ICH Q6 — Specifications · vICH Q6A/Q6B

ICH Q6 — Specifications

ICH Q6 — Specifications — 25% covered.

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

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

CategoryReqsEnforcedDesignedAdvisoryDeferredCoverage
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

IDTitleStatusKYE 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-authority
dictionaries: internal
constitution_refs: constitution/12-PURPOSE-PERMISSION.md
ich-q6.science Specification science & acceptance-criteria setting out-of-scope (no enforcement cited)