ICH Q2(R2) – the latest ICH guideline for analytical procedures validation

ICH Q2(R2) – the latest ICH guideline for analytical procedures validation

Presentation

Information

After almost two decades, ICH Q2(R1) guideline on validation of analytical procedures have been revised to integrate knowledge management principles while broadening its applicability to encompass a diverse array of technologies and address multivariate procedures helping support the validation of Real Time Release testing (RTRT). ICH Q2(R2) became official in November of 2023 and this session will:

  • Outline key changes in ICH Q2(R2)
  • Examine the risk-based approaches for validation of analytical procedures
  • Explore how the new guidelines align with other international recommendations
  • Explore the implications of Q2(R2) to industry.

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