---
title: "ICH Q3 — Impurities — KYE Protocol™ coverage"
description: "ICH Q3 — Impurities coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it."
url: https://kyeprotocol.com/compliance/ich-q3/
lang: en
source: "KYE Protocol"
---

> ICH Q3 — Impurities coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.

ICH Q3 — Impurities

# ICH Q3 — Impurities — 50% of in-scope requirements covered.

2 requirements · 1 in scope (1 designed) · 1 out-of-scope (outside KYE™’s authority layer). The 50% is weighted over the in-scope base.

**Source:** The Impurities guideline (ICH Q3 — Impurities) defines the ICH Q-series quality expectations for impurity thresholds. 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 impurity-assessment summary at the action boundary | 1 | 0 | 1 | 0 | 0 | **50%** |
| Impurity science & threshold determination | 1 | 0 | 0 | 0 | 0 | **0%** |

## Every requirement → the KYE™ artefact that enforces it

| ID | Title | Status | KYE™ enforcement |
| --- | --- | --- | --- |
| `ich-q3.named-authority` | AI-generated impurity-assessment 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-q3.science` | Impurity science & threshold determination | out-of-scope | _(no enforcement cited)_ |

Canonical KYE™ surfaces referenced on this page: [KYE Protocol™](https://kyeprotocol.com/).