WHO 发布质量风险管理指南草案并公开征求意见

The WHO has published draft guidelines to help organisations develop and implement effective quality risk management (QRM) throughout a medicine's lifecycle from research and development and sourcing of materials to manufacturing, testing, storage and distribution. The aim is to support proactive, well-informed decisions that identify and mitigate risks to product quality, and ultimately protect patients. It is organised into six main sections: Introduction, scope and principles: Explains the purpose of QRM and its application from research and development through manufacturing, testing, storage, distribution and regulatory oversight. It emphasizes that decisions should be science-based and focused on protecting patients, with the effort and documentation proportionate to the level of risk. Glossary: Defines key QRM terms. The QRM process: Covers how to initiate a risk assessment; involve appropriate personnel; use product and process knowledge; assess, control and review risks; verify the process; and document and communicate decisions. It also discusses reducing subjectivity and making risk-based decisions. QRM in pharmaceutical companies: Describes QRM in staff training, assignment of responsibilities, product development, validation and qualification, commercial manufacturing, and quality-system activities. QRM for regulatory authorities: Addresses risk-based inspection planning and conduct, CAPA and complaint review, assessing a manufacturer's QRM system, and applying QRM to dossier review. Risk management tools: Introduces tools including Preliminary Hazard Analysis and statistical methods. The draft is open for public comment until 15 November 2026.