ＩNＴEＲNAＴIONAL CONFERＥＮCE ＯN HARＭOＮISATＩＯＮ OＦ TECHNICAL REQＵIRＥＭEＮTＳ FＯR REGISTRATＩON OＦ ＰHAＲMACＥＵTICAＬS FＯR HＵMAN USE人用药注册技术规定国际协调会议ICH Harｍoniｓed Tｒipａrｔitｅ Guｉｄｅlinｅ人用药注册技术规定国际协调会议三方协调后的指南Quaｌity Ｒｉsｋ Managｅｍenｔ质量风险管理Cｕrrenｔ Sｔｅp 4 version现行第四步版本dated ９ Noｖeｍbeｒ 年十一月 9日This Ｇuideｌine ｈaｓ been developeｄ bｙ the ａｐprｏpｒiate IＣH Exｐeｒt Wｏrking Group anｄ haｓ ｂeen subject ｔo cｏnｓulｔａｔｉon by the regulａtory ｐａｒtieｓ, ｉn aｃcｏrdａｎce ｗiｔh ｔhｅ ICH Pｒocess. At Sｔep 4 ｏf ｔhe Pｒocｅss ｔhe finａl ｄｒaft iｓ ｒecomｍended for adoｐtｉon to tｈe regｕlatory bodies of the Eｕrｏpeａn Ｕnｉon， Japａn and USＡ.本指南由人用药注册技术规定国际协调会议专家工作组根据人用药注册技术规定国际协调会议程序开发并提交各方的药政部门征询。
根据人用药注册技术规定国际协调会议程序第四步，推荐给欧盟、日本和美国药的政部门采用的最后文本Ｄocument Ｈistｏrｙ文献历史Coｄification最初编码Hｉsｔoｒy历史Appｒovaｌ by thｅ Sｔeｅriｎg Commitｔee undｅｒ Step 2 and ｒｅｌease for ｐｕbｌic conｓultatｉon.指引委员会批准第二步文献并发放用于公开征询Dａte日期Q922 Ｍarcｈ / 3 /22Approｖａl bｙ ｔhe Steering Commitｔｅｅ ｏf Post Step ２ ｃorrｅcｔion指引委员会在批准第二步后的订正文献15 Juｎｅ / ６ / 1５Cuｒｒent Stｅp ４ verｓion现行第四步版本Apprｏvａl by ｔｈｅ Steeｒinｇ Cｏmmｉttee under Ｓteｐ 4 and recｏmmendaｔion fｏr adoptｉoｎ ｔｏ ｔhe ｔhｒee IＣH regｕｌatoｒy ｂodieｓ．指引委员会批准第四步文献并推荐 ICH 三方药政部门批准９ Noｖember / １１ / 9Ｈaving reacｈｅd Stｅp ４ of tｈe ICH Pｒocess at the ICＨ Sｔeｅrｉng Committｅe meetiｎｇ oｎ 9 Novｅｍｂer , ｔhis guiｄeline is ｒeｃoｍｍenｄeｄ ｆor ａdｏｐtion to the three reｇuｌａtory ｐａrties ｔｏ ICH在 年 １1 月 9 日的人用药注册技术规定国际协调会议上,本指南已经通过人用药注册技术规定国际协调会议第四步程序,本指南已经推荐给人用药注册技术规定国际协调会议三方的药政部门采用。
ﻬTＡBLE ＯＦ ＣONTENTS目录1． INＴRＯDＵＣTION 简介.....．.....．..．.．...．.............．......．........．．..............．．．...．....．．.12. ＳCＯＰE 范畴..．....．............．........．...．...．.．.......．．.．...．..．...．......．...．...２3. ＰＲIＮCIPLＥS ＯF QUALＩTY ＲISＫ MＡNAＧＥMENT 质量风险管理的原则...．..．....．24. GENERAL QＵALITY RISK MAＮAＧＥMＥＮＴ PＲOCＥSS 常规质量风险管理程序..．..24.1 Ｒespｏnsiｂilｉtｉes 职责．．.．.．．...．．.．.........．..．.．..．...．....．..．......．.．．..．．..．．....．．..．．..．.．.．...．..44.2 Iniｔiaｔｉng a Quａlitｙ Risk Ｍaｎagｅment Process 启动质量风险管理过程．..．...44.３ Risk Aｓsessmｅnt 风险评估....．..．.．..．..．.........．.．..．.....．.....．......．．........．．......44．４ Ｒｉsk Cｏntrｏl风险控制．.．.．..．．..．..．.．...．........．.．．............．.......．....．.......．.54.5 Riｓk Ｃommｕnｉcatiｏn风险沟通...．.．.．.........．．.．．．..．.．...．.．...．...．.．..．..．.．..．．....．....．..．6４．6 Riｓｋ Revｉew 风险评审......．.....．.．.．..．.....．．...．......．..．............．.......．...．65． RISK MANAGEMEＮT ＭETＨOＤOＬOGY 风险管理措施学 ．.................．.．...．．.．．......76. INTEＧRＡＴION OF QＵＡLITＹ RISＫ MANＡGＥMEＮT INTO INDUSTRY AND REGULATORY OPERATＩONS质量风险管理与业界及药政运营整合.．．....．..．．.．...．.．....．...．...．..．．..．...．．...．．８7. DEFＩNITIOＮＳ 定义..．...．.......．...．...．........．.........．...．．........．....．.........．..98. RＥFERENCＥS 参照文献．.．...．.．...．．....．.．．...．......．....．...........．........．.．.．.．11Annｅx 附录 I: Riｓk Managｅmｅｎt Methｏdｓ ａnd Tｏols风险管理措施与工具... 12Ｉ.１ Basiｃ Rｉsk Maｎageｍenｔ Facilitaｔion Methｏds基本风险管理简易措施 ．．....． 12I.2 Ｆaiｌure Mｏdｅ Ｅｆfectｓ Aｎaｌysis故障模式效应分析(FMEA）......．.．..．．..．....．.....１2I.3 Ｆaiｌuｒｅ Moｄe， Ｅfｆects aｎd Criticaｌiｔy Anaｌyｓis 故障模式影响与严重性分析（ＦMECA).．......．......．...．.．......．..．.．.......．．..．.．....13I．4 Fauｌt Trｅｅ Analｙsiｓ 故障树分析（ＦTA）.....．........．．.．..．.．..．.．．...．....．．.13I．5 Hazard Analysｉs anｄ Critｉcａl Conｔｒol Poｉntｓ危害分析核心控制点(ＨＡCCＰ）．..．..．....．.......．．．....．.．．.．...．.．........．．．....．..．....．...．.．14I.6 Hazaｒd Opｅrabilitｙ Aｎalｙsis 危害及可操作性分析(ＨAZＯP)...．....．．.．．..．..１4I.7 Preliminary Hazａｒd Analysis 预先危险分析(ＰHＡ）．．...．.．........．......．...．．.．....15I.8 Rｉsk Rａnking and Ｆiｌｔerinｇ风险排序及过滤 ..．．.......．.．..．．．...．．15I.9 Suｐpoｒtiｎｇ Statisｔｉcaｌ Tｏｏls辅助性记录工具...．．.．...........．...．..．........．．.．......1６Aｎｎex 附录 II: Poteｎtial Appｌicaｔｉｏns ｆｏr Qualitｙ Rｉｓk Ｍanagemｅnt 实行质量风险管理的潜在机会．....．.．.....．....．．..．．...........．．．.16ＩI.1 Qｕａｌiｔy Rｉｓk Manａｇｅｍeｎｔ as Pａrt oｆ Integratｅd Ｑuａｌity Managemeｎt 整合质量管理部分的质量风险管理......．...．..．..．...1６IＩ．2 Qualｉｔy Rｉsｋ Manaｇement ａs Part of Reｇuｌａtory Oｐeratiｏns 药政操作部分的质量风险管理.．..．.．.........．.....．..．.．.．...．．........1８II.3 Ｑualitｙ Ｒｉsk Manaｇement ａs Part ｏf deveｌoｐmｅnｔ 开发部分的质量风险管理 ．...．........．..．......．.．.．..．....................．．．.....．..．..．1９IＩ.４ Qualｉty Risk Maｎａgeｍｅｎｔ foｒ Facｉliｔｉeｓ， Eｑuipｍent aｎd Ｕtilｉtieｓ 厂房，设备和公用设施的质量风险管理 ...．......．.．.....1９II.5 Quａｌity Rｉsk Manａｇement ａs Ｐart of Maｔerｉals Managemenｔ 物料管理部分的质量风险管理....．．..........．.....．..．．．．....．.．......21II．６ Ｑualｉty Riｓk Management as Part of Pｒoducｔioｎ 生产部分的质量风险管理.......．..........．．.．.......．．..．．......．.．......．........．．........．２1II.7 Qｕalｉty Rｉsk Manａｇemｅｎt aｓ Paｒｔ ｏf Labｏratory Control aｎd Stａbility Ｓtuｄｉes 实验室控制和稳定性研究部分的质量Qualｉty Risk Managemｅnt质量风险管理风险管理....．．.....．.....．.........．...．....22ＩI．8 Quality Ｒisk Ｍanａgｅment ａs Pａｒt of Paｃkagｉng aｎｄ Ｌabeｌling 包装和标签部分的质量风险管理...．..．..．．．...．.．．....．...．......．2２ﻬ１. ＩＮＴRODUＣTＩON 导言Risｋ manaｇｅment ｐrincｉplｅs are effecｔivｅly utiｌｉzeｄ in many arｅas of bｕｓinesｓ anｄ goveｒnmeｎt inclｕding financｅ， ｉnｓuranｃｅ， ｏｃｃupatｉoｎaｌ safeｔｙ, public health。