ICH Q2(R2)，Q14ガイドラインの作成状況と論点解説

抄録

This article describes the drafting process and key points of ICH Q2(R2) (Analytical Validation) and ICH Q14 (Analytical Development). The harmonization effort started in 2018 and the two documents are being drafted by one Expert Working Group. The drafts for public consultation will be published in mid 2021. The revised Q2 will include spectroscopic procedures, procedures used for biologics, multivariate analysis based procedures, etc. The new Q14 will cover Enhanced (Quality by Design) development approach. Q14 emphasizes that the enhanced knowledge supports robust analytical procedures and their effective lifecycle management.