ICH Q10 — Pharmaceutical Quality System

ICH Q10 — Pharmaceutical Quality System — 88% of in-scope requirements covered.

5 requirements · 4 in scope (3 enforced · 1 designed) · 1 out-of-scope (outside KYE™’s authority layer). The 88% is weighted over the in-scope base.

Source: ICH Q10 describes a model for an effective Pharmaceutical Quality System (PQS) based on ISO quality concepts, incorporating applicable GMP and supporting ICH Q8 and Q9. It covers management responsibility, the four PQS elements (process performance & product quality monitoring, CAPA, change management, management review), and knowledge management across the lifecycle. KYE Protocol™ governs whether an AI-generated PQS record (a CAPA record, a change-control record, a management-review input, a deviation disposition) may PROCEED to a consequential action under a named management / Quality Unit authority, with competence and justification recorded before the action and replay-provable provenance. KYE™ does not run the quality system, perform the CAPA investigation, or judge whether the disposition is correct. · 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	Coverage
Management responsibility & named-authority	1	1	0	100%
Change-management authority at the action boundary	1	1	0	100%
Management review control (sign-off gate)	1	1	0	100%
Personnel competence recorded before the action	1	0	1	50%
Quality-system substance (CAPA / change science)	1	0	0	0%

Every requirement → the KYE™ artefact that enforces it

ID	Title	Status	KYE™ enforcement
`ich-q10.management-responsibility-authority`	AI-generated PQS record proceeds only under a recorded named-management / Quality-Unit 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-q10.change-management-authority`	AI-generated change-control record proceeds only with recorded authority + justification before the change	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-q10.management-review-control`	AI-generated PQS output stays advisory until a named reviewer records sign-off (management review control)	enforced	audit_events: `kye.evidence.decision_map.v1`, `kye.evidence.pack.v1` engines: `internal` rule_packs: `kye:rule-pack:ich-authority` constitution_refs: `constitution/36-GOVERNEDUI.md`
`ich-q10.personnel-competence`	AI agent competence for the quality task recorded before the action (personnel competence)	designed	rule_packs: `kye:rule-pack:ich-authority` dictionaries: `internal` constitution_refs: `constitution/12-PURPOSE-PERMISSION.md`
`ich-q10.quality-system-substance`	CAPA investigation, change impact assessment and product-quality monitoring science	out-of-scope	(no enforcement cited)

Canonical KYE™ surfaces referenced on this page: KYE Protocol™.