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Valid from 23.10.2026

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In most countries compliance with good manufacturing practices (GMP), medicines regulatory activities and inspections, together with supply chain controls throughout the product life-cycle, provide good assurance that risks are largely controlled. However, where control is less effective, patients may be put at risk through the production of medicines of inadequate quality. Quality risk management (QRM) is a process that is relevant to all countries and should provide a rationale to understand risk and mitigate it through appropriate and robust controls. To protect patients in terms of quality, safety and efficacy of medicines, international medicines regulatory authorities (MRAs) are recommending pharmaceutical manufacturers to adopt a risk-based approach to the life-cycle of a pharmaceutical product. QRM is the overall and continuing process of appropriately managing risks to product quality  throughout the product's life-cycle in order to optimize its benefit–risk balance. It is a systematic process for the assessment, control, communication and review of risks to the quality of the pharmaceutical product. It can be applied both proactively and retrospectively.