ICH Q9 Quality risk management - Scientific guideline

This document provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products.

Keywords: Risk assessment, quality risk management, risk, harm, hazard, failure mode and effects analysis (FMEA)

Current version - effective from 26/07/2023

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q9 (R1) on quality risk management - Step 5 - Revision 2

Adopted Reference Number: EMA/CHMP/ICH/24235/2006 Corr.2

Document history

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q9 (R1) on quality risk management - Step 5 - Revision 1

Adopted Reference Number: EMA/CHMP/ICH/24235/2006 Legal effective date: 26/07/2023

Draft International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q9 (R1) on quality risk management - Step 2b

Draft: consultation closed Consultation dates: 16/12/2021 to 15/03/2022 Reference Number: EMA/CHMP/ICH/24235/2006 Summary:

Comments should be provided using this template. The completed comments form should be sent to [e-mail]

Overview of comments received on ICH guideline Q9 (R1) on quality risk management (EMA/CHMP/ICH/24235/2006)

Reference Number: EMA/158487/2022

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q9 on quality risk management - Step 5 - First version

Adopted Reference Number: EMA/CHMP/ICH/24235/2006