ICH Q8(R2) — Pharmaceutical Development — 75% covered.

4 requirements · 3 enforced · 0 designed · 0 advisory · 0 deferred.

Source: ICH Q8(R2) describes the contents of the pharmaceutical development section (P.2) of a regulatory submission and the principles of Quality by Design — the quality target product profile, critical quality attributes, the design space, and the control strategy. KYE Protocol™ governs whether AI-generated development-report content (a QbD justification, a design-space rationale, a CQA-linkage narrative) may PROCEED to a consequential action — Quality-Unit approval or reliance in a dossier — under a named authority, with the development justification recorded before the action and replay-provable provenance. KYE does not perform the development science, define the design space, or judge whether the justification is scientifically sound. · 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	Coverage
Development-content authority at the action boundary	1	1	100%
Development justification recorded before the action	1	1	100%
Replay-provable development-content provenance	1	1	100%
Development science (QbD / design space / control strategy)	1	0	0%

Every requirement → the KYE™ artefact that enforces it

ID	Title	Status	KYE™ enforcement
`ich-q8.development-justification-provenance`	AI-generated development content proceeds only under a recorded named-authority decision	enforced	audit_events: `kye.purpose.request.v1`, `kye.purpose.admissibility.v1`, `kye.evidence.decision_map.v1` engines: `internal`, `internal` rule_packs: `kye:rule-pack:ich-authority` dictionaries: `internal` constitution_refs: `constitution/12-PURPOSE-PERMISSION.md`
`ich-q8.justification-recorded-before-action`	AI development justification proceeds only with its rationale recorded before the action	enforced	audit_events: `kye.evidence.decision_map.v1`, `kye.evidence.pack.v1` engines: `internal` rule_packs: `kye:rule-pack:ich-authority` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`ich-q8.development-content-provenance`	Replay-provable provenance pin for AI-generated development content relied on in a dossier	enforced	audit_events: `kye.evidence.tool_call.v1`, `kye.replay.context_seal.v1` engines: `internal` rule_packs: `kye:rule-pack:ich-authority` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`ich-q8.development-science`	Defining the QTPP, identifying CQAs and establishing the design space & control strategy	out-of-scope	(no enforcement cited)