SIA Report-OSD-樣表資料文檔

SystemImpactAssessmentReportforOralSolidDosagePlant口服固體制劑車間系統(tǒng)影響評估報告ReportApproval報告批準Company/Title公司/職務(wù)Name姓名Signature簽名Date日期Writtenby編寫Reviewedby審核Approvedby批準RevisionHistory版本修訂索引Rev.版本Date日期RevisionReasons修訂原因00InitialIssue首次頒布第2頁，共8頁1.Purpose目的2.Scope范S33.Conclusions結(jié)論4.Appendix附表Index目錄第3頁，共8頁Purpose目的ThisdocumentsummarizestheactivitiesofSystemImpactAssessment(SIA)fortheOralDosagePlantoftheXXX.TheSystemImpactAssessmentisusedtoassesstheimpactsofequipmentandutilitiesonproducts.SystemsorequipmenthavingdirectimpactonproductqualityaresubjecttoqualificationinadditiontobeingdesignedunderGoodEngineeringPractices(GEP).Systemsdesignatedas“IndirectImpacfand“NoImpacfaresubjecttoGEPrequirementsfordesign,installationandcommissioning.本文件對位于XXX口服制劑車間的系統(tǒng)影響評估活動進行了總結(jié)。系統(tǒng)影響評估過程評估了設(shè)備和公用工程對于產(chǎn)品的影響。對產(chǎn)品質(zhì)量有直接影響的系統(tǒng)或設(shè)備除根據(jù)良好的工程管理規(guī)范(GEP)設(shè)計外，還需要進行確認。對“間接影響”和“無影響”的系統(tǒng)，需要根據(jù)良好的工程管理規(guī)范設(shè)計、安裝和調(diào)試。Thescopeofworkincludestheassessmentofequipment(includingautomationequipment),utilitiesandsystems(collectivelyreferredtoasSystem)relatedtotheOralDosagePlant.本活動適用于評估所有與口服制劑車間相關(guān)的設(shè)備(包括自控設(shè)備)、公用工程和系統(tǒng)(統(tǒng)稱為“系統(tǒng)”)O2.Conclusions結(jié)論TheSystemImpactAssessment(SIA)wasperformedasdescribedinthedocument.ThisSIAwasperformedbyateamconsistingofengineersfromXXXfromJuly6,20xxandJuly15,20xx.ThecompletedformsareappendedinAppendix1.系統(tǒng)影響評估遵循文件的描述。影響評估由包括XXX工程師的團隊來執(zhí)行，執(zhí)行時間是20XX年7月6日到20XX年7月15日。完成的表格附在附錄1.SystemboundariesaredefinedfortheequipmentandsystemsoftheOralDosagePlantontherelevantP&IDs.ThesesystemboundariesdefinitionresultsweredocumentedintheSystemImpactAssessmentSummaryForm(seeAppendix1).Theimpactofasystemisassessedbasedonitsinfluencestothesafety,properties,strength,purity,efficacyorqualityoftheproduct.Thesystemimpactassessmentprocessisdescribedinthedocument.Ithasbeenusedasasimpleassessmenttooltomakeayes/nodeterminationastowhetherthesystemmayimpactproductquality.口服制劑車間的設(shè)備和系統(tǒng)，在P&ID圖上進行了系統(tǒng)劃分。系統(tǒng)劃分結(jié)果記錄在系統(tǒng)匯總表中(見附表1)。通過對產(chǎn)品的安全性、特性、效價、純度、有效性、或質(zhì)量對系統(tǒng)進行影響評估。文件中對影響評估過程進行了描述，它作為一個簡單的評估工具，通過問答是或否來確定系統(tǒng)是否影響產(chǎn)品的質(zhì)量。Itshouldbenotedthatifthedetaileddesignchangesfollowingtheassessment,thesystemsand第4頁，共8頁componentsmustbere-evaluatedforthesystemimpactassessmentinordertoensurethatsystemspreviouslyjudgedtobeIndirectImpactorNoImpacthavenotacquiredacriticalfunction.應(yīng)注意，如果在評估之后詳細設(shè)計發(fā)生了變更，必須重新對系統(tǒng)和部件進行系統(tǒng)影響性評估，以保證之前被判定為間接影響或無影響的系統(tǒng)沒有新獲得任何關(guān)鍵功能。Thesystemsweredefinedasbeing'DIRECT1,INDIRECT,or'NOIMPACT.ThisissummarizedinTables1,2and3andTable4fortheautomationsystem.系統(tǒng)劃分為“直接”“間接”“無影響”，總結(jié)在表格1、2、3和自控系統(tǒng)的表格4中。第5頁，共8頁

TABLE1:'DIRECTIMPACTSYSTEMS表1：直接影響系統(tǒng)Item序號Area區(qū)域NumberofSystem系統(tǒng)數(shù)量1.OralDosagePlant口服制劑車間262TABLE2:INDIRECTIMPACT'SYSTEMS表2：間接影響系統(tǒng)Item序號Area區(qū)域NumberofSystem系統(tǒng)數(shù)量1.OralDosagePlant口服制劑車間11TABLE3:'NOIMPACT'SYSTEMS表3：無影響系統(tǒng)Item序號Area區(qū)域NumberofSystem系統(tǒng)數(shù)量1.OralDosagePlant口服制劑車間83第6頁，共8頁

TABLE4:AUTOMATEDSYSTEMS表4：自控系統(tǒng)Item序號SystemName系統(tǒng)名稱NumberofSystem系統(tǒng)數(shù)量DirectImpact直接影響1.HVACAutomationS