials on the ICH website after required review. | Use the official format and avoid unofficial or conflicting material. |
The document's distinction between revision and publication is useful for any regulated training program. A technically complete slide deck is not necessarily ready for release until document control, editorial consistency, approval, and version management are complete.
Site self-check
ICH Q9(R1) training readiness checklist
- Have local QRM materials been compared with the revised ICH Q9(R1) concepts?
- Do training examples use current terms such as hazard identification?
- Is formality presented as a continuum rather than only formal or informal?
- Are product availability risks addressed where patient access may be affected?
- Do risk decisions show evidence, assumptions, uncertainty, and rationale?
- Are QRM tools explained with limitations and appropriate selection criteria?
- Are human factors and other causal contributors included in investigations?
- Are detection controls credited only when they can trigger a reliable response?
- Are risk assessments linked to URS, DQ, IQ, OQ, PQ, change control, and CAPA where appropriate?
- Are training versions, approvals, and effective dates controlled under the quality system?
Key takeaways
What the 2025 work plan shows
Alignment is the central goal
The Training Group is completing the alignment of older Briefing Pack content with ICH Q9(R1) and newer QRM lessons.
Prioritization makes the work practical
Seven presentations were prioritized before the remaining 11, allowing the most important gaps to be addressed first.
Training is part of the quality system
Updated training should influence procedures, risk records, qualification decisions, investigations, and management oversight.
Publication requires review
Technical revision is followed by ICH Secretariat editorial review before planned website publication.
Clear answers to common questions
Frequently asked questions about the ICH Q9(R1) Training Group
What is the ICH Q9(R1) Training Group Work Plan?
It is a 22 July 2025 plan describing the Training Group's milestones, priorities, and schedule for updating older ICH Q9 Briefing Pack presentations and reviewing selected new Q8/Q9/Q10/Q11 lessons.
When was the Training Group adopted?
The work plan records topic adoption in June 2024, following the Training Group's establishment at the ICH meeting in Fukuoka, Japan.
What did the Training Group continue?
It continued work initiated by the ICH Q9(R1) Implementation Working Group, which operated from September 2023 to July 2024.
How many older presentations were in scope?
The work plan relates to 24 presentations remaining in the ICH Q9 Briefing Pack from 2006, including QRM methods, tools, and application topics.
What was completed by July 2024?
The plan records an introductory QRM and ICH Q9(R1) presentation, a new Q8(R2)/Q9(R1)/Q10 presentation, and revision 5 of the Q8/Q9/Q10 Questions and Answers document.
What was the status of the Q&A revision?
The work plan states that Q&A revision R5 was approved on 30 October 2024 after routing through the Minor Revision Procedure.
Which topics were planned for September 2025?
HAZOP, supporting statistical tools, QRM in regulatory operations, QRM in materials management, and QRM in supply-chain control.
Which topics were planned for December 2025?
The combination of QRM tools; QRM for facilities, equipment, and utilities; development; production; laboratory control and stability studies; and packaging and labelling.
How can a site use the work plan?
A site can compare local QRM training and procedures with current ICH Q9(R1) concepts, prioritize high-impact gaps, update controlled materials, and connect training to qualification, investigations, CAPA, and management review.
Does the work plan replace ICH Q9(R1) or national requirements?
No. It is a training-update work plan. Companies must use the current official ICH text, applicable regulations, and approved site procedures for regulated decisions.
Conclusion
The ICH Q9(R1) training update supports better QRM decisions
The ICH Q9(R1) Training Group Work Plan shows how a global technical training portfolio can be updated through prioritization, expert review, controlled revision, and editorial oversight. Its milestones connect the 2023 revision of ICH Q9 with a practical program to improve older presentations and integrate new QRM lessons.
For pharmaceutical organizations, the central lesson is to keep training aligned with the decisions teams actually make. QRM should be evidence-based, proportionate, connected to product quality and availability, and revisited as knowledge changes. When training, procedures, qualification, data integrity, investigations, and CAPA use the same principles, the quality system becomes more consistent and easier to defend.
Primary source and further reading
Official references and pharmaceutical resources
This article is based on the supplied ICH Q9(R1) Training Group Work Plan dated 22 July 2025. Use current official guidance, national requirements, and approved procedures for live regulatory work.
Educational overview based on the supplied work plan. Always verify the current official ICH publication status before relying on a training presentation.
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