What ICH Q9(R1) Quality Risk Management - Risk Assessment, Risk Control and Risk Communication in Pharmaceutical Manufacturing requires
ICH Q9(R1) Quality Risk Management is the revised version of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q9 guideline, reached Step 4 of the ICH process on 18 January 2023 and entered into force on 26 July 2023 in the EU (EMA/CHMP/ICH/24235/2006 R1), 30 May 2023 in Japan, and similar timeline in US FDA. ICH Q9(R1) provides a systematic approach to Quality Risk Management (QRM) applicable to the pharmaceutical lifecycle including pharmaceutical development, manufacturing, distribution, inspection, and submission/review processes. The Guideline articulates two primary principles: (1) the evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient; and (2) the level of effort, formality and documentation of the QRM process should be commensurate with the level of risk. The QRM process is structured as: Risk Assessment (identification, analysis, evaluation), Risk Control (reduction, acceptance), Risk Communication, and Risk Review. The R1 revision strengthens guidance on (a) high levels of subjectivity in risk assessments, (b) management of supply chain risks, (c) ensuring availability of medicinal products, and (d) formality in QRM activities scaled to risk level. Common QRM tools include FMEA (Failure Mode and Effects Analysis), HACCP (Hazard Analysis and Critical Control Points), and FTA (Fault Tree Analysis).
Pillar: Pharmaceuticals & Life Sciences · Authority: International Council for Harmonisation (ICH) Assembly; ICH Q9 Expert Working Group; implemented by ICH Founding Regulators (EMA Europe, FDA United States, MHLW/PMDA Japan, Health Canada, Swissmedic) and ICH Members and Observers globally · Version: 1.0.0 · Last updated:
Primary source: https://www.ema.europa.eu/en/ich-q9-quality-risk-management-scientific-guideline
SHA-256 integrity: 3b7b9e9caeb5ddb3e7629d2ec7f826b25f3a42cca0cb1d2451e63753b145c391
Primary Citations — 7 traced to source
- ICH Harmonised Guideline Quality Risk Management Q9(R1), reached Step 4 of ICH process on 18 January 2023 and adopted by ICH Assembly - revised version of Q9 originally adopted November 2005; provides systematic approach to QRM across pharmaceutical lifecycle
- ICH Q10 Pharmaceutical Quality System, reached Step 4 on 4 June 2008 - comprehensive model for pharmaceutical quality system that integrates with QRM under Q9; covers product realisation, control strategy, continual improvement, knowledge management
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