ICH Q1 — Stability Testing — 25% covered.

2 requirements · 0 enforced · 1 designed · 0 advisory · 0 deferred.

Source: The Stability Testing guideline (ICH Q1 — Stability Testing) defines the ICH Q-series quality expectations for stability data. 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 stability summary at the action boundary	1	0	1	0	0	50%
Stability study science & shelf-life determination	1	0	0	0	0	0%

Every requirement → the KYE™ artefact that enforces it

ID	Title	Status	KYE™ enforcement
`ich-q1.named-authority`	AI-generated stability summary proceeds only under a recorded named-authority decision	designed	rule_packs: `kye:rule-pack:ich-authority` dictionaries: `internal` constitution_refs: `constitution/12-PURPOSE-PERMISSION.md`
`ich-q1.science`	Stability study science & shelf-life determination	out-of-scope	(no enforcement cited)