ICH Q3 — Impurities
ICH Q3 — Impurities — 50% of in-scope requirements covered.
2 requirements · 1 in scope (1 designed) · 1 out-of-scope (outside KYE™’s authority layer). The 50% is weighted over the in-scope base.
ICH Q3: requirement → the KYE™ artefact that enforces it
Demo dataYou learn: Which requirements KYE™ enforces at runtime and with which artefact. You can: Walk the requirements.
-
named-authority · designed
AI-generated impurity-assessment summary proceeds only under a recorded named-authority decision
Rule packs: kye:rule-pack:ich-authority · Constitution: 12 purpose permission
-
science · out-of-scope
Impurity science & threshold determination
(no enforcement cited)
How this widget is built
- Demonstrates
- KYE™ Compliance Mapping Rail™
- Components
- Framework requirement (clause)
- Coverage status
- KYE™ enforcement artefact (event, decision-record field, Evidence Pack™ entry)
- Flow
- Clause → status → the KYE™ artefact that enforces it, enforced requirements first. Architecture diagram
- Used on
- /compliance/ich-q3/: On every framework page, after its opening.
Source: The Impurities guideline (ICH Q3 — Impurities) defines the ICH Q-series quality expectations for impurity thresholds. KYE Protocol™ governs whether an AI-generated summary in this area may PROCEED to a consequential action — reliance in a dossier or Quality-Unit approval — under a named authority, with the justification recorded before the action and replay-provable provenance. KYE™ does not perform the underlying science or judge whether the quality is acceptable. · License: ICH guidelines are published by the International Council for Harmonisation; KYE™ registry paraphrases each requirement's intent and cites the official identifier for mapping purposes only.
By category
| Category | Reqs | Enforced | Designed | Advisory | Deferred | Coverage |
|---|---|---|---|---|---|---|
| Authority over an AI impurity-assessment summary at the action boundary | 1 | 0 | 1 | 0 | 0 | 50% |
| Impurity science & threshold determination | 1 | 0 | 0 | 0 | 0 | 0% |
Every requirement → the KYE™ artefact that enforces it
| ID | Title | Status | KYE™ enforcement |
|---|---|---|---|
ich-q3.named-authority | AI-generated impurity-assessment summary proceeds only under a recorded named-authority decision | designed | rule_packs: kye:rule-pack:ich-authoritydictionaries: internalconstitution_refs: constitution/12-PURPOSE-PERMISSION.md |
ich-q3.science | Impurity science & threshold determination | out-of-scope | (no enforcement cited) |
Canonical KYE™ surfaces referenced on this page: KYE Protocol™.