The new ICH Q9 Revision on Quality Risk Management becomes Effective as of 23 July 2023: A Detailed Analysis

Earlier in February you could read about the publication of the revised ICH Q9 guideline. What are the new features of Quality Risk Management (QRM)?

The objectives of the revision were improvements in four areas:

• Subjectivity in QRM risk assessments and outcomes.
• Insufficient management of supply and product availability risks
• Lack of understanding of QRM formalities
• Lack of clarity about risk-based decision making

We had provided very detailed information on the draft revision. What other important changes have now been added to the final document? Please find below a detailed analysis of these changes.

The revision now comprises a total of 25 pages; the original document had 19 pages. Compared to the draft, further subchapters have been added to the table of contents. In addition to the formalities on quality risk management (5.1) and risk-based decision-making (5.2) already mentioned in the draft, a subchapter on management and minimisation of subjectivity (5.3) has now been added. The new subchapter 6.1 The role of QRM in addressing product availability risks due to quality/manufacturing problems, however, only serves to improve the structure. There is little that is new here in terms of content. The new point II.9 Quality risk management as part of supply chain control/management, which already existed in the draft, has also been kept.

The introduction is now more extensive (1.5 pages) than in the original document (1 page). This is understandable, as the newly added parts (subjectivity, shortages, etc.) are now also addressed in the introduction. The change in the risk management process from risk identification to hazard identification is new and unchanged from the draft.

Also new compared to the original document is an additional bullet point on the subject of subjectivity under 4.1. Responsibilities. This was however already included in the draft document. Other than in the draft document and new compared to the original, the passage on subjectivity under 4.1 has now become a separate point 5.3.

Risk Management

In the description of the risk management process, risk identification has become hazard identification in the final document. This is also reflected in chapter 7 Definitions, where risk identification has now been dropped, as in the draft document. A small change was made to risk acceptance, one sentence was removed.

In chapter 5 Risk Management Methods, a new sentence was added in the very first paragraph, which points out that non-discrete factors can play a role in detectability. Therefore, detectability controls are important as they can reduce the probability of occurrence.
In the second paragraph, the reference to informal risk analysis pathways has been deleted. The idea behind this seems to be that it is not a matter of - either informal or formal - but that fluid transitions are possible in terms of risk. This is also explicitly mentioned again in the introduction to Annex I, as could also be read in the draft.

There were also major changes in Chapter 5 Risk Management Methods through the introduction of passages on subjectivity. In the draft document, there were already new subchapters on formalities (5.1), on risk-based decisions (5.2), and now, quite newly, in the final document on managing and minimising subjectivities (5.3). As briefly mentioned above, this is an original passage from 4.1 of the draft document. In general, decision making (5.2.) refers to knowledge management (according to ICH Q10) and also to data integrity in the context of decisions. In the new chapter 5.3, the difficulty of avoiding subjectivity is pointed out and it is recommended to always consider this issue when dealing with suppositions or even bias.

Compared to the draft, there were only relatively few textual adjustments in Chapter 6 on the integration of QRM in industry and authority processes, but a new subchapter, as already described above. Furthermore, a paragraph on the reference to Annex II.2, which can also be helpful in connection with risks to product availability, has been added compared to the draft document and consequently also to the original document.

In general, the references (Chapter 8) , especially quotations of standards, have been updated and new literature references have been added.

Changes in the Annexes

In Annex I on QRM Methods and Tools, there were few changes in general. A spelling mistake in Chapter I.5 (HACCP) is noteworthy: haard(s) is certainly meant hazard(s). In I.9 (Supporting Statistical Tools), the standards listed have been updated with regard to their issue.
In Annex II, the biggest change to the original document is the introduction of Chapter II.9 (QRM as part of supply chain management/control). There were also a few changes to the draft document here, but they are not fundamental.

Conclusion: The objective of the update of the original document regarding improvements in four areas

• Subjectivity in risk assessments and QRM results.
• Inadequate management of supply and product availability risks
• Lack of understanding of QRM formalities
• Lack of clarity on risk-based decision making

has been implemented. Those who have already read the draft document in detail are already well prepared. The changes in the final document to the draft document are not very significant. Now "the ICH" still has the task of producing new training material for the revision, as already announced.

Revision 1 has meanwhile been published on the EMA website and will become valid on 23 July 2023.

P.S.: At the ECA Validation Manager Conference on 29-31 March 2023 in Heidelberg, Germany, the changes brought about by the revision will also be explicitly addressed in a presentation.