ICH Q6 — Specifications
ICH Q6 — Specifications — 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.
Source: The Specifications guideline (ICH Q6 — Specifications) defines the ICH Q-series quality expectations for specifications & acceptance criteria. 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 specification-justification summary at the action boundary | 1 | 0 | 1 | 0 | 0 | 50% |
| Specification science & acceptance-criteria setting | 1 | 0 | 0 | 0 | 0 | 0% |
Every requirement → the KYE™ artefact that enforces it
| ID | Title | Status | KYE™ enforcement |
|---|---|---|---|
ich-q6.named-authority | AI-generated specification-justification 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-q6.science | Specification science & acceptance-criteria setting | out-of-scope | (no enforcement cited) |
Canonical KYE™ surfaces referenced on this page: KYE Protocol™.