The European Medicines Agency (EMA) has released the comments of the ICH guideline Q9 (R1) draft from December 2021 (link). The document describes principles and examples of tools for quality risk management and consists of 56 pages of comments from organizations such as the PDA, EFPIA and many others.
In the next step of the revision of ICH Guideline Q9, the comments are now being reviewed and further processed by The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Since 2005 at the latest, the topic of quality risk management has dominated almost the entire GMP sector. The draft of a revised document was published in December 2021 by the ICH and by the European Medicines Agency (EMA). On the ICH webpage a slide deck about the revision of ICH Q9 is available. With 33 pages, the draft is significantly more extensive than the previous version with 19 pages. Changes are partly reflected in the table of contents, which contains new elements in the form of subchapters 5.1 Formalities in quality risk management and 5.2 Risk-based decision making and II.9 Quality risk management as part of supply chain control/management. Likewise new in the table of contents is the title of Annex II with Quality Risk Management as Part of an Integrated Quality System, as well as the new subchapter II.9 Quality Risk Management as Part of Supply Chain Control/Supervision. Especially the topics subjectivity, formalities in quality risk management and risk-based decision making are new aspects. Quality risk management as part of supply chain control/management is also planned as an innovation.
The most extensive changes are also pointed out in the introduction. For example, the issue of subjectivity is addressed in the context of risk management activities and the resulting decisions. Furthermore, appropriate risk-based decision making during the product life cycle and formality aspects related to quality risk management are addressed in the introduction. Basically, the introduction already summarizes the formality aspects described quite extensively in Chapter 5: little formalism for low risks, more formalism for higher and more complex risks. The introduction concludes with the statement that quality risk management should not be used to justify decisions that run counter to official guidelines and/or regulations.
The risk management process itself undergoes a minor change: risk identification becomes hazard identification. The remaining terms remain unchanged.
Under point 4.1 Responsibilities, a new section has been added on the subject of subjectivity. Possible causes for subjective decisions and prevention strategies are briefly addressed, as well as the hint that subjectivity in the quality risk management process should be addressed in the team.
Formalities in quality risk management are described very extensively in point 5.1. As already briefly mentioned in the introduction, the degree of formality should depend on the degree of risk and can vary. So it is not about formal versus non-formal, but about smooth transitions. Criteria to be considered for the degree of formality are:
Furthermore, examples of criteria that characterize a higher or lower degree of formality are listed.
The new chapter 5.2 on risk-based decision making describes 3 scenarios regarding highly structured, medium structured and standardized structuring (e.g., via an SOP). Newly included is the topic of supply chain complexity regarding drug shortages. This is already included in Chapter 6 (Integrating Quality Risk Management into Industry and Regulatory Processes), but is also covered in the new section of the same chapter on the role of quality risk management in relation to product availability risks. Problem areas that are addressed are:
- manufacturing process variations and control status;
- manufacturing premises;
- overview of outsourced activities and suppliers.
In Chapter 7, two more definitions were added (Hazard Identification and Risk-Based Decision Making), and definitions, coming from the original version, were removed. References were updated (updated citations and new citations). Annex I on Quality Risk Management Methods and Tools also reiterates the potential variability in formalities.
In Annex II, with a new title, Quality Risk Management as Part of an Integrated Quality System contains a new subchapter II.9 Quality Risk Management as Part of Supply Chain Management/Control. The problem areas already mentioned above are addressed once again.