ICH Q9 Quality risk management - Scientific guideline
Table of contents
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)
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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 (PDF/444.91 KB)
Adopted
First published: 06/02/2023
Legal effective date: 26/07/2023
EMA/CHMP/ICH/24235/2006 -
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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 (PDF/706.71 KB)
Draft: consultation closed
First published: 16/12/2021
Consultation dates: 16/12/2021 to 15/03/2022
EMA/CHMP/ICH/24235/2006 -
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Overview of comments received on ICH guideline Q9 (R1) on quality risk management (EMA/CHMP/ICH/24235/2006) (PDF/420.33 KB)
First published: 20/04/2022
EMA/158487/2022 -
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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 (PDF/330.64 KB)
Adopted
First published: 19/01/2006
Last updated: 28/05/2014
EMA/CHMP/ICH/24235/2006
- ICH: quality
- Quality: manufacturing
- Quality: pharmaceutical development
- Quality: Quality by Design (QbD)
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European Medicines Agency-Food and Drug Administration pilot programme for parallel assessment of quality-by-design applications: lessons learnt and questions and answers resulting from the first parallel assessment
- ICH-endorsed guide for ICH Q8/Q9/Q10 implementation
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Questions and answers on design-space verification
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Questions and answers on level of detail in the regulatory submissions
- Training material for Q8/Q9/Q10
- ICH Q8 (R2) Pharmaceutical development
- ICH Q10 Pharmaceutical quality system
- Need for a reflection paper on quality aspects of medicines for older people
- Pharmaceutical development of medicines for paediatric use
- Questions and answers on implementing the ICH guidelines Q8, Q9 and Q10
- Real time release testing
- Use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations
- ICH Q9 Briefing Pack and Training Programme for Q8, Q9 and Q10 (see Q9 Briefing Pack and ICH Q8/Q9/Q10 Training Material under ICH Q9 Pharmaceutical risk management: WG Presentations / Trainings)