The ICH Q9 Briefing Package - a Forgotten Document?

Due to Revision 1 of the ICH Q9 document on quality risk management, the ICH has published extensive training material on the "main text" of the revised Q9 guidelines. However, even the revised version of ICH Q9 (R1) still has two annexes. Annex I describes quality risk methods and tools. Annex II describes possible applications of quality risk management (QRM). As there have been few changes to these two annexes, the training slides ICH published as a "Briefing Package" in 2006 are still available on the ICH website. Are they still up to date?

As with the training material for the "main text", some of the slides are very extensive. For Annex I, every risk method mentioned in the guideline is also provided with training slides:

• Overview of ICH Q9(R1), with 75 slides. Here the revision of ICH Q9 is explicitly discussed again, a new set of slides in the "Briefing Package".  
• Overview of Annex I, with 13 slides
• Methods to support risk management (11 slides). Among other things, flow charts, checklists, process mapping and Ishikawa diagrams are included.
• FMEA/FMECA (32 slides), including practical examples from the industry. Two slides also include notes on FMECA.
• FTA, with 11 slides
• HACCP (8 slides), with an interesting slide in which the HACCP concept is embedded in the ICH Q9 risk management process
• HAZOP (7 slides), with a slide presenting the "guide words" for HAZOP analyses
• PHA (5 slides) with, among other things, a slide showing a risk matrix
• "Risk Ranking and Filtering" (14 slides), also with examples from the industry (Roche, Eisai).
• Supporting statistical tools (22 slides) with examples of control charts, Design of Experiments (DoE), Pareto charts and process capability analyses
• Combination of tools (10 slides), this title is not mentioned in Annex I. Interestingly, there are 5 slides where "Züricher Versicherung" (an insurance) is mentioned as a source.

For Annex II, each QRM application mentioned in the guideline is also provided with training slides:

• Potential applications of Annex II (18 slides), with an interesting slide on the application of ICH Q9 for excipients.
• Integrated quality management (42 slides), addressed in the slides are documentation, training, quality deficiencies, audits/inspections, periodic review, change management/control and continuous improvement.
• Regulatory activities (4 slides) with a reference to the previous chapter
• Development (16 slides) with a note to also consider the following chapters and a practical example regarding the identification of critical attributes
• Materials and equipment (42 slides) with very extensive practical examples
• Material management (5 slides)
• Production (4 slides)
• Laboratory controls (2 slides)
• Packaging and labeling (3 slides)

Another new feature is an update of the training materials for implementing the ICH guidelines ICH Q8, Q9, Q10.

Conclusion: Although it dates back to 2006, the "Briefing Package" for Annex I and II of the ICH Q9 (R1) guideline is still up to date. Unfortunately, the new chapter in Annex II of Revision 1 on supply chain management has not (yet?) been supplemented with training slides. 

You can find the entire "Briefing Package with PowerPoint slides" on the ICH website. Fortunately, there is also an overview document that shows all slides, each divided into 6 slides/page. This can also be found on the ICH website.