ICH Q9(R1) Reaches stage 4 and is formally adopted

With an aim to make the pharmaceutical industry's quality risk management (QRM) more robust and to reduce costs, the International Council for Harmonization (ICH) revised Q9 guideline has now finally reached step 4 of the process. Therefore it is now adopted by the ICH Regulatory Members of the ICH Assembly as an ICH Harmonised Guideline.

The ICH Q9(R1) guideline was published on the European Medicines Agency (EMA) website on 16 December 2021 and comments were being accepted up until 15 March 2022. This latest revision was intended to address four specific issues with the previous revision which was in place for over 16 years. These were:

·??????High levels of subjectivity in risk assessments and in QRM outputs,

·??????Failure to adequately manage supply chain and product availability risks,

·??????Lack of understanding as to what constitutes formality in QRM work,

·??????Lack of clarity on risk-based decision making.

The revised guideline introduces new text acknowledging that some degree of subjectivity in risk management is unavoidable, while offering methods to reduce or control subjectivity. ?The guideline states that while subjectivity cannot be completely eliminated from quality risk management activities, it may be controlled by addressing bias, the proper use of quality risk management tools and maximising the use of relevant data and sources of knowledge.

All personnel involved with QRM activities should now anticipate and acknowledge subjectivity and should ensure that such subjectivity is controlled and minimised to allow for robust risk-based decision making.

The revision also includes a new section on formality in quality risk management. According to the guideline, there is a lack of understanding as to what constitutes formality in QRM, and how this area has the potential to be further developed. The guideline goes on to state that an understanding of formality in quality risk management may lead to resources being used more efficiently, where lower risk issues are dealt with via less formal means, freeing up resources for managing higher risk issues and more complex problems that may require increased levels of rigour and effort.

Product availability is also now also addressed in this revision.?Any quality or manufacturing issues and GMP deviations will often lead to product shortages or supply chain constraints. Therefore, companies should consider shortage prevention and mitigation activities that help to limit supply constraints, manage supply chain complexities, and prioritise patient access to needed medicines. An effective QMS where QRM principles are properly embedded will drive supply chain resilience and consistent GMP compliance.

Finally, risk-based decision-making is now addressed in this revision, with detail on how factoring an assessment of risk into decisions can be beneficial. ?Also within the revised guideline, the term “Risk Identification” has been replaced with “Hazard Identification,” to harmonize with discussion in the risk assessment portion of the guidance.

The adoption of this revised guideline for quality risk management is a big step forward for the pharmaceutical industry. The new guidelines are more science-based and robust, which means that there will be less subjectivity in QRM outputs. This will lead to more scientifically based manufacturing operations, control strategies, and validation activities. This will result in fewer quality defects and recalls for patients, and potentially in reduced costs for the pharmaceutical industry.

If your company has fallen behind in managing your Quality Risk Management processes or in preparing individual Risk Assessments to ensure your company meets all regulatory expectations, then now might be the time for a thorough review of your risk management process.

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