ICH Q7 — Good Manufacturing Practice for Active Pharmaceutical Ingredients
ICH Q7 — Good Manufacturing Practice for Active Pharmaceutical Ingredients — 100% of in-scope requirements covered.
5 requirements · 4 in scope (4 enforced) · 1 out-of-scope (outside KYE™’s authority layer). The 100% is weighted over the in-scope base.
Source: ICH Q7 provides guidance on Good Manufacturing Practice for the manufacturing of Active Pharmaceutical Ingredients (APIs), covering quality management and the independent Quality Unit, records and data integrity, batch production and release, and the responsibilities for releasing or rejecting APIs. KYE Protocol™ governs whether an AI-generated GMP record (a batch record entry, a deviation, a release recommendation) may PROCEED to a consequential action — Quality-Unit approval, lot release, or use in a dossier — under a named Quality Unit / QP authority, with a data-integrity / ALCOA+ screen recorded before the action and replay-provable provenance, with §36 two-person sign-off on the irreversible lot release. KYE™ does not manufacture the API, run the analysis, or judge whether the batch meets specification. · 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 |
|---|---|---|---|---|---|---|
| Quality-Unit release authority at the action boundary | 1 | 1 | 0 | 0 | 0 | 100% |
| Records & data integrity (ALCOA+) screened before the action | 1 | 1 | 0 | 0 | 0 | 100% |
| Replay-provable GMP-record provenance | 1 | 1 | 0 | 0 | 0 | 100% |
| Batch release sign-off gate (§36 two-person) | 1 | 1 | 0 | 0 | 0 | 100% |
| Physical API manufacture & analytical testing | 1 | 0 | 0 | 0 | 0 | 0% |
Every requirement → the KYE™ artefact that enforces it
| ID | Title | Status | KYE™ enforcement |
|---|---|---|---|
ich-q7.quality-unit-batch-release | AI-generated GMP record proceeds only under a recorded Quality-Unit / QP named-authority decision | enforced | audit_events: kye.purpose.request.v1, kye.purpose.admissibility.v1, kye.evidence.decision_map.v1engines: internal, internalrule_packs: kye:rule-pack:ich-authoritydictionaries: internalconstitution_refs: constitution/12-PURPOSE-PERMISSION.md |
ich-q7.data-integrity-alcoa | Data-integrity / ALCOA+ screen of the GMP data behind an AI record recorded before the action | enforced | audit_events: kye.evidence.tool_call.v1, kye.evidence.decision_map.v1engines: internal, internalrule_packs: kye:rule-pack:ich-authorityconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
ich-q7.gmp-record-provenance | Replay-provable provenance pin for an AI-generated GMP record relied on in a consequential action | enforced | audit_events: kye.evidence.tool_call.v1, kye.replay.context_seal.v1, kye.evidence.pack.v1engines: internalrule_packs: kye:rule-pack:ich-authorityconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
ich-q7.batch-release-signoff | Lot release stays advisory until §36 two-person Quality-Unit / QP sign-off is recorded (irreversible release) | enforced | audit_events: kye.evidence.decision_map.v1, kye.evidence.pack.v1engines: internalrule_packs: kye:rule-pack:ich-authorityconstitution_refs: constitution/36-GOVERNEDUI.md |
ich-q7.physical-api-manufacture | Physical API manufacture, process control and analytical testing | out-of-scope | (no enforcement cited) |
Canonical KYE™ surfaces referenced on this page: KYE Protocol™.