Author: Kate Coleman Senior Director/Principal Consultant at PharmaLex
ICH Q9 Quality Risk Management was first published in 2005 and a long-awaited revised draft was released for public consultation in November 2021.
The first few paragraphs of the updated guidance are promising with an emphasis on the diverse stakeholders that may be involved in risk management within the Pharmaceutical Industry, and how this diversity may lead to subjectivity in risk assessment execution. However, the draft guideline makes it very clear that the protection of the patient is the primary goal of Quality Risk Management (QRM) and we protect the patient through assurance of product quality and availability.
The draft proceeds to describe how product quality is assured through the application of appropriate risk-based decision making throughout the product lifecycle and that the attributes that are important to the quality of the drug, also known as Critical Quality Attributes or CQAs, must be maintained. This wording is welcome in terms of the clarity of the draft as it is clear that when implementing Quality Risk Management, we must first understand our product CQAs and identify risks across the product lifecycle that would negatively impact these CQAs.
The draft guidance explains how Quality Risk Management is a proactive approach, facilitating continuous improvement and providing a basis for risk-based decision making which, when implemented appropriately, can reduce the level of regulatory oversight required.
The basic principles of Quality Risk Management have not changed and it still stands that evaluations of risk should be based on scientific knowledge, and ultimately link to the protection of the patient. Also, the level of effort and formality should be commensurate with the level of risk. These fundamentals thankfully remain unchanged but the draft revision has emphasised that patient safety and product quality are firmly placed at the heart of any Quality Risk Management program.
The topic of bias and subjectivity in Quality Risk Management has been appropriately highlighted and addressed throughout the draft. The requirements for definition of the risk question and documentation of assumptions, acknowledgment of bias/subjectivity and the identification of poorly defined risk scoring scales as a source of subjectivity, all align with our experience with the remediation and improvement of our clients’ Quality Risk Management programs.
The draft ICH Q9 is a welcome improvement over the existing guidance. However, there are areas that could have been further detailed and explored, such as the link between maturity of prospective risk assessments and a reduction in deviations. Also, the importance of the revision of existing risk assessments over the constant generation of new documents could have been further emphasized. For example, revision of an existing prospective process risk assessment will provide more information on the impact of a major change than the commencement of a new change specific risk assessment.
The guidance regarding risk-based decision making is also a welcome new addition and highlights the importance of the discussion of risk in any decision making process. It would have been helpful for risk-based decision making to be identified in this document as something that is human nature rather than a process unique to our industry. Risk based decision making, particularly over the last two years is an inherent part of how we think and ensures we make decisions that keep us safe. The only difference when we move into the work environment is that these risk-based decisions impact and protect our patients rather than ourselves.
If you would like support with the design, implementation or improvement of your Quality Risk Management program, please connect with us – contact@pharmalex.com
The link to the new guidance is here.
