ICH Harmonised Quality Risk Management Guideline — Thoughts
International Council for Harmonization (ICH) released a final version of the quality risk management guideline on 18 January 2023.
The guideline provides risk management tools, principles, and a roadmap.
The guideline link can be found here.
The guideline starts with the identification of risk. Risk is defined as the combination of the probability of occurrence of harm and the severity of the harm. These are two considerations when risk management is performed in pharmaceutical companies. For example, in Failure Mode Effects Analysis (FMEA), these are the two considerations for identifying risk. These are the harm and severity of the harm. Possibilities and inferences are discussed.
ICH states that subjectivity must be decreased on the field. But it cannot escape from the subjectivity traps inside its document. The guideline states that Quality risk management must be applied to prevent risks and take precautions about them. Quality risk management should not be used to justify a practice;
…that would otherwise, in accordance with regulations and/or guidance, be deemed unacceptable…
ICH, while trying to harmonize quality risk management falls into the subjectivity trap again. The guideline states that when risk is defined quantitatively, a numerical probability can be used for measurement. When the risk is defined as qualitative, it must be described as “low”, “medium” and “high” risk. There are tools for risk measurement. Such as FMEA, Hazard Analysis, and Critical Control Points (HAZOP), etc. These must be used for introducing measurement. Risk must be objective and objectivity provided by numbers, not letters.
In 4.4 Risk Control chapter guideline states Risk Acceptance. It shows where to stop. It is a decision to accept risk as it is and move on to production. I know that some risks cannot be eliminated from the shop floor. There will also be rejected on the machine. But ICH does not clearly states where to stop. It states that;
In these circumstances, it might be agreed that an appropriate quality risk management strategy has been applied and that quality risk is reduced to a specified (acceptable) level.
What and where is an acceptable level? How can I achieve that? When should I stop?
These questions’ answers are relative.
In 5.1 Formality in Quality Risk Management, the guideline discusses how formal should be the risk assessment. It can be more or less formal due to
- Uncertainty
- Importance
- Complexity
of the risk. Subjectivity trap again. Guideline states that;
The more important a risk-based decision may be in relation to product quality, the higher the level of formality that should be applied, and the greater the need to reduce the level of uncertainty associated with it.
Quote is self-explanatory. But where do we draw the line? How important is much important or how complex is much complex? How can we decide that?
In the light of science, goals, rules and risks must be SMART. Smart, Measurable, Attainable, Realistic, Time-bound. When these achieved on the pharmaceutical industry, quality will be improved once more.
