Expert Working Group submits Comments to ICH Q9 Draft


Since 2005 at the latest, quality risk management has dominated almost the entire GMP sector. At that time, the corresponding ICH Q9 guideline was published as "Step 4".

In December the draft of a planned revision has been published. According to an ICH presentation the Guideline has been revised to address the following:

  • “The QRM principles and framework of ICH Q9 have been instrumental in introducing QRM approaches to both industry and regulators. However, the benefits of QRM, as envisaged by ICH Q9, have not yet been fully realized.
  • There are four areas for improvement with the current application of QRM:
  • High levels of subjectivity in risk assessments and in QRM outputs
  • Failing to adequately manage supply and product availability risks
  • Lack of understanding as to what constitutes formality in QRM work
  • Lack of clarity on risk-based decision-making
  • Guidance has been developed for each of these four areas; this new guidance has been inserted into various chapters and annexes of the current guideline.
  • The new guidance will be supported by the development of official ICH training materials – these materials will include case studies to help illustrate the key points in the guidance.”

The ECA Foundation and its European QP Association have set up an Expert Working Group led by Yves Samson and with the members

  • Britta Abellan
  • François Croizet, PQE France
  • Jérôme Keldenich, Cenexi
  • Philippe Lenglet, Laboratoires Servier
  • Véronique Dagois, Capexpert
  • Jean-Denis Mallet, Pharmaplan
  • Éric Villain

to comment on the draft revision of the ICH Q9 Guideline. To find out more about the comments that were submitted, please see the following documents.

ICH Q9 – R1 Draft – Quality Risk Management (EMA/CHMP/ICH/24235/2006) – Comments from ECA Foundation and Europeam QP Association
Comparison Initial version (2005'11) versus Revision 1 Draft (2021'11)
Comparison Initial version (2005'11) vs Commented Revision 1 Draft (2021'11) vs Consolidated R1

For the draft, please also see the ICH guideline Q9 (R1) on quality risk management - Step 2b.

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