GMP項(xiàng)目驗(yàn)證管理和質(zhì)量管理學(xué)習(xí)教案

1、會(huì)計(jì)學(xué)1GMP項(xiàng)目驗(yàn)證管理和質(zhì)量管理項(xiàng)目驗(yàn)證管理和質(zhì)量管理第1頁(yè)/共28頁(yè)P(yáng)Q性能確認(rèn)性能確認(rèn)PQ Test Plan測(cè)試計(jì)劃URS 用戶(hù)需求用戶(hù)需求OQ Test Plan測(cè)試計(jì)劃OQ運(yùn)行確認(rèn)運(yùn)行確認(rèn)IQ安裝確認(rèn)安裝確認(rèn)IQ Test Plan測(cè)試計(jì)劃 Implement執(zhí)行執(zhí)行Detail Design詳細(xì)設(shè)計(jì)詳細(xì)設(shè)計(jì)Function Design 功能設(shè)計(jì)功能設(shè)計(jì)Validation Mode -ISPE “V” Mode常見(jiàn)的驗(yàn)證模式-ISPE “V”型確認(rèn)模式第2頁(yè)/共28頁(yè)用戶(hù)需求需求文件需求鑒別關(guān)鍵系統(tǒng)測(cè)試完工報(bào)告影響因素評(píng)估調(diào)試IOQ項(xiàng)目調(diào)試計(jì)劃完工IOQ報(bào)告確認(rèn)測(cè)試確認(rèn)矩陣設(shè)

2、計(jì)復(fù)核系統(tǒng)接受報(bào)告放行設(shè)計(jì)基礎(chǔ)僅注重產(chǎn)品/工藝/法規(guī)/項(xiàng)目質(zhì)量戰(zhàn)略要求用戶(hù)和其他要求的工程文件（如EHS)各系統(tǒng)應(yīng)有單獨(dú)完工報(bào)告測(cè)試是單一的GEP活動(dòng)包括調(diào)試，SAT/FAT/IOQ確認(rèn)質(zhì)量戰(zhàn)略：基于需求文件的科學(xué)/風(fēng)險(xiǎn)導(dǎo)向流程及設(shè)計(jì)復(fù)核第3頁(yè)/共28頁(yè)URSRequirement DocumentRequirementsIdentification of Critical AspectsTestingClose-out ReportsImpact AssessmentCommissioningIOQPCQPClose-outIOQReportVerification TestingVQS M

3、atrix &Design ReviewSystem Acceptance & release reportDesign BasisFocused on product/process and regulatory/ PQS requirements onlyEngineering Document for user and other requirements (i.e.EHS)Single close-out report for systemTesting is a single GEP activity- covering Commissioning, SAT/FAT/IOQVerification Quality Strategy: Science/Risk based approach based on requirement document and design review第4頁(yè)/共28頁(yè)第5頁(yè)/共28頁(yè)第6頁(yè)/共28頁(yè)第7頁(yè)/共28頁(yè)第8頁(yè)/共28頁(yè)第9頁(yè)/共28頁(yè)第10頁(yè)/共28頁(yè)第11頁(yè)/共28頁(yè)第12頁(yè)/共28頁(yè)第13頁(yè)/共28頁(yè)第14頁(yè)/共28頁(yè)第15頁(yè)/共28頁(yè)第16頁(yè)/共28頁(yè)第17頁(yè)/共28頁(yè)第18頁(yè)/共28頁(yè)第19頁(yè)/共28頁(yè)第20頁(yè)/共28頁(yè)第21頁(yè)/共28頁(yè)第22頁(yè)/共