數(shù)據(jù)完整性和計(jì)算機(jī)管理GMP要求課件

數(shù)據(jù)完整性和計(jì)算機(jī)管理GMP要求..服從真理，就能征服一切事物數(shù)據(jù)完整性和計(jì)算機(jī)管理GMP要求內(nèi)容口FDA對數(shù)據(jù)完整性要求口MHRA(英國藥監(jiān)機(jī)構(gòu))數(shù)據(jù)完整性指南要求口計(jì)算機(jī)管理要求FDA數(shù)據(jù)完整性要求DataIntegrityFDA檢查發(fā)現(xiàn)WhatFDAObservedduringInspections數(shù)據(jù)完整性問題DataIntegrityIssues(1)FDA檢查發(fā)現(xiàn)事實(shí)FDAObservedFacts口未及時記錄Notrecordingactivitiescontemporaneously口倒簽日期Backdating口沒有原始記錄或記錄造假Norawdataand/orfabricatingdata口復(fù)制歷史數(shù)據(jù)作為新數(shù)據(jù)Copyingexistingdataasnewdata口重復(fù)進(jìn)樣和預(yù)檢測Re-runningsamplesandpre-testing口丟棄數(shù)據(jù)(無效數(shù)據(jù)未說明)Discardingdata((invaliddatawithoutjustification)數(shù)據(jù)完整性問題DataIntegrityIssues(2)口沒有原始數(shù)據(jù)Norawdatafor:√標(biāo)準(zhǔn)品配制Standardpreparation√樣品稱重Sampleweights√樣品溶液準(zhǔn)備和樣品稀釋Samplesolutionpreparationandsampledilutions沒有這些信息,無法計(jì)算結(jié)果Withoutthisinformation,assayscannotbecalculated數(shù)據(jù)完整性問題DataIntegrityIssues(3)分析方法沒有很好執(zhí)行AnalyticalMethodsarenotwell-definedandfollowed>調(diào)整HPLc的積分參數(shù)ChangeHPLCintegrationparameters重新進(jìn)樣直到結(jié)果符合Re-runsamplesuntilpassingresultsobtained重新計(jì)算直到結(jié)果符合Re-calculateuntilacceptableresultsobtained測試時間和記錄報(bào)告不匹配Timeusedforcompletethetestsnotaddedupwiththetimepurportedintherecords審計(jì)追蹤功能沒有啟用或沒有審核Audittrailfunctionwasdisabledornotreviewed數(shù)據(jù)完整性問題DataIntegrityIssues(4)口Qc實(shí)驗(yàn)室數(shù)據(jù)QualityControlData√某批次的結(jié)果數(shù)據(jù)應(yīng)用于其他批次的放行Testresultsfromonebatchwereusedtoreleaseotherbatches電子版本與打印版本不一致Discrepanciesbetweenelectronicandprintedversions數(shù)據(jù)完整性問題DataIntegrityIssues(4)口Qc實(shí)驗(yàn)室數(shù)據(jù)QualityControlData轉(zhuǎn)抄數(shù)據(jù)(從小紙片上轉(zhuǎn)抄到實(shí)驗(yàn)室記錄本中)Transcribingdata(fromsmallpiecesofpaperontoanalyticalworksheets)首次記錄的數(shù)據(jù)為原始數(shù)據(jù)Thefirstrecordeddataisconsideredastheoriginalrawdata因此丟棄了原始數(shù)據(jù)Therefore,discardingthe"originalrawdata"增加了轉(zhuǎn)抄的風(fēng)險ncreasetheriskoftranscriptionerrors轉(zhuǎn)抄錯誤從不會發(fā)現(xiàn)并組織調(diào)查Transcriptionerrorswouldneverbedetectedintheeventofinvestigation同樣數(shù)據(jù)先用鉛筆填寫,隨后抹去,然后進(jìn)入使用永久性墨水稍后提供虛假印象按時記錄。數(shù)據(jù)完整性問題DataIntegrityIssues(5)口Qc實(shí)驗(yàn)室數(shù)據(jù)QualityControlData在系統(tǒng)適應(yīng)性運(yùn)行前預(yù)檢測Pre-testingsamplesbeforesystemsuitabilityruns非正式樣品使用不同的名字,例如“測試/小試、演示、培訓(xùn)等”Unofficialtestingofsampleswithdifferentfilenames,suchas,Test.Trail,Demo,andtraining,etc其中部分檢測結(jié)果不符合標(biāo)準(zhǔn)Someofthetestingresultsfailedspecifications所有沒有存在網(wǎng)絡(luò)計(jì)算機(jī)中而存在個人電腦(辦公室)中的數(shù)據(jù)。Allweresavedonpersonalcomputersinsteadofanetworkcomputersystem數(shù)據(jù)完整性問題DataIntegrityIssues(6)口進(jìn)入儀器計(jì)算機(jī)系統(tǒng)沒有適當(dāng)控制Accesstoinstrument/computersystemsisnotproperlycontrolled不同分析員共享密碼(同用戶名和密碼都不行)Passwordsaresharedbydifferentanalysts審計(jì)追蹤功能沒有啟用或沒有審核AudittrailfunctionwasdisabledornotreviewedEND16、業(yè)余生活要有意義，不要越軌?！A盛頓

17、一個人即使已登