risk quality Quality Risk Management.doc

risk quality Quality Risk Management 导读：就爱阅读网友为您分享以下“Quality Risk Management”的资讯，希望对您有所帮助，感谢您对92的支持! WHO guideline – drug Quality Risk Management WHO指南--药品质量风险管理（QRM） Assessment of dossiers- inspection state 档案评估—检查方案 It is a requirement that regulatory inspections cover the QRM process of the organization in question. QRM, along with GMP and quality control (QC), should be considered as a key pillar of what must be a comprehensively designed and correctly implemented system of quality assurance (QA). 管理的检查需要将组织QRM的过程考虑在内，QA系统的正确执行和合理设计应该以QRM 和GMP 及质量控制（QC）作为标杆。 QRM system QRM 系统 All manufacturing authorization holders, developing countries’ manufacturing sites and API manufacturers must have a system for QRM. Inspectors will review the QRM system as part of the quality systems section of the inspection (along with complaints, recalls, deviations, product quality reviews, etc.). Additionally inspectors may review specific risk assessments when encountered during the course of an inspection. Inspectors can allocate time and resources commensurate with their perceived significance of the risk and, only if necessary, request the organization to produce a formal summary of the risk assessment, key decisions and conclusions or take risk-assessment details for further evaluation outside the inspection. Inspectors should be pragmatic regarding the level of scrutiny and degree of formality required for any given situation.