Skills for Real Engineers. Straight from my .agents directory.
39 skills
analytical-method-validation
Agent skill from
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 work
How to install analytical-method-validation
install analytical-method-validation
# install the scientific-agent-skills pack with the skills CLI
npx skills add K-Dense-AI/scientific-agent-skills# or add only this skill to Claude Code: copy the folder
skills/analytical-method-validation/
# into
~/.claude/skills/analytical-method-validation/ (all projects)
.claude/skills/analytical-method-validation/ (one project)
1# Analytical Method Validation23## When to use45Any time the question is whether an analytical procedure is fit for its intended purpose:6designing a validation study, evaluating validation data, verifying a compendial procedure,7transferring a procedure to another laboratory or instrument, or defending any of these in a8report.910## The two rules1112**1. Establish which framework governs before designing anything.** The same assay validates13differently under ICH Q2(R2), USP <1225>, ICH M10, CLSI EP, and ISO/IEC 17025. They differ in14which characteristics are required, how the studies are laid out, and whether numeric acceptance15criteria are supplied at all. Blending them produces a protocol that satisfies none of them.1617**2. State acceptance criteria before collecting data.** Criteria chosen after seeing results are18not acceptance criteria, and deciding them post hoc is a standing audit finding. ICH Q2(R2)19deliberately supplies almost no numeric criteria — they have to come from the specification, the20analytical target profile (ICH Q14 section 3), or development data. ICH M10 is the exception: it21supplies explicit numbers, and they differ between chromatographic assays and ligand binding22assays.2324## Scope2526This skill plans studies, computes the statistics correctly, and structures the documentation. It27does **not** decide that a procedure is validated, release a batch, accept or reject a run, close28…
Excerpt shown under the repository's MIT license.
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