ICH - Training Programme for Q8/Q9/Q10

14th November 2024

ICH - Training Programme for Q8/Q9/Q10

This training material is comprised of a comprehensive presentation which addresses the implementation of the three guidelines, ICH Q8(R1), ICH Q9(R1) and ICH Q10, and how they work together.  The material is based in part on unofficial presentations and workshop materials that were developed in 2010 by several members of the ICH Q8/9/10 Implementation Working Group (IWG), which was in operation at that time, as well as on learnings made since 2010 in relation to the use of the three guidelines.  The training material also reflects the revisions that were made to the ICH Q9 guideline, as published in 2023.  

This training material is relevant for pharmaceutical companies involved in the manufacture of APIs (small and large molecules) and drug (medicinal) products, as well as industry parties involved in development, manufacturing, quality and regulatory affairs.   It is also relevant for regulators responsible for dossier assessments and GMP inspections.

The training material shows how the three guidelines work together as building blocks in a lifecycle framework for the Pharmaceutical Quality System.  The material illustrates how the trio of guidelines supports appropriate risk-based decision making, starting at the drug development stage and continuing throughout the entire product lifecycle. The guidelines help ensure: 

• Science and risk-based product and process development;
• Successful technology transfer;
• Continual improvement throughout the commercial lifecycle to ensure a continued state of control.

Training Materials

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