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data-type="member" class="">公司</a><a href="JavaScript:;" data-type="article" class="">資訊</a><a href="JavaScript:;" data-type="exhibition" class="">展會(huì)</a></div><div id="bbftp9p" class="clearfix searchWrap"><div id="zhzr7jp" class="searchInput"><input type="text" name="keywords" placeholder="請(qǐng)輸入搜索關(guān)鍵詞" id="kd"><a href="javascript:void(0)" class="searchBtn" id="search">搜索</a></div></div></div></div></header><nav class="navbox"><div id="zzvrt7f" class="container"><ul><li id = "index_index"><a href="http://www.cdcfah.com/"><span>首頁</span></a></li><li id = "index_company"><a ><span>企業(yè)名錄</span></a></li><li id = "index_product"><a href="http://www.cdcfah.com/cp/"><span>產(chǎn)品供應(yīng)</span></a></li><li id = "index_news"><a href="http://www.cdcfah.com/zx/"><span>新聞資訊</span></a></li><li id = "index_article"><a href="http://www.cdcfah.com/xw/"><span>行業(yè)資訊</span></a></li><li id = "index_show"><a href="http://www.cdcfah.com/zh/"><span>展會(huì)信息</span></a></li></ul></div></nav><section class="wrap clearfix"><section class="container clearfix tcPro"><section class="home-main container clearfix"><div id="prnbfrv" class="twoCol"><div id="lvrxtxh" class="page-proshow clearfix"><p class="current"> 當(dāng)前位置:<a href="http://www.cdcfah.com/">首頁?<a href="http://www.cdcfah.com/cp/">產(chǎn)品供應(yīng)</a>?<a href="http://www.cdcfah.com/cp/second-_swfw/">商務(wù)服務(wù)</a>?<a href="http://www.cdcfah.com/cp/third-swfw_jiancefuwu/">檢測服務(wù)</a>?江西CO2分配系統(tǒng)驗(yàn)證3Q認(rèn)證誠信服務(wù) 旦霆生物科技供應(yīng)</p><div id="7dfbptx" class="leftbox clearfix"><h1>江西CO2分配系統(tǒng)驗(yàn)證3Q認(rèn)證誠信服務(wù) 旦霆生物科技供應(yīng)</h1><div id="fhn995b" class="proBig"><div id="lv7nhlp" class="bigimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309138359375/982422.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="p77r7np" class="smallimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309138359375/982422.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="zb7nrdj" 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>江西CO2分配系統(tǒng)驗(yàn)證3Q認(rèn)證,3Q認(rèn)證</p><p><span>***更新：</span>2021-01-20 01:04:41</p><p><span id="click" >瀏覽次數(shù)：2次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="fnbvjnh" 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="lpvjf77" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="b7b9vbt" class="box"><p><p> 倉庫3Q認(rèn)證內(nèi)容包括： </p> <p> PQ內(nèi)容：預(yù)確認(rèn)(確認(rèn)運(yùn)行確認(rèn)是否完成，安裝運(yùn)行確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉)，滿載溫濕度分布確認(rèn)，開門挑戰(zhàn)試驗(yàn)，斷電挑戰(zhàn)試驗(yàn)。 </p> <p> OQ內(nèi)容：預(yù)確認(rèn)(確認(rèn)安裝確認(rèn)是否完成,安裝確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉，設(shè)備操作SOP是否已審批完成)，空調(diào)系統(tǒng)開啟/關(guān)閉確認(rèn)，空載溫濕度分布確認(rèn)，江西CO2分配系統(tǒng)驗(yàn)證3Q認(rèn)證。 </p> <p> IQ內(nèi)容: 文件確認(rèn)（圖紙確認(rèn)，技術(shù)文件確認(rèn)）, 倉庫門禁安全確認(rèn)，儀器/儀表校準(zhǔn)確認(rèn)，江西CO2分配系統(tǒng)驗(yàn)證3Q認(rèn)證，部件安裝確認(rèn)，江西CO2分配系統(tǒng)驗(yàn)證3Q認(rèn)證，公用系統(tǒng)連接確認(rèn)和標(biāo)識(shí)確認(rèn) </p> <p> 。 </p> <p> <br /> 旦霆科技是國內(nèi)無數(shù)不多的為制藥及醫(yī)療器械等相關(guān)行業(yè)提供3Q認(rèn)證服務(wù)的專業(yè)第三方咨詢公司。江西CO2分配系統(tǒng)驗(yàn)證3Q認(rèn)證</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江西CO2分配系統(tǒng)驗(yàn)證3Q認(rèn)證,3Q認(rèn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309138359375/982422.jpg"></div><p> 制藥行業(yè)公用系統(tǒng)清單 </p> <p> 按照ISPE 基準(zhǔn)指南《調(diào)試與確認(rèn)》第二版,可根據(jù)系統(tǒng)影響產(chǎn)品質(zhì)量的能力將系統(tǒng)分為兩類，直接影響系統(tǒng)和非直接影響系統(tǒng)，我司目前已為多家制藥行業(yè)/醫(yī)療器械行業(yè)提供以下常見公用系統(tǒng)3Q認(rèn)證服務(wù)：凈化空調(diào)系統(tǒng)（HVAC），潔凈廠房，倉庫及稱量間，制藥用水系統(tǒng)（純化水系統(tǒng)，注射用水系統(tǒng)），純蒸汽系統(tǒng)，工藝氣體系統(tǒng)（包括CO2系統(tǒng)，N2系統(tǒng)，壓縮空氣系統(tǒng)，O2系統(tǒng)），樓宇管理系統(tǒng)（BMS），環(huán)境監(jiān)測系統(tǒng)（EMS）系統(tǒng)，倉儲(chǔ)管理系統(tǒng)（WMS）甘肅負(fù)80度冰箱驗(yàn)證3Q認(rèn)證旦霆科技配備專業(yè)的質(zhì)量部，進(jìn)行驗(yàn)證審核、報(bào)告審核等質(zhì)量監(jiān)管，專業(yè)提供3Q認(rèn)證及咨詢服務(wù)，值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江西CO2分配系統(tǒng)驗(yàn)證3Q認(rèn)證,3Q認(rèn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637188431513144531/7614493.jpg"></div><p> 什么是用戶需求，用戶需求包含什么內(nèi)容？ </p> <p> 3Q認(rèn)證中，用戶需求（URS）是指用戶為滿足GMP法規(guī)、工藝用途等提出的對(duì)設(shè)備及相關(guān)系統(tǒng)的要求，因此，用戶需求編制應(yīng)依據(jù)工藝規(guī)程和法規(guī)要求，其內(nèi)容包括技術(shù)、GxP、生物安全、操作安全等相關(guān)方面。用戶應(yīng)對(duì)所有用戶需求進(jìn)行編號(hào)以便追蹤，并將其分類為與GMP相關(guān)和不相關(guān)，GMP相關(guān)需求構(gòu)成確認(rèn)和驗(yàn)證的基礎(chǔ)。用戶需求編制時(shí)應(yīng)注意，文件應(yīng)描述系統(tǒng)“應(yīng)該做到的”，而不是“如何做”，用戶應(yīng)在與系統(tǒng)供應(yīng)商溝通后確定“如何做”，并將其記錄在功能設(shè)計(jì)規(guī)范和詳細(xì)設(shè)計(jì)規(guī)范中。 </p><p> 前驗(yàn)證怎么做？ </p> <p> <br /> </p> <p> 新品、新型設(shè)備及其生產(chǎn)工藝的引入應(yīng)采用前驗(yàn)證的方式。3Q認(rèn)證中前驗(yàn)證的目標(biāo)考察并確認(rèn)工藝的重現(xiàn)性及可靠性，因此前驗(yàn)證前必須有比較充分和完整的產(chǎn)品和工藝的開發(fā)資料，實(shí)施前以下工作應(yīng)已完成： </p> <p> 1. 配方的設(shè)計(jì)、篩選及推薦已完成； </p> <p> 2. 中試性生產(chǎn)已完成，關(guān)鍵的工藝及工藝變量已經(jīng)確定，相應(yīng)參數(shù)的控制限已經(jīng)摸清； </p> <p> 3. 已有生產(chǎn)工藝方面的詳細(xì)技術(shù)資料，包括有文件記載的產(chǎn)品穩(wěn)定性考察資料； </p> <p> 4. 即使是比較簡單的工藝，也已完成了一個(gè)批號(hào)的試生產(chǎn)。 </p> <p> 5. 中試放大至試生產(chǎn)中應(yīng)無明顯的“數(shù)據(jù)漂移”或“工藝過程的因果關(guān)系發(fā)生畸變”現(xiàn)象。 </p> <p> 前驗(yàn)證實(shí)施前，生產(chǎn)和管理人員都已進(jìn)行了必要的培訓(xùn)，***的了解所需驗(yàn)證的工藝及其要求。 </p> <p> <br /> 旦霆科技作為專業(yè)驗(yàn)證檢測供應(yīng)商，具備CMA資質(zhì)，檢測報(bào)告國家認(rèn)可，專業(yè)提供3Q認(rèn)證服務(wù)，是您放心的選擇！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江西CO2分配系統(tǒng)驗(yàn)證3Q認(rèn)證,3Q認(rèn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309140878906/6136158.jpg"></div><p> 離心機(jī)3Q認(rèn)證內(nèi)容包括： </p> <p> IQ內(nèi)容: 1.技術(shù)類文件確認(rèn), 2.設(shè)備儀表校準(zhǔn)確認(rèn), 3.安裝位置和安裝環(huán)境確認(rèn), 4.部件安裝確認(rèn), 5.公用系統(tǒng)連接確認(rèn)和標(biāo)識(shí)確認(rèn) </p> <p> OQ內(nèi)容：1.預(yù)確認(rèn)(確認(rèn)安裝確認(rèn)是否完成,安裝確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉，2.設(shè)備操作SOP是否已審批完成)，3.啟動(dòng)/關(guān)閉確認(rèn)，4.按鍵功能確認(rèn)，5.參數(shù)設(shè)置功能確認(rèn)，6.轉(zhuǎn)速確認(rèn)，7.計(jì)時(shí)器比對(duì)確認(rèn)，8.溫度控制功能確認(rèn)，9.升/降速時(shí)間確認(rèn)，10。噪聲確認(rèn)，11.報(bào)警/安全功能確認(rèn) </p> <p> PQ內(nèi)容：1.根據(jù)甲方SOP運(yùn)行3次旦霆科技成員具備10年以上工作經(jīng)驗(yàn)、良好的GMP理念、熟悉精通國內(nèi)外相關(guān)法規(guī)，可專業(yè)開展3Q認(rèn)證服務(wù)！江西CO2分配系統(tǒng)驗(yàn)證3Q認(rèn)證</p><p style="text-indent:25px">旦霆科技擁有先進(jìn)的驗(yàn)證理念，成熟的驗(yàn)證體系，為您提供專業(yè)、質(zhì)量的3Q認(rèn)證服務(wù)。江西CO2分配系統(tǒng)驗(yàn)證3Q認(rèn)證</p><p> 細(xì)胞計(jì)數(shù)儀3Q認(rèn)證內(nèi)容包括： </p> <p> IQ內(nèi)容: 技術(shù)類文件確認(rèn), 設(shè)備儀表校準(zhǔn)確認(rèn), 安裝位置和安裝環(huán)境確認(rèn), 部件安裝確認(rèn), 公用系統(tǒng)連接確認(rèn)和標(biāo)識(shí)確認(rèn) </p> <p> OQ內(nèi)容：預(yù)確認(rèn)(確認(rèn)安裝確認(rèn)是否完成,安裝確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉，設(shè)備操作SOP是否已審批完成)，開啟/關(guān)閉確認(rèn)，測量模式配置確認(rèn)，校零功能確認(rèn)，基本檢測功能確認(rèn)，數(shù)據(jù)重新處理功能確認(rèn)，打印功能確認(rèn)，數(shù)據(jù)導(dǎo)出功能確認(rèn)，斷電恢復(fù)確認(rèn) </p> <p> PQ內(nèi)容：預(yù)確認(rèn)(確認(rèn)運(yùn)行確認(rèn)是否完成，安裝運(yùn)行確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉)，檢測流程確認(rèn)，攜帶污染率確認(rèn)，重復(fù)性確認(rèn) 江西CO2分配系統(tǒng)驗(yàn)證3Q認(rèn)證</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> 旦霆公司長期致力于幫助企業(yè)順利通過FDA EU TGA WHO CFDA等機(jī)構(gòu)的GMP認(rèn)證檢查； </p> <p> 公司成員多來自于**外資制藥企業(yè)、外資GMP咨詢公司、及國內(nèi)**的第三方檢測公司。 </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)公司每年利潤的10%捐獻(xiàn)給中國貧困兒童，持久資助中國貧困兒童的教育。 </p></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/2920036.html</p></div></div></div></div></div><div id="vxtp9n7" class="page-right twoColRt"><div id="t7bndpj" class="box01 margin10 clearfix"><h3><a 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