What ICH Harmonised Guideline Q9(R1) Quality Risk Management requires
This guideline requires pharmaceutical manufacturers to implement a systematic, science-based Quality Risk Management (QRM) process throughout the product lifecycle to ensure patient safety and product quality. As mandated by Section 3, QRM principles must be integrated into existing quality systems to support risk-based decision-making.
Pillar: Medical & Healthcare · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) · Version: 1.0.0 · Last updated:
Primary source: https://database.ich.org/sites/default/files/ICH_Q9%28R1%29_Guideline_Step4_2023_0126.pdf
SHA-256 integrity: b1bc2b9e3db5739f4939c066d580eacabc608b2713a0b9f21edc67a8c40b4485
Primary Citations — 6 traced to source
- ICH Q9(R1), Section 3: Principles of Quality Risk Management
- ICH Q9(R1), Section 4: General Quality Risk Management Process
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