Since 2005, the ICH Q9 guideline has been state-of-the-art when it comes to quality risk management (QRM) in the GMP environment. Now, it is to be revised. What is planned?
In a concept paper, the ICH has published the plans for the revision of ICH Q9. The reason given for the revision is that the benefits of quality risk management are not yet fully implemented. In particular, digitalisation in the GMP environment and new (emerging) technologies (such as continuous manufacturing and PAT) should also be able to benefit from the revision.
It is planned to develop specific, officially accessible, training material beyond the "briefing pack" which is already available. Developing this training material is mentioned as the main objective of the revision.
Furthermore, there will be specific amendments in selected chapters and annexes, namely in four areas:
High degree of subjectivity in risk considerations and in QRM results: although complete exclusion of subjectivity is not possible, well-known strategies (such as on bias and behavioural patterns) could contribute to control. This applies to Chapters 1 and 4.1 and the development of specific training materials for such strategies and tools.
Product availability: the ICH Q9 guideline is not a supply chain guideline, but the (non-)availability of medicinal products on the market can represent a risk for patients. In future, this topic should be given more attention in Chapters 6 and 7, as well as in Annex II with the addition of a new section (II.9). Furthermore, training materials should also be developed on this subject.
The lack of understanding of the formalities within the framework of the QRM: There are uncertainties in this regard both in the industry and among the regulatory authorities, as the concept paper points out. As part of the revision, Chapters 1 or 5 should therefore be adapted with regard to Annex I. The aim is to describe a more effective application of QRM principles and a better execution of QRM activities. Training material should also be developed.
The lack of clarity on risk-based decisions: according to the concept paper, there is a lack of clarity on what is meant by good risk-based decisions, how QRM can improve decision-making or how to achieve risk-based decisions. Among other things, the expected benefits of investing in risk-based decision-making should be specified. Chapter 1 is to be amended for this purpose and a new section II.10 in Annex II as well as a new reference in Chapter 6 are to be added. As with the other three areas, training material is to be developed.
The concept paper also proposes more clarification on the maintenance of risk assessments and the implementation of the risk review. The risk review should also be linked more with continuous improvement, as mentioned in ICH Q10, and life cycle management from ICH Q12/14.
Furthermore, the term risk identification should be exchanged for hazard identification in Chapter 4.3. This will also result in a change to Figure 1 of the Guideline on the QRM process.
The finalised revision should be available by July 2022. A detailed timetable can be found in the Business Plan. You can find the concept paper on the EMA website.