ICH publishes Training Modules on "ICH Q3D - Elemental Impurities"

The ICH has published the long-announced training modules on the ICH Q3D Guideline "Elemental Impurities". Recently, seven presentations (in one zip file) have been put on the ICH website. The presentations deal with the following topics from the Q3D Guideline:

  • Module 0: Overview of modules 1 to 9
  • Module 1: Developing acceptable levels for other routes of administration
  • Module 2: Justification for exceeding a Permitted Daily Exposure (PDE)
  • Module 3: Developing acceptable levels for elemental impurities not covered by ICH Q3D
  • Module 4: Considerations for large volume parenterals
  • Module 5: General approaches to risk assessment
  • Module 6: Controls on elemental impurities
  • Module 7: Calculations between PDE values and concentration limits

The training modules 8 (three examples of a presentation for a risk assessment) and 9 (FAQs) are still in progress and will be published soon.
ICH's "Implementation Working Group" which was formed in October 2014 is in charge of the creation of these modules.  It has already elaborated similar training modules for the ICH Q8 - 10 Guidelines and one Q&A document for ICH Q11.

The background for the development of the training modules on "Elemental Impurities" is the complexity of the requirements laid down in the Q3D Guideline. This became apparent during its development stage. Many critical comments from companies and industrial associations - mainly during the consultation phase of the guideline -  led the ICH to develop practical assistance to both the industry and the authorities in order to ensure a smooth implementation of the guideline.

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