ICH releases Q9 training materials on quality risk management
The International Council on Harmonization (ICH) has issued training materials to complement its revised Q9(R1) guideline on quality risk management aimed at assisting the pharmaceutical industry in navigating the newly revised guideline.The guideline was published in January 2023 and updates the original document, which had been in effect since 2005 (RELATED: ICH adopts guidelines on quality risk management, Regulatory Focus 25 January 2023).
The training materials use examples and case studies to explore in more detail some of the concepts introduced in the guideline. The revised guideline introduced new principles on minimizing subjectivity in risk assessments, clarified what is meant by the term “formality” in risk assessments, and spelled out what is meant by good risk-based decision making.
In a March 2023 presentation, ICH said that clearing up these ambiguities was essential. The group noted that the revision tackled four areas in need of improvement:
- high levels of subjectivity in risk assessments
- failure to address supply and product availability risks
- lack of understanding is as to what constitutes formality in quality risk management (QRM) work
- lack of clarity on risk-based decision-making
The training materials include nine modules covering formality training, hazard identification, product availability, risk review training and subjectivity training.
The formality module addresses some of the factors that can be used to determine the formality of risk assessments, such as the degree of uncertainty and the complexity of the manufacturing process. The module also offers some examples of a formal risk assessment program.
The topic of hazards in risk assessments is covered in another module, which also provides illustrative examples of failure mode strategies used to identify hazards.
Another module addresses how to control and identify subjectivity in risk assessments and discusses why subjectivity in QRM can be a problem. It also offers tips and examples for controlling subjectivity.
The module on risk reviews discusses what to evaluate during a risk review and offers recommendations on how frequently risk reviews should be conducted.
The module on product availability discusses factors that affect product availability, product quality and supply dependability.
ICH presentation on Q9
