Compliance
ICH Q10
ICH Q10 — Pharmaceutical Quality System · q10 · pqs
TL;DR
The international model for a Pharmaceutical Quality System covering the entire product lifecycle from development to discontinuation.
ICH Q10 describes the Pharmaceutical Quality System: management responsibility, design and content elements (process performance & product quality monitoring, CAPA, change management, management review), continual improvement, and lifecycle stages. Adopted into EU GMP Chapter 1.
V5 covers the operational pillars: CAPA, change management, management review (dashboards), process-performance monitoring (CPV / SPC).
Regulatory anchors
- ICH Q10
- EU GMP Chapter 1
Industries that live with this
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