Friday 11 December 2020

ICH Q9 in revision


A revision to ICH Q9 Quality Risk Management (QRM) has been recently approved by the ICH Management Committee. 

Training materials supplementing ICH Q9 and revisions will be developed.  Four areas for improvement are identified:

1.      High levels of subjectivity in risk assessments and in QRM outputs. Highly subjective risk-scoring methods and assessments by stakeholders can lead to varying levels of QRM effectiveness.  Revisions of specific sections and development of training materials with strategies and tools are planned.

2.      Product availability risks.  Emphasis on product quality issues affecting the supply chain predictability will be addressed.  New sections on use of QRM in supply chain control, product availability discussion, and training materials are planned.

3.      Lack of understanding as to what constitutes formality in QRM work. Deeper understanding of formality to lead to more effective application and execution of QRM activities is needed.  Confusion and uncertainty in interpretation of formality currently exists.  Degrees of formality, factors for consideration, and related training are planned.  Understanding the

4.      Lack of clarity in risk-based decision-making. Clarification of the meaning of good decision-making, use of QRM to improve decision-making, and how risk-based decisions are achieved is needed.  Application of information from other industries is available.  New sections and revisions with training are planned.


Other points:


·         Risk Identification terminology to be changed to “Hazard Identification” for better relationship to patients and how hazards are perceived and assessed.


The revised guideline and training materials are targeted for completion in June 2022.


See IVT for details:


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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