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clearfix"><div id="j7uwo33" class="twoCol"><div id="9zedkmg" 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/first-_yyby/">醫(yī)藥健康</a>?<a href="http://www.cdcfah.com/cp/second-yyby_swzp/">生物制品</a>?<a href="http://www.cdcfah.com/cp/third-swzp_qtswzp/">其他生物制品</a>?安徽運(yùn)輸車驗證咨詢公司誠信服務(wù) 旦霆生物科技供應(yīng)</p><div id="he38eqs" class="leftbox clearfix"><h1>安徽運(yùn)輸車驗證咨詢公司誠信服務(wù) 旦霆生物科技供應(yīng)</h1><div id="visjlsj" class="proBig"><div id="1amovhe" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431512939453/2814885.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="dwtq7e2" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431512939453/2814885.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="zbtvhzl" class="content"><p><span>需求數(shù)量：</span>0</p><p><span>價格要求：</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>安徽運(yùn)輸車驗證咨詢公司,驗證咨詢公司</p><p><span>***更新：</span>2020-12-19 07:06:06</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="jczwovs" 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="c2pmtfh" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="cacelrt" class="box"><p><p> 常見驗證文件并釋意 </p> <p> GMP驗證咨詢服務(wù)常見驗證交付物釋意如下：用戶需求（URS）：指使用方對廠房、設(shè)施、設(shè)備或其他系統(tǒng)提出的要求及期望；驗證總計劃（VMP）：是對整個驗證計劃的概述；驗證計劃（VP）：針對于大型復(fù)雜項目，驗證總計劃將整個項目再劃分成多個小項目，按照其特點(diǎn)來編寫驗證計劃和方案；風(fēng)險評估（RA）：一種用于評估并描述系統(tǒng)、設(shè)備或工藝的關(guān)鍵方面（CQA/CPP），以確定系統(tǒng)、設(shè)備驗證的范圍和程度的方法；設(shè)計確認(rèn)（DQ）：在設(shè)備建造前，對設(shè)備設(shè)計文件（用戶需求說明、功能設(shè)計說明、詳細(xì)設(shè)計說明等）進(jìn)行檢査確保能夠完全滿足用戶需求說明及GMP中的所有要求；安裝確認(rèn)（IQ）：為確認(rèn)安裝或改造后的設(shè)施、系統(tǒng)和設(shè)備符合已批準(zhǔn)的設(shè)計及制造商建議所作的各種查證及文件記錄，安徽運(yùn)輸車驗證咨詢公司，新的或改造的廠房、設(shè)施、設(shè)備需進(jìn)行安裝確認(rèn)；運(yùn)行確認(rèn)（OQ）：應(yīng)當(dāng)證明廠房、設(shè)施、設(shè)備的運(yùn)行符合設(shè)計標(biāo)準(zhǔn)；性能確認(rèn)（PQ）：性能確認(rèn)目的在于證明廠房、設(shè)施，安徽運(yùn)輸車驗證咨詢公司、設(shè)備在正常操作方法和工藝條件下能夠持續(xù)符合標(biāo)準(zhǔn)，性能確認(rèn)方案的制定應(yīng)依據(jù)已有的生產(chǎn)工藝、設(shè)施和設(shè)備的相關(guān)知識，使用生產(chǎn)物料、適當(dāng)?shù)奶娲坊蛘吣M產(chǎn)品來進(jìn)行試驗/測試；需求追溯矩陣。旦霆科技擁有先進(jìn)的驗證理念，成熟的驗證體系，安徽運(yùn)輸車驗證咨詢公司，為您提供專業(yè)、質(zhì)量的計算機(jī)化系統(tǒng)驗證服務(wù)。安徽運(yùn)輸車驗證咨詢公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽運(yùn)輸車驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431512939453/2814885.jpg"></div><p> 生物制品生產(chǎn)設(shè)備和系統(tǒng)中一般被定義為直接影響系統(tǒng)的有： </p> <p> 1. 配液罐系統(tǒng) </p> <p> 2. 反應(yīng)罐系統(tǒng) </p> <p> 3. 超濾系統(tǒng) </p> <p> 離心機(jī)系統(tǒng) </p> <p> 旦霆科技為企業(yè)提供生物制品工藝驗證GMP驗證咨詢，按照工藝流程： </p> <p> 細(xì)胞庫制備及保存設(shè)備：液氮罐，超低溫冰箱，搖床，培養(yǎng)箱，倒置顯微鏡，生化分析儀，細(xì)胞計數(shù)儀，流式細(xì)胞儀，程序降溫儀等； </p> <p> 細(xì)胞復(fù)蘇過程：水浴鍋，生物安全柜，恒溫培養(yǎng)箱，搖床，CO2培養(yǎng)箱等； </p> <p> 細(xì)胞培養(yǎng)、傳代過程：生物反應(yīng)器； </p> <p> 收貨過程：過濾系統(tǒng)，收集罐，中轉(zhuǎn)罐等； </p> <p> 純化和精制過程：離心機(jī)，層析系統(tǒng)（蛋白純化柱，GE AKTA蛋白純化儀等）過濾系統(tǒng)，除菌過濾系統(tǒng)；安徽運(yùn)輸車驗證咨詢公司旦霆科技作為專業(yè)驗證檢測供應(yīng)商，具備CMA資質(zhì)，專業(yè)提供CSV驗服務(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="安徽運(yùn)輸車驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431491503906/5150702.png"></div><p> 我司目前已提供以下常見實驗室儀器{3Q驗GMP驗證咨詢服務(wù)： </p> <p> 存儲類：冷藏箱，低溫冰箱，超低溫冰箱，液氮儲存罐，程序降溫儀 </p> <p> 其他類:CO2培養(yǎng)箱，生化培養(yǎng)箱，震蕩培養(yǎng)箱，電熱鼓風(fēng)干燥箱，生物安全柜，超凈工作臺，通風(fēng)櫥、層流罩、手套箱、隔離器，離心機(jī)（冷凍，微量，96孔板），水浴槽，全自動蛋白純化儀，純水儀，洗板機(jī)，滅菌鍋，干式細(xì)胞融化儀，血液分析系統(tǒng) </p> <p> 生化檢測類：細(xì)胞計數(shù)儀，流式細(xì)胞儀實時熒光定量PCR儀，全自動微生物培養(yǎng)系統(tǒng)，酶標(biāo)儀，凝膠成像系統(tǒng)，倒置顯微鏡，菌落計數(shù)器 </p> <p> 理化檢測類：電泳儀，電導(dǎo)率儀，紫外分光光度計，紅外分光光度計，可見分光光度計，高效液相色譜儀，氣相色譜儀，原子吸收光譜儀、質(zhì)譜儀，液質(zhì)聯(lián)用/氣質(zhì)聯(lián)用，滲透壓儀，pH計，分析天平/電子天平，血細(xì)胞分析儀 </p> <p> <br /> </p> <p> </p> <p> <br /> </p> <p> </p><p> 什么是設(shè)計確認(rèn)，怎么做？ </p> <p> GMP驗證咨詢服務(wù)過程中設(shè)計確認(rèn)是指在安裝/運(yùn)行/性能確認(rèn)之前，按照用戶提出的需求，通過文件記錄的方式證明所提出的廠房、系統(tǒng)和設(shè)備的設(shè)計適用于其預(yù)期用途和GxP的要求，用科學(xué)的理論和實際的數(shù)據(jù)證明設(shè)計結(jié)果滿足用戶需求說明。設(shè)計確認(rèn)執(zhí)行過程中可通過表格的方式對用戶需求是否在設(shè)計文件中得以實現(xiàn)進(jìn)行詳細(xì)的比對，且詳細(xì)記錄設(shè)計文件如何滿足相應(yīng)的用戶需求，并對相應(yīng)的設(shè)計文件進(jìn)行詳細(xì)索引，設(shè)計確認(rèn)過程中對于不能滿足的用戶需求應(yīng)進(jìn)行記錄，并通過評估以及與供應(yīng)商溝通的方式，確認(rèn)需求是否關(guān)鍵或者設(shè)備/系統(tǒng)是否需要進(jìn)行升級。經(jīng)過批準(zhǔn)的設(shè)計確認(rèn)報告是后續(xù)確認(rèn)活動（如安裝確認(rèn)、運(yùn)行確認(rèn)、性能確認(rèn)）的基礎(chǔ)。 </p> <p> <br /> </p> <p> <br /> 旦霆科技提供技術(shù)咨詢、3Q認(rèn)證、驗證及檢測服務(wù)。在您不知道具體項目需求時為您擇優(yōu)推薦！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽運(yùn)輸車驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431490947265/9085575.png"></div><p> 什么是4Q? </p> <p> 關(guān)于儀器驗證，比如說，一套完整的儀器設(shè)備驗證方案，將包括4個部分，即4Q，分別為： </p> <p> DQ，設(shè)計確認(rèn)：確認(rèn)設(shè)備的設(shè)計符合用戶需求規(guī)范及相關(guān)法規(guī)。 </p> <p> IQ，安裝確認(rèn)：確認(rèn)儀器文件、部件及安裝過程。 </p> <p> OQ，運(yùn)行確認(rèn)：確認(rèn)儀器在空轉(zhuǎn)狀態(tài)下，在操作的極限范圍內(nèi)能正常的運(yùn)轉(zhuǎn)。 </p> <p> PQ，性能確認(rèn)：確認(rèn)儀器載樣運(yùn)行下是否符合標(biāo)準(zhǔn)規(guī)定。 </p> <p> <p> 什么是3Q? </p> <p> 由于實驗室所用儀器均有儀器廠家研發(fā)設(shè)計而成，因此DQ(設(shè)計確認(rèn))在儀器驗證中可以不做，所以本文提到的3Q，是指以上IQ(安裝確認(rèn))、OQ(運(yùn)行確認(rèn))、PQ(性能確認(rèn))。 </p> <p> 也就是說實驗室儀器驗證是從IQ(安裝確認(rèn))做起，再做OQ(運(yùn)行確認(rèn))、PQ(性能確認(rèn))，就完成了一套儀器驗證的整套資料。 </p> 旦霆科技擁有幾百套進(jìn)口及國產(chǎn)儀器，提供專業(yè)csv驗證及檢測服務(wù)，在承接眾多業(yè)務(wù)下保證設(shè)備充足！安徽運(yùn)輸車驗證咨詢公司</p><p style="text-indent:25px">旦霆科技為提升各項目質(zhì)量水平，成立質(zhì)量部門。為3Q認(rèn)證等驗證及檢測服務(wù)保駕護(hù)航！安徽運(yùn)輸車驗證咨詢公司</p><p> 前驗證怎么做？ </p> <p> 前驗證怎么做新品、新型設(shè)備及其生產(chǎn)工藝的引入應(yīng)采用前驗證的方式。GMP驗證咨詢服務(wù)中前驗證的目標(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，實施前以下工作應(yīng)已完成： </p> <p> 1. 配方的設(shè)計、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> 6. 前驗證實施前，生產(chǎn)和管理人員都已進(jìn)行了必要的培訓(xùn)，***的了解所需驗證的工藝及其要求。 </p> <p> <br /> </p> <p> </p> <p> <br /> </p> <p> 安徽運(yùn)輸車驗證咨詢公司</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持以超值的品質(zhì)為客戶提供服務(wù)，同時公司每年利潤的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/2469167.html</p></div></div></div></div></div><div id="j7yfx2c" class="page-right twoColRt"><div id="bq7szv7" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div 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