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EMA: ICH Q9 on Quality Risk Management in Step 2b

EMA: ICH Q9 on Quality Risk Management in Step 2b

On 16 December 2021, EMA published the ICH Q9 draft document on Quality Risk Management (QRM) in step 2b. The draft provides important additional guidance on four specific areas:

  • the levels of subjectivity in risk assessments and in QRM outputs,
  • the product availability risks,
  • the lack of understanding as to what constitutes formality in QRM work, and
  • the lack of clarity on risk-based decision-making.

In more detail:

As stated in the document, subjectivity can directly impact the effectiveness of risk management activities and the decisions made. While subjectivity cannot be completely eliminated from quality risk management activities, it may be controlled with the proper use of quality risk management tools and maximising the use of relevant data and sources of knowledge.

An effective pharmaceutical quality system drives both supply chain robustness and sustainable GMP compliance. It also uses quality risk management and knowledge management to provide an early warning system. This includes

  • an internal and external manufacturing process variation and state of control
  • a robust facility infrastructure with suitable equipment and well-designed facilities
  • the use of modern technology, such as digitalization, automation, isolation technology
  • an effective monitoring strategy for supply chain partner performance

An understanding of formality in QRM can help to use resources more efficiently and can also support risk-based decision-making. This topic is addressed comprehensively, highlighting the fact that formality in quality risk management is not a binary concept (i.e. formal/informal), but includes varying degrees of formality. Those should be described within the quality system.

When formal QRM is applied, it should be complemented with structured decision-making. In general, higher levels of formality require higher levels of structure. Still, there can be varying degrees of structure with regard to approaches for risk-based decision-making.

The draft document is currently open for public consultation until 15 March 2022.


EMA: ICH guideline Q9 on quality risk management, Step 2b