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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>河北區(qū)溫度監(jiān)測系統(tǒng)計(jì)算機(jī)驗(yàn)證,計(jì)算機(jī)驗(yàn)證</p><p><span>***更新：</span>2020-08-18 15:19:47</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="2ei2o2q" 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="swko2qw" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="wkksyec" class="box"><p><p> 工藝驗(yàn)證是什么，怎么做？ </p> <p> <br /> </p> <p> 旦霆科技為企業(yè)提供工藝驗(yàn)證GMP驗(yàn)證咨詢，河北區(qū)溫度監(jiān)測系統(tǒng)計(jì)算機(jī)驗(yàn)證。工藝驗(yàn)證應(yīng)當(dāng)證明一個(gè)生產(chǎn)工藝按照規(guī)定的工藝參數(shù)能夠持續(xù)生產(chǎn)出符合預(yù)定用途和注冊要求的產(chǎn)品。在工藝驗(yàn)證之前應(yīng)確定以下工作已完成: </p> <p> <br /> </p> <p> 1.所使用的設(shè)備或設(shè)施已完成安裝確認(rèn) (IQ) ，河北區(qū)溫度監(jiān)測系統(tǒng)計(jì)算機(jī)驗(yàn)證，運(yùn)行確認(rèn) (OQ) 和性能確認(rèn)（PQ）； </p> <p> <br /> </p> <p> 2.產(chǎn)品的質(zhì)量標(biāo)準(zhǔn)已確定； </p> <p> <br /> </p> <p> 3.分析方法驗(yàn)證已完成； </p> <p> <br /> </p> <p> 工藝驗(yàn)證一般要求生產(chǎn)至少連續(xù)3批，對于新產(chǎn)品的工藝驗(yàn)證，由于產(chǎn)品產(chǎn)品從小試成功，中試放大，再到商業(yè)化生產(chǎn)中一些工藝參數(shù)還不能確定，因此推薦先進(jìn)行至少1個(gè)批號的開發(fā)批工藝驗(yàn)證，河北區(qū)溫度監(jiān)測系統(tǒng)計(jì)算機(jī)驗(yàn)證，跟進(jìn)此次數(shù)據(jù)調(diào)整一些工藝參數(shù)和設(shè)備操作，為正式工藝驗(yàn)證提供可靠數(shù)據(jù)基礎(chǔ)，但開發(fā)批的產(chǎn)品必須檢驗(yàn)全部符合質(zhì)量標(biāo)準(zhǔn)，且偏差得到有效調(diào)查評估后才可關(guān)閉。根據(jù)開發(fā)批驗(yàn)證的數(shù)據(jù)修改SOP，并起草工藝驗(yàn)證方案。 </p> <p> <br /> 旦霆科技專業(yè)為國內(nèi)制藥行業(yè)提供3Q認(rèn)證服務(wù)、第三方測試執(zhí)行以及技術(shù)支持。河北區(qū)溫度監(jiān)測系統(tǒng)計(jì)算機(jī)驗(yàn)證</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北區(qū)溫度監(jiān)測系統(tǒng)計(jì)算機(jī)驗(yàn)證,計(jì)算機(jī)驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174846131826172/197945.jpg"></div><p> 什么是運(yùn)行確認(rèn)，怎么做？ </p> <p> <br /> </p> <p> GMP驗(yàn)證咨詢服務(wù)過程中運(yùn)行確認(rèn)是通過檢査、檢測等測試方式，用文件的形式證明設(shè)備的運(yùn)行狀況符合設(shè)備出廠技術(shù)參數(shù)，能滿足設(shè)備的用戶需求說明和設(shè)計(jì)確認(rèn)中的功能技術(shù)指標(biāo)，是證明系統(tǒng)或設(shè)備各項(xiàng)技術(shù)參數(shù)能否達(dá)到設(shè)定要求的一系列活動。運(yùn)行確認(rèn)應(yīng)包含以下內(nèi)容： </p> <p> <br /> </p> <p> a.先決條件確認(rèn)：確認(rèn)安裝確認(rèn)是否完成，設(shè)備/系統(tǒng)的操作/維護(hù)保養(yǎng)SOP是否完成； </p> <p> <br /> </p> <p> b.人員培訓(xùn)確認(rèn)：確認(rèn)所有參與該方案執(zhí)行的人員經(jīng)過培訓(xùn)，掌握方案測試內(nèi)容和方法，確保方案實(shí)施過程正確無誤； </p> <p> <br /> </p> <p> c.功能測試。設(shè)備的功能測試應(yīng)依據(jù)設(shè)施、設(shè)備的設(shè)計(jì)標(biāo)準(zhǔn)制定，必須關(guān)注影響產(chǎn)品質(zhì)量的關(guān)鍵參數(shù)，應(yīng)在一種或一組運(yùn)行條件之下進(jìn)行，包括設(shè)備運(yùn)行的上下限，必要時(shí)選擇“**差條件”測試應(yīng)證實(shí)設(shè)備的功能滿足預(yù)定的運(yùn)行范圍。 </p> <p> <br /> 河北區(qū)計(jì)算機(jī)驗(yàn)證驗(yàn)證服務(wù)旦霆科技以高質(zhì)量作為服務(wù)宗旨，為國內(nèi)制藥行業(yè)、醫(yī)療器械行業(yè)等眾多行業(yè)提供CSV驗(yàn)證及咨詢服務(wù)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北區(qū)溫度監(jiān)測系統(tǒng)計(jì)算機(jī)驗(yàn)證,計(jì)算機(jī)驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174842257265625/5275814.jpg"></div><p> 生物學(xué)測定方法驗(yàn)證 </p> <p> 旦霆科技為企業(yè)提供生物制品生物學(xué)分析方法GMP驗(yàn)證咨詢，生物學(xué)測定方法依賴于生物基質(zhì)（如動物、活細(xì)胞或目標(biāo)受體的功能復(fù)合體等）通常比化學(xué)實(shí)驗(yàn)變異性更大，主要的是生物活性（或效價(jià)、效力）測定。生物活性測定包括以下方法： </p> <p> 1.動物試驗(yàn)方法，2.在細(xì)胞水平上測定產(chǎn)品的生化和生理效應(yīng)的細(xì)胞培養(yǎng)檢測方法；3.利用酶反應(yīng)速率或免疫相互作用誘導(dǎo)的生物反應(yīng)等方法測定生物活性的生化檢測方法。依照方法來源不同，驗(yàn)證的要求有所不同，標(biāo)準(zhǔn)方法）通常認(rèn)為在被確定為標(biāo)準(zhǔn)方法前巳經(jīng)過驗(yàn)證，使用者在采用此類方法前只需證明實(shí)際使用條件下方法的適用性，對于非標(biāo)準(zhǔn)的方法通常需要經(jīng)過嚴(yán)格驗(yàn)證。一般情況下，需驗(yàn)證的分析項(xiàng)有：鑒別試驗(yàn)、純度和雜質(zhì)檢査、原液或制劑中有效成分的含量測定及生物活性測定。 </p> <p> <br /> </p><p> 空調(diào)系統(tǒng)與潔凈室驗(yàn)證內(nèi)容 </p> <p> 旦霆科技為企業(yè)提供空調(diào)系統(tǒng)與潔凈廠房GMP驗(yàn)證咨詢，驗(yàn)證交付物包括VP，SC，SRA，IQ，OQ，PQ，RTM以及VSR文件，其中IQ內(nèi)容包括：文件確認(rèn)（圖紙確認(rèn)/技術(shù)文件確認(rèn)/材質(zhì)證明類文件確認(rèn)/施工記錄/報(bào)告確認(rèn)）, 系統(tǒng)安全確認(rèn), 系統(tǒng)安裝環(huán)境確認(rèn), 公用介質(zhì)連接確認(rèn), 儀器儀表校準(zhǔn)確認(rèn), 潔凈區(qū)安裝確認(rèn), 空調(diào)系統(tǒng)部件安裝確認(rèn)，PLC及HMI確認(rèn)，標(biāo)識確認(rèn)以及I/O測試確認(rèn)，OQ內(nèi)容包括：系統(tǒng)啟動和關(guān)閉確認(rèn)，登錄權(quán)限確認(rèn)，HMI界面和基本功能確認(rèn)，用戶權(quán)限確認(rèn)，報(bào)警確認(rèn)，斷電恢復(fù)確認(rèn)，自動運(yùn)行確認(rèn)，風(fēng)量及換氣次數(shù)確認(rèn)測，壓差確認(rèn)，高效過濾器及邊框完整性確認(rèn)，溫度/相對濕度確，噪音確認(rèn)測，照度確認(rèn)，氣流流型確認(rèn)，自凈時(shí)間確認(rèn)，懸浮粒子確認(rèn)，浮游菌確認(rèn)，沉降菌確認(rèn)；PQ內(nèi)容包括：溫度/相對濕度確認(rèn)，懸浮粒子確認(rèn)，浮游菌確認(rèn)，沉降菌確認(rèn)測試以及表面微生物，動態(tài)執(zhí)行三次。旦霆科技成立至今為超過800多家企業(yè)提供GMP咨詢、CSV驗(yàn)證等服務(wù)，口碑良好，性價(jià)比高！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北區(qū)溫度監(jiān)測系統(tǒng)計(jì)算機(jī)驗(yàn)證,計(jì)算機(jī)驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174842202685547/731593.jpg"></div><p> 前驗(yàn)證怎么做？ </p> <p> 前驗(yàn)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(yàn)證的方式。GMP驗(yàn)證咨詢服務(wù)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> 6. 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 /> </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)，專業(yè)提供CSV驗(yàn)服務(wù)，是您放心的選擇！河北區(qū)溫度監(jiān)測系統(tǒng)計(jì)算機(jī)驗(yàn)證</p><p style="text-indent:25px">旦霆科技擁有良好的驗(yàn)證及檢測理念，為CSV驗(yàn)證服務(wù)提供保障！河北區(qū)溫度監(jiān)測系統(tǒng)計(jì)算機(jī)驗(yàn)證</p><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)GMP驗(yàn)證咨詢服務(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)，倉儲管理系統(tǒng)（WMS）" </p> <p> <br /> </p> <p> <br /> 河北區(qū)溫度監(jiān)測系統(tǒng)計(jì)算機(jī)驗(yàn)證</p><p style="text-indent:25px">旦霆生物科技（上海）有限公司創(chuàng)立于2014-04-21，是一家服務(wù)型公司。公司業(yè)務(wù)涵蓋[ "GMP驗(yàn)證咨詢與服務(wù)", "計(jì)算機(jī)化系統(tǒng)驗(yàn)證", "壓縮空氣檢測", "潔凈室檢測" ]等，價(jià)格合理，品質(zhì)有保證。公司注重以質(zhì)量為中心，以服務(wù)為理念，秉持誠信為本的理念，打造醫(yī)藥、保養(yǎng)質(zhì)量品牌。截止當(dāng)前，我公司年?duì)I業(yè)額度達(dá)到700-1000萬元，爭取在一公分的領(lǐng)域里做出一公里的深度。</p></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/957606.html</p></div></div></div></div></div><div id="4yecyek" class="page-right twoColRt"><div id="ouc2aiq" class="box01 margin10 clearfix"><h3><a 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