What ICH Q14 - Analytical Procedure Development and Lifecycle Management (2023) requires
ICH Q14 (Step 4, November 2023) establishes a science- and risk-based framework for analytical procedure development, defining Analytical Target Profiles (ATP) and Analytical Procedure Performance Indicators (APPIs) to support enhanced lifecycle management under ICH Q12 and validated performance under ICH Q2(R2).
Pillar: Pharmaceuticals & Life Sciences · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) · Version: 1.0.0 · Last updated:
Primary source: https://www.ich.org/products/guidelines/quality/article/q14.html
SHA-256 integrity: 4badc63c73ac54a545ab7be7933a4e7d3da3873c6de7aab20b9bac227f66b150
Primary Citations — 6 traced to source
- {"title":"ICH Q14 - Analytical Procedure Development (Step 4, November 2023)","url":"https://www.ich.org/products/guidelines/quality/article/q14.html","instrument":"ICH Q14","jurisdiction":"International"}
- {"title":"ICH Q2(R2) - Validation of Analytical Procedures (2022)","url":"https://www.ich.org/products/guidelines/quality/article/q2.html","instrument":"ICH Q2(R2)","jurisdiction":"International"}
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