ICH Q8(R2) — Pharmaceutical Development

ICH Q8(R2) — Pharmaceutical Development — 100% of in-scope requirements covered.

4 requirements · 3 in scope (3 enforced) · 1 out-of-scope (outside KYE™’s authority layer). The 100% is weighted over the in-scope base.

ICH Q8(R2): requirement → the KYE™ artefact that enforces it

Demo data

You learn: Which requirements KYE™ enforces at runtime and with which artefact. You can: Walk the requirements.

  1. development-justification-provenance · enforced

    AI-generated development content proceeds only under a recorded named-authority decision

    Audit events: kye.purpose.request.v1, kye.purpose.admissibility.v1, kye.evidence.decision_map.v1 · Rule packs: kye:rule-pack:ich-authority · Constitution: 12 purpose permission

  2. justification-recorded-before-action · enforced

    AI development justification proceeds only with its rationale recorded before the action

    Audit events: kye.evidence.decision_map.v1, kye.evidence.pack.v1 · Rule packs: kye:rule-pack:ich-authority · Constitution: 13 resilience loop

  3. development-content-provenance · enforced

    Replay-provable provenance pin for AI-generated development content relied on in a dossier

    Audit events: kye.evidence.tool_call.v1, kye.replay.context_seal.v1 · Rule packs: kye:rule-pack:ich-authority · Constitution: 13 resilience loop

  4. development-science · out-of-scope

    Defining the QTPP, identifying CQAs and establishing the design space & control strategy

    (no enforcement cited)

How this widget is built
Demonstrates
KYE™ Compliance Mapping Rail™
Components
  • Framework requirement (clause)
  • Coverage status
  • KYE™ enforcement artefact (event, decision-record field, Evidence Pack™ entry)
Flow
Clause → status → the KYE™ artefact that enforces it, enforced requirements first. Architecture diagram
Used on

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

CategoryReqsEnforcedDesignedAdvisoryDeferredCoverage
Development-content authority at the action boundary11000100%
Development justification recorded before the action11000100%
Replay-provable development-content provenance11000100%
Development science (QbD / design space / control strategy)100000%

Every requirement → the KYE™ artefact that enforces it

IDTitleStatusKYE™ enforcement
ich-q8.development-justification-provenanceAI-generated development content proceeds only under a recorded named-authority decisionenforcedaudit_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-actionAI development justification proceeds only with its rationale recorded before the actionenforcedaudit_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-provenanceReplay-provable provenance pin for AI-generated development content relied on in a dossierenforcedaudit_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-scienceDefining the QTPP, identifying CQAs and establishing the design space & control strategyout-of-scope(no enforcement cited)

Canonical KYE™ surfaces referenced on this page: Decision Rationale · KYE Protocol™.