福建SAP系統(tǒng)滅菌柜驗(yàn)證第三方誠(chéng)信為本旦霆生物科技供應(yīng)-b2b網(wǎng)站_b2b電子商務(wù)平臺(tái)【買產(chǎn)品】-上?？谄蚴称酚邢薰?/title><meta name="description" content="第一百四十四條確認(rèn)和驗(yàn)證不是一次性的行為。首次確認(rèn)或驗(yàn)證后，應(yīng)根據(jù)產(chǎn)品質(zhì)量回顧分析的情況進(jìn)行再確認(rèn)或再驗(yàn)證。關(guān)鍵的生產(chǎn)工藝和操作規(guī)程應(yīng)定期進(jìn)行再驗(yàn)證，確保其能夠達(dá)到預(yù)期結(jié)果，福建SAP系統(tǒng)滅菌柜驗(yàn)證第三方。第一百四十八條&nbs"><meta name="keywords" content="福建SAP系統(tǒng)滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證"><link rel="canonical" href="http://www.cdcfah.com/"/><meta name="applicable-device" content="pc"><link rel="shortcut icon" href="/static/new_net_01/images/favicon.ico"><link rel="stylesheet" href="/static/new_net_01/css/slick.css" /><link rel="stylesheet" href="/static/new_net_01/css/addnew.css"><link rel="stylesheet" href="/static/new_net_01/css/sidenav.css"><link rel="stylesheet" href="/static/new_net_01/css/style.css" /><link rel="stylesheet" href="/static/new_net_01/css/tab.css"><link rel="stylesheet" href="/static/new_net_01/css/404.css"> <meta 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id="hl7gmoq" class="twoCol"><div id="foq3asf" class="page-proshow clearfix"><p class="current"> 當(dāng)前位置:<a href="http://www.cdcfah.com/">首頁(yè)?<a href="http://www.cdcfah.com/cp/">產(chǎn)品供應(yīng)</a>?<a href="http://www.cdcfah.com/cp/second-_yyby/">醫(yī)藥健康</a>?<a href="http://www.cdcfah.com/cp/third-yyby_qtflft/">其他未分類</a>?福建SAP系統(tǒng)滅菌柜驗(yàn)證第三方誠(chéng)信為本旦霆生物科技供應(yīng)</p><div id="ad7ebdf" class="leftbox clearfix"><h1>福建SAP系統(tǒng)滅菌柜驗(yàn)證第三方誠(chéng)信為本旦霆生物科技供應(yīng)</h1><div id="fjlsubn" class="proBig"><div id="ncew3hu" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295736738282/6333870.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="ztvxewi" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295736738282/6333870.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="uyvcj8d" class="content"><p><span>需求數(shù)量：</span>0</p><p><span>價(jià)格要求：</span>面議</p><p><span>所在地：</span>上海市</p><p><span>包裝要求：</span><span style="color: #f30;"></span></p><p><span>產(chǎn)品關(guān)鍵詞：</span>福建SAP系統(tǒng)滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證</p><p><span>***更新：</span>2021-01-22 09:05:29</p><p><span id="click" >瀏覽次數(shù)：0次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="svryahj" class="rightbox"><h3>公司基本資料信息</h3><p style="border:0;"><a rel="nofollow">旦霆生物科技（上海）有限公司</a></p><p><span>聯(lián)系人：</span>楊玲玲</p><p><span>郵箱: </span>847678360@qq.com</p><p><span>電話: </span>18918043358</p><p><span>傳真: </span>021_</p><p><span>網(wǎng)址: </span></p><p><span>手機(jī): </span>021-59882315</p><p><span>地址: </span>上海市青浦區(qū)華徐公路966號(hào)法姬娜大廈B323室，325室</p><p>[當(dāng)前離線] <a rel="nofollow"> [加為商友] </a><a rel="nofollow"> [發(fā)送信件] </a></p></div></div><div id="323ykm3" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="xldfmt8" class="box"><p><p> ***百四十四條確認(rèn)和驗(yàn)證不是一次性的行為。***確認(rèn)或驗(yàn)證后，應(yīng)根據(jù)產(chǎn)品質(zhì)量回顧分析的情況進(jìn)行再確認(rèn)或再驗(yàn)證。關(guān)鍵的生產(chǎn)工藝和操作規(guī)程應(yīng)定期進(jìn)行再驗(yàn)證，確保其能夠達(dá)到預(yù)期結(jié)果，福建SAP系統(tǒng)滅菌柜驗(yàn)證第三方。 </p> <p> ***百四十八條確認(rèn)或驗(yàn)證應(yīng)按照預(yù)先確定和批準(zhǔn)的方案實(shí)施，并有記錄。確認(rèn)或驗(yàn)證工作完成后，應(yīng)寫出報(bào)告，并經(jīng)審核，福建SAP系統(tǒng)滅菌柜驗(yàn)證第三方、批準(zhǔn)。確認(rèn)或驗(yàn)證的結(jié)果和結(jié)論（包括評(píng)價(jià)和建議）應(yīng)有記錄并存檔，福建SAP系統(tǒng)滅菌柜驗(yàn)證第三方。 </p> <p> ***百四十九條應(yīng)根據(jù)驗(yàn)證的結(jié)果確認(rèn)工藝規(guī)程和操作規(guī)程。專注滅菌柜及培養(yǎng)基制備，專業(yè)，精細(xì)，數(shù)據(jù)可靠！福建SAP系統(tǒng)滅菌柜驗(yàn)證第三方</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建SAP系統(tǒng)滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295736738282/6333870.png"></div><p> 設(shè)備移交后即進(jìn)入設(shè)備的后期管理階段，該階段是依據(jù)設(shè)備驗(yàn)證過(guò)程中確定的標(biāo)準(zhǔn)、規(guī)定來(lái)規(guī)范設(shè)備的運(yùn)行、使用狀況。當(dāng)出現(xiàn)異常狀況后，則需要從新審核驗(yàn)證階段確定的規(guī)定，甚至設(shè)備管理規(guī)程，制定新的規(guī)定，或進(jìn)行設(shè)備再驗(yàn)證，完成設(shè)備管理的PDCA循環(huán)。 </p> <p> 在設(shè)備的后期管理中，同樣與設(shè)備的驗(yàn)證相關(guān)，此階段的驗(yàn)證以再驗(yàn)證為主，當(dāng)懷疑設(shè)備生產(chǎn)不穩(wěn)定時(shí)，也可以進(jìn)行再驗(yàn)證。通過(guò)再驗(yàn)證，證實(shí)設(shè)備完好、穩(wěn)定，操作方法、維護(hù)方法正確，參數(shù)恒定。當(dāng)設(shè)備經(jīng)過(guò)大修后，亦進(jìn)行再驗(yàn)證。 </p> <p> <br /> 福建SAP系統(tǒng)滅菌柜驗(yàn)證第三方旦霆科技配備幾百套驗(yàn)證及檢測(cè)儀器，專業(yè)的驗(yàn)證及檢測(cè)服務(wù)團(tuán)隊(duì)，專業(yè)提供驗(yàn)證服務(wù)，服務(wù)區(qū)域覆蓋全國(guó)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建SAP系統(tǒng)滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295339033204/3936007.png"></div><p> 空載測(cè)試 </p> <p> 空載熱分布 </p> <p> 測(cè)試過(guò)程：取9支經(jīng)過(guò)校驗(yàn)的留點(diǎn)溫度計(jì)，將其中一支的探頭置于滅菌器的蒸汽進(jìn)氣口處，一支探頭置于滅菌器排氣口處，一支探頭置于滅菌器的溫度控制和記錄的探頭旁邊，其余留點(diǎn)溫度計(jì)的分布在腔內(nèi)的各處。開(kāi)啟滅菌器箱，按照標(biāo)準(zhǔn)程序進(jìn)行，運(yùn)行過(guò)程中記錄儀器記錄各個(gè)點(diǎn)的溫度連續(xù)運(yùn)行3次，檢查其重現(xiàn)性。 </p> <p> 生物指示劑測(cè)試：在比較大負(fù)載情況下（占滅菌容積的2/3）測(cè)試，將高壓物品均勻放置在腔室內(nèi)各處，不接觸腔室內(nèi)壁。在高壓電熱壓力蒸汽消毒器腔體內(nèi)放置生物指示卡，按照壓力消毒器運(yùn)行的標(biāo)準(zhǔn)操作程序，121°C20分鐘運(yùn)行消毒。空載測(cè)試應(yīng)連續(xù)進(jìn)行3次，以檢驗(yàn)其重現(xiàn)性。分析滅菌效果。 </p> <p> <br /> </p> <p> <br /> </p><p style="text-indent:25px">設(shè)備運(yùn)行確認(rèn)，就是設(shè)備各個(gè)功能的依次確認(rèn)，在設(shè)備管理中，為設(shè)備的試機(jī)，或試運(yùn)行。概括來(lái)講，設(shè)備主要包括四個(gè)方面的功能確認(rèn)：操作功能、安全功能、警示功能和生產(chǎn)功能。操作功能指設(shè)備的可操作性、操作的方便性，安全功能指設(shè)備有防護(hù)人身傷害的功能，警示功能指設(shè)備使用過(guò)程中超出規(guī)定限度時(shí)的報(bào)警功能，生產(chǎn)功能是指設(shè)備能夠生產(chǎn)出合格的產(chǎn)品。當(dāng)設(shè)備的功能齊全后，方可進(jìn)行下一步的工作。對(duì)部分設(shè)備而言，生產(chǎn)功能試驗(yàn)須有參數(shù)的確認(rèn)（如梯度試驗(yàn)），以及基本確定設(shè)備的操作方法、維護(hù)方法等，人員應(yīng)經(jīng)過(guò)操作、維護(hù)的基本培訓(xùn)。旦霆科技年度營(yíng)業(yè)額以50%的速度高速增長(zhǎng)，逐漸成為為數(shù)不多的中大型儀器設(shè)備驗(yàn)證測(cè)試服務(wù)的綜合性公司。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="福建SAP系統(tǒng)滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294441425782/9841184.png"></div><p style="text-indent:25px">設(shè)備管理的含義：設(shè)備管理，是以企業(yè)生產(chǎn)經(jīng)營(yíng)目標(biāo)為依據(jù)，通過(guò)一系列的技術(shù)、經(jīng)濟(jì)、組織措施，對(duì)設(shè)備的規(guī)劃、設(shè)計(jì)、制造、選型、購(gòu)置、安裝、使用、維護(hù)、修理、改造、更新直至報(bào)廢的全過(guò)程進(jìn)行科學(xué)的管理；它包括設(shè)備的物質(zhì)運(yùn)動(dòng)和價(jià)值運(yùn)動(dòng)兩個(gè)方面的管理工作。根據(jù)設(shè)備管理的內(nèi)容，我們一般將其分為三個(gè)階段，即設(shè)備的前期管理、后期管理和設(shè)備管理的過(guò)渡階段。前期管理包括設(shè)備的規(guī)劃、設(shè)計(jì)、制造、選型、購(gòu)置；后期管理包括設(shè)備的使用、維護(hù)、修理、改造、更新直至報(bào)廢；過(guò)渡階段為設(shè)備的驗(yàn)證、初期使用和移交。旦霆科技在提供高質(zhì)量服務(wù)的同時(shí)為眾多客戶解決項(xiàng)目偏差、驗(yàn)證偏差等問(wèn)題。以保證3Q認(rèn)證服務(wù)的順利進(jìn)行。浙江BMS系統(tǒng)滅菌柜驗(yàn)證第三方</p><p style="text-indent:25px">旦霆科技不但擁有龐大的驗(yàn)證及檢測(cè)團(tuán)隊(duì)，同時(shí)配備幾百套驗(yàn)證及檢測(cè)儀器，專業(yè)開(kāi)展滅菌柜驗(yàn)證服務(wù)！福建SAP系統(tǒng)滅菌柜驗(yàn)證第三方</p><p> 歐盟GMP (WHO附錄4）附錄15：確認(rèn)和驗(yàn)證 </p> <p> 必須制定相關(guān)的驗(yàn)證方案，詳細(xì)說(shuō)明確認(rèn)和驗(yàn)證將如何進(jìn)行。方案應(yīng)當(dāng)經(jīng)過(guò)審核和批準(zhǔn)。驗(yàn)證方案應(yīng)詳細(xì)描述關(guān)鍵步驟和可接受標(biāo)準(zhǔn)。 </p> <p> 應(yīng)按照確認(rèn)和/或驗(yàn)證方案編寫驗(yàn)證報(bào)告，匯總獲得的數(shù)據(jù)和結(jié)果、對(duì)觀察到的偏差進(jìn)行評(píng)估、得出必要的結(jié)論，提出必要的糾偏措施。確認(rèn)/驗(yàn)證方案中的計(jì)劃的變更，應(yīng)有相應(yīng)記錄并有適當(dāng)?shù)慕忉尅?</p> <p> 確認(rèn)完成且結(jié)果令人滿意時(shí)，應(yīng)有書面批準(zhǔn)，同意進(jìn)入下一步的確認(rèn)和驗(yàn)證工作。 </p> <p> <br /> 福建SAP系統(tǒng)滅菌柜驗(yàn)證第三方</p><p> 旦霆生物科技（上海）有限公司是一家為制藥、化工、化妝品、保健食品、制藥設(shè)備等行業(yè)提供GXP合規(guī)咨詢、驗(yàn)證服務(wù)以及培訓(xùn)的綜合性咨詢公司； </p> <p> 旦霆公司長(zhǎng)期致力于幫助企業(yè)順利通過(guò)FDA EU TGA WHO CFDA等機(jī)構(gòu)的GMP認(rèn)證檢查； </p> <p> 公司成員多來(lái)自于**外資制藥企業(yè)、外資GMP咨詢公司、及國(guó)內(nèi)**的第三方檢測(cè)公司。 </p> <p> 作為以慈善事業(yè)為使命的旦霆公司堅(jiān)持以超值的品質(zhì)為客戶提供服務(wù)，同時(shí)公司每年利潤(rùn)的10%捐獻(xiàn)給中國(guó)貧困兒童，持久資助中國(guó)貧困兒童的教育。 </p></p><br /><p>文章來(lái)源地址: http://www.cdcfah.com/cp/2960269.html</p></div></div></div></div></div><div id="7pw2s3x" class="page-right twoColRt"><div id="fphzb2d" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="3vs3jnj" class="recomPic 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