New skill for bench analytical scientists in regulated labs: planning,
evaluating, and documenting validation, verification, and transfer of
analytical procedures under whichever framework governs.
Frameworks. ICH Q2(R2) and Q14 and ICH M10 are encoded directly from their
openly licensed text, read from the adopted PDFs rather than from secondary
summaries. USP <1220>/<1225>/<1226>, the CLSI EP series, and ISO/IEC 17025 are
paywalled, so they are cited by designation and scope only and never
reproduced or reconstructed; edition numbers taken from listings rather than
the documents are marked for confirmation.
Q2(R2) content covers the restructured characteristics (range as the parent of
response and lower range limits), Table 1 tests by measured attribute, Table 2
reportable ranges, the recommended-data minima, and the 30 Nov 2023 error
correction. M10's chromatographic and ligand-binding-assay criteria are kept
strictly separate, including the LBA-only total-error limit and the differing
ISR tolerances.
Scripts. Six standard-library CLIs, no numpy and no network, computing the
statistics that decide fitness for purpose rather than the ones that look
reassuring:
- plan_validation.py framework selection and a protocol whose
acceptance criteria must be pre-stated
- check_response.py lack-of-fit F against pure error, residual runs
test, back-calculated error per level, and a
heteroscedasticity check for weighting
- check_accuracy_precision.py recovery with confidence intervals, and
precision decomposed per level into repeatability
and intermediate precision
- check_detection_limits.py DL/QL by every approach Q2(R2) allows, compared
against the reporting threshold
- check_bioanalytical_run.py M10 run acceptance including the per-level QC rule
- compare_methods.py Deming and Passing-Bablok regression plus TOST
equivalence against a pre-stated margin
Distributions are built from the regularised incomplete beta and gamma
functions and checked against published quantiles.
Scope. The skill reports and computes. It does not decide that a procedure is
validated, accept or reject a run, close an investigation, or replace the
analyst, technical reviewer, quality unit, or regulator.
Also adds 111 tests in tests/analytical-method-validation, a docs/skills.md
entry, examples.md Example 36b, and updates the README skill count to 156.
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