ICH Q9 Training Package updated

With the revision of the ICH Q9 guideline "Quality Risk Management 2023", the accompanying training material was also published. This has now been updated to reflect the two annexes in the ICH Q9 guideline. Annex I describes quality risk methods and tools, and Annex II describes possible applications of quality risk management (QRM). An overview is provided below.

As with the training material for the 'main text', some of the slides are very comprehensive. For Annex I, every risk method mentioned in the guideline is specifically accompanied by training slides.

• The slide sets begin with an introduction to ICH Q9(R1), comprising a total of 75 slides divided into two parts. Part I describes the fundamentals and key concepts. Part II describes the structure of the guideline. It is expressly noted that ICH Q9(R1) is not a standalone guideline, but should be read in conjunction with other guidelines. Consequently, for further information, reference is made to other materials in the briefing packages for ICH Q8, Q10 and Q12, as well as to the Q&A document on ICH Q7.
• The next set of slides covers methods to support risk management and, with 28 slides, is significantly more extensive than the previous one (11 slides). These include flowcharts, checklists, process mappings, Ishikawa diagrams, mind maps and Pareto charts.
• FMEA/FMECA is covered in 28 slides, including practical examples from industry. The advantages and disadvantages of the method are also discussed. This is actually 4 slides fewer than in the original version (32 slides)
• Regarding Fault Tree Analysis (FTA), 11 slides outline the advantages and disadvantages, as well as the 6 steps that an FTA should include. The method is typically used as part of root cause analysis. The number of slides has remained unchanged.
• The Hazard Analysis and Critical Control Points (HACCP) method is now explained over 30 slides (in the original version there were only 8 slides). Express reference is also made to WHO document number 908 and Annex 7 therein. The typical 7 steps of an HACCP are clearly explained, as are the advantages and disadvantages of the method.
• The slides on Hazard and Operability Analysis (HAZOP) are also much more comprehensive, with 30 slides compared to the previous version (7 slides). The focus is on the 5 steps with the 'guidewords' within the framework of HAZOP analyses. These slides also address the advantages and disadvantages of the method and present a case study. Furthermore, reference is made to IEC 61882.
• The set of slides on Preliminary Hazard Analysis (PHA) has also been expanded to 18 slides (originally 5 slides). A case study is also presented across 5 slides. The advantages and disadvantages of this method are also outlined on a single slide.
• The set of slides on 'Risk Ranking and Filtering' has also been expanded from 14 slides to 22 slides. The advantages and disadvantages of this method are also presented, and implementation options are demonstrated using two examples (audit frequency, identification of quality parameters for excipients). Unfortunately, the examples from industry (Roche, Eisai) have been removed.
• The slide set on "supporting statistical tools" has been expanded from 22 slides to 34 slides. It includes examples of control charts, Design of Experiments (DoE), histograms, Pareto charts and process capability analyses. The differences between CpK and PpK are also discussed.
• The final set of slides on methods for combining tools has also been expanded from 10 slides to 18 slides. Interesting examples of combinations are now presented. These include FTA combined with HACCP, Ishikawa combined with FMEA, and Ishikawa combined with a Pareto analysis and an FMEA. New additions include slides on probabilistic risk assessment within the slide set.

Regarding Annex II, every QRM application mentioned in the guideline is also supported by new training slides:

• The slides on potential applications of Annex II have actually been reduced to a total of 58 slides (originally 60 slides). Topics covered include integrated quality management, documentation, training, quality defects, audits/inspections, periodic review, change management/control and continuous improvement. Here, the slide compilation is very similar to the original.
• The slide set on the application of quality risk management with regard to regulatory activities has more than increased tenfold to 46 slides (originally 4 slides). Of particular interest are the 8 examples (including the FDA Site Selection Model and inspection planning in accordance with PIC/S).
• The slide set on the topic of development has also 'shrunk' slightly to 11 slides (originally 16 slides) and includes a case study on establishing a control strategy for a tableting process.
• The set of slides on quality risk management for premises, equipment and support systems ("utilities") comprises 33 slides with very comprehensive practical examples (design, qualification - covering a total of 8 slides - calibration and computers).
• The slide set on materials management has also increased tenfold, from the original 5 slides to 50 slides. Three examples cover active ingredients, excipients and single-use products.
• The number of slides on production has quadrupled from 4 to 16. The focus is on the topics of validation, in-process controls and process controls.
• The set of slides on laboratory controls and stability studies has been expanded from 2 slides to 14 slides, divided into two parts. The first part deals with the potential application of quality risk management in the event of OOS results. Part two deals with the potential application of quality risk management in defining appropriate material testing strategies.
• The slides on packaging and labelling have also been expanded from 3 to 26 slides. Topics covered include the application of quality risk management in the design of secondary packaging, the application of quality risk management in the selection of a closure system, and the application of quality risk management in relation to label controls. Two case studies on managing product risks caused by sunlight and an incorrect blister film conclude the set of slides.
• Completely new are 10 slides on the topic of quality risk management as part of the supply chain. These slides were previously missing, as this very topic was newly included in the revision of the ICH Q9 guideline 2023. But now they are available.

Conclusion: The update to the training slides is, in some cases, very extensive. The slides are certainly worth being using for training sessions.

All slides are available on the ICH website.