What ICH Q2(R2) - Validation of Analytical Procedures: Methodology and Acceptance Criteria (2022) requires
ICH Q2(R2) (Step 4, November 2022) updates the 1994 Q2(R1) validation guideline by integrating life sciences analytical techniques (biological assays, spectroscopic methods, multivariate analysis), defining validation performance parameters with numerical acceptance criteria, and aligning validation strategy with ICH Q14 Analytical Target Profile principles.
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/q2.html
SHA-256 integrity: 9a1c1e8b791c368acc094da7bf91b3499aff94e09703f64141b1f6e1ef873b82
Primary Citations — 6 traced to source
- {"title":"ICH Q2(R2) - Validation of Analytical Procedures (Step 4, November 2022)","url":"https://www.ich.org/products/guidelines/quality/article/q2.html","instrument":"ICH Q2(R2)","jurisdiction":"International"}
- {"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"}
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