Compliance
ICH Q9
ICH Q9 — Quality Risk Management · q9 · quality risk management
TL;DR
International guideline that mandates risk-based decision-making across the pharma product lifecycle. Underpins everything from supplier qualification to PPQ batch count.
ICH Q9 (revised Q9(R1), Jan 2023) defines the principles and tools of Quality Risk Management — FMEA, HAZOP, FTA, PHA — and how to apply them across development, manufacture, validation, change control, deviation handling and inspection readiness. Embedded in EU GMP Chapter 1 and Annex 20.
V5 supports Q9 by tagging every change-control, deviation and CAPA with risk classification, and by surfacing risk in the work-order release gate.
Regulatory anchors
- ICH Q9(R1)
- EU GMP Chapter 1
Industries that live with this
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