Analytical Method Validation
Plans, executes, and documents validation, verification, and transfer of analytical...
Install
npx skills add K-Dense-AI/scientific-agent-skills --skill analytical-method-validation -g -a claude-code -y- Repository
- K-Dense-AI/scientific-agent-skills55.7k
- Category
- Testing
- Updated
- 9d ago
- License
- MIT
- Context cost
- Mediumabout 3,000 tokens
- Runs scripts
- Yes, review before use
What it does
Plans, executes, and documents validation, verification, and transfer of analytical procedures under the governing framework - ICH Q2(R2) and Q14, USP <1220>/<1225>/<1226>, ICH M10 bioanalytical, CLSI EP, or ISO/IEC 17025. Use for HPLC, LC-MS/MS, GC, CE, ICP-MS, dissolution, qNMR, qPCR, NIR, and ligand binding or cell-based assays whenever the question is whether a procedure is fit for its intended purpose. Triggers include "method validation", "analytical method validation", "AMV", "validation protocol", "acceptance criteria", "linearity", "reportable range", "accuracy and precision", "repeatability", "intermediate precision", "recovery", "LOD", "LOQ", "detection limit", "quantitation limit", "specificity", "robustness", "method transfer", "method comparison", "Deming", "Passing-Bablok", "Bland-Altman", "equivalence testing", "OOS investigation", "ICH Q2", "Q2(R2)", "Q14", "USP 1225", "ICH M10", "incurred sample reanalysis", "ISR", "CLSI EP", and any request to show that an assay works.
Analytical Method Validation
When to use
Any time the question is whether an analytical procedure is fit for its intended purpose: designing a validation study, evaluating validation data, verifying a compendial procedure, transferring a procedure to another laboratory or instrument, or defending any of these in a report.
The two rules
1. Establish which framework governs before designing anything. The same assay validates differently under ICH Q2(R2), USP <1225>, ICH M10, CLSI EP, and ISO/IEC 17025. They differ in which characteristics are required, how the studies are laid out, and whether numeric acceptance criteria are supplied at all. Blending them produces a protocol that satisfies none of them.
2. State acceptance criteria before collecting data. Criteria chosen after seeing results are not acceptance criteria, and deciding them post hoc is a standing audit finding. ICH Q2(R2) deliberately supplies almost no numeric criteria, they have to come from the specification, the analytical target profile (ICH Q14 section 3), or development data. ICH M10 is the exception: it supplies explicit numbers, and they differ between chromatographic assays and ligand binding assays.
Scope
This skill plans studies, computes the statistics correctly, and structures the documentation. It
does not decide that a procedure is validated, release a batch, accept or reject a run, close
an investigation, or substitute for the analyst, the technical reviewer, the quality unit, or the
regulator. Every script reports computations and supported findings; only the responsible reviewers can
make the fitness-for-purpose decision. JSON uses null for unavailable statistics.
