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clearfix"><section class="container clearfix tcPro"><section class="home-main container clearfix"><div id="vpb9qpb" class="twoCol"><div id="ixu4jd8" 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>?河南流式細(xì)胞儀驗(yàn)證3Q認(rèn)證誠信服務(wù) 旦霆生物科技供應(yīng)</p><div id="4jyn4qn" class="leftbox clearfix"><h1>河南流式細(xì)胞儀驗(yàn)證3Q認(rèn)證誠信服務(wù) 旦霆生物科技供應(yīng)</h1><div id="5o2gaxm" class="proBig"><div id="jprae32" class="bigimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309044736328/4167870.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="e7kcfzq" class="smallimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309044736328/4167870.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="c23kxub" 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>河南流式細(xì)胞儀驗(yàn)證3Q認(rèn)證,3Q認(rèn)證</p><p><span>***更新：</span>2021-01-21 05:04:48</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="t3qcyam" 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="bqlmd3n" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="akxm7c8" class="box"><p><p> 冰箱3Q認(rèn)證內(nèi)容包括： </p> <p> PQ內(nèi)容：1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)， 2滿載溫度分布確認(rèn)，3開門挑戰(zhàn)試驗(yàn)，4斷電挑戰(zhàn)試驗(yàn)，河南流式細(xì)胞儀驗(yàn)證3Q認(rèn)證。 </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開啟/關(guān)閉確認(rèn)4，報(bào)警功能確認(rèn)，河南流式細(xì)胞儀驗(yàn)證3Q認(rèn)證，河南流式細(xì)胞儀驗(yàn)證3Q認(rèn)證，5空載溫度分布確認(rèn) 。 </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)識確認(rèn)。 </p> <p> <br /> </p> <p> <br /> 旦霆科技不但擁有龐大的驗(yàn)證及檢測團(tuán)隊(duì)，同時(shí)配備幾百套驗(yàn)證及檢測儀器，專業(yè)開展3Q認(rèn)證服務(wù)！河南流式細(xì)胞儀驗(yàn)證3Q認(rèn)證</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河南流式細(xì)胞儀驗(yàn)證3Q認(rèn)證,3Q認(rèn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309044736328/4167870.png"></div><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 /> 河南流式細(xì)胞儀驗(yàn)證3Q認(rèn)證旦霆科技各類行業(yè)的驗(yàn)證服務(wù)經(jīng)驗(yàn)，專業(yè)為您提供3Q認(rèn)證，值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河南流式細(xì)胞儀驗(yàn)證3Q認(rèn)證,3Q認(rèn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309140878906/6136158.jpg"></div><p style="text-indent:25px">以證明某項(xiàng)工藝達(dá)到預(yù)計(jì)要求的活動。以水系統(tǒng)驗(yàn)證為例，人們很難制造一個(gè)原水污染變化的環(huán)境條件來考察水系統(tǒng)的處理能力并根據(jù)原水污染程度來確定系統(tǒng)運(yùn)行參數(shù)的調(diào)控范圍，這種條件下，同步驗(yàn)證成了合理的選擇。這種情況下，工藝驗(yàn)證的實(shí)際概念是特殊監(jiān)控條件下的試生產(chǎn)，而在試生產(chǎn)性的工藝驗(yàn)證過程中，可以同時(shí)獲得兩方面的結(jié)果：一是合格的產(chǎn)品，二是驗(yàn)證的結(jié)果，即“工藝重現(xiàn)性及可靠性”的證據(jù)。由于同步驗(yàn)證與生產(chǎn)同時(shí)進(jìn)行，因此該驗(yàn)證方式可能帶來產(chǎn)品質(zhì)量方面的風(fēng)險(xiǎn)，因此，企業(yè)應(yīng)根據(jù)自己的實(shí)際情況作出適當(dāng)?shù)倪x擇，且在制定驗(yàn)證方案并實(shí)施驗(yàn)證時(shí)，特別注意這種方式的先決條件，分析主客觀的情況并預(yù)計(jì)驗(yàn)證結(jié)果對保證質(zhì)量可靠性的風(fēng)險(xiǎn)程度。3Q認(rèn)證中，同步驗(yàn)證是在工藝常規(guī)運(yùn)行的同時(shí)進(jìn)行的驗(yàn)證，即從工藝實(shí)際運(yùn)行過程中獲得的數(shù)據(jù)來確立文件的依據(jù)</p><p> 回顧性驗(yàn)證怎么做？ </p> <p> <p> 3Q認(rèn)證中，回顧驗(yàn)證必須具備以下條件方可應(yīng)用： </p> <p> 1.至少有6批符合要求的數(shù)據(jù)，有20批以上的數(shù)據(jù)更好。 </p> <p> 2.檢驗(yàn)方法已經(jīng)過驗(yàn)證，檢驗(yàn)的結(jié)果可以用數(shù)值表示，可以進(jìn)行統(tǒng)計(jì)分析。 </p> <p> 3.批記錄符合制藥GMP要求，記錄中有明確的工藝條件，且有關(guān)于偏差的分析說明。 </p> <p> 4.有關(guān)的工藝變量是標(biāo)準(zhǔn)化的，并一直處于控制狀態(tài)，如原料標(biāo)準(zhǔn)、潔凈區(qū)的級別、分析方法、微生物控制等。 </p> <p> 5.這種方式通常用于非無菌產(chǎn)品的工藝驗(yàn)證，以積累的生產(chǎn)、檢驗(yàn)和其他有關(guān)歷史資料為依據(jù)，回顧、分析工藝控制的全過程，證實(shí)其控制條件的有效件。 </p> 旦霆科技布局細(xì)胞行業(yè)，目前為20余家相關(guān)行業(yè)的公司提供3Q認(rèn)證及咨詢等服務(wù)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河南流式細(xì)胞儀驗(yàn)證3Q認(rèn)證,3Q認(rèn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309141064453/8232012.jpg"></div><p> 潔凈工作臺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)，系統(tǒng)按鍵功能確認(rèn)，參數(shù)設(shè)置確認(rèn)，高效過濾器及其邊框完整性確認(rèn)，下降氣流流速確認(rèn)，噪聲確認(rèn)，照度確認(rèn)，氣流流型確認(rèn)，紫外線輻射強(qiáng)度確認(rèn)，報(bào)警及互鎖功能確認(rèn)，懸浮粒子確認(rèn)，沉降菌確認(rèn)，浮游菌確認(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)，懸浮粒子測試，沉降菌測試，浮游菌測試以及表面微生物測試，動態(tài)下測試三次著眼質(zhì)量，靜思細(xì)量，旦霆科技為您提供專業(yè)的“3Q認(rèn)證服務(wù)，為您的合規(guī)之路保駕護(hù)航！河南流式細(xì)胞儀驗(yàn)證3Q認(rèn)證</p><p style="text-indent:25px">旦霆科技作為國內(nèi)**的綜合性驗(yàn)證咨詢公司，專業(yè)解答各種3Q認(rèn)證及偏差處理等相關(guān)問題，歡迎您的垂詢！河南流式細(xì)胞儀驗(yàn)證3Q認(rèn)證</p><p> 倉庫Q認(rèn)證內(nèi)容包括： </p> <p> PQ內(nèi)容：1.預(yù)確認(rèn)(確認(rèn)運(yùn)行確認(rèn)是否完成，2.安裝運(yùn)行確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉)，3. 滿載溫濕度分布確認(rèn)，4.開門挑戰(zhàn)試驗(yàn)，5.斷電挑戰(zhàn)試驗(yàn) </p> <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.空調(diào)系統(tǒng)開啟/關(guān)閉確認(rèn)，4.空載溫濕度分布確認(rèn) <span style="font-size:12px;"></span> </p> </p> <p> IQ內(nèi)容: 1.文件確認(rèn)（圖紙確認(rèn)，技術(shù)文件確認(rèn)）,2.儀器/儀表校準(zhǔn)確認(rèn)，3.部件安裝確認(rèn)，4.公用系統(tǒng)連接確認(rèn)和標(biāo)識確認(rèn) </p> <p> <br /> 河南流式細(xì)胞儀驗(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/2940117.html</p></div></div></div></div></div><div id="7zjlnpl" class="page-right twoColRt"><div id="lkhj87y" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="dskhta3" 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