ICH Q5 — Quality of Biotechnological Products — 25% covered.

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

Source: The Quality of Biotechnological Products guideline (ICH Q5 — Quality of Biotechnological Products) defines the ICH Q-series quality expectations for biotech product quality. 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 biotech-quality summary at the action boundary	1	0	1	0	0	50%
Biotech product science (viral safety / comparability / stability)	1	0	0	0	0	0%

Every requirement → the KYE™ artefact that enforces it

ID	Title	Status	KYE™ enforcement
`ich-q5.named-authority`	AI-generated biotech-quality 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-q5.science`	Biotech product science (viral safety / comparability / stability)	out-of-scope	(no enforcement cited)