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onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="e3euwqu" 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>上海去磁設備驗證3Q認證,3Q認證</p><p><span>***更新：</span>2021-01-17 08:04:28</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="bsri3um" 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: </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="o2tqxzl" class="page-proshow02"><p class="title">詳細說明</p><div id="nzqsprt" class="box"><p><p> 倉庫3Q認證內(nèi)容包括： </p> <p> PQ內(nèi)容：預確認(確認運行確認是否完成，安裝運行確認中出現(xiàn)的偏差是否已關(guān)閉)，滿載溫濕度分布確認，開門挑戰(zhàn)試驗，斷電挑戰(zhàn)試驗。 </p> <p> OQ內(nèi)容：預確認(確認安裝確認是否完成,安裝確認中出現(xiàn)的偏差是否已關(guān)閉，設備操作SOP是否已審批完成)，空調(diào)系統(tǒng)開啟/關(guān)閉確認，空載溫濕度分布確認，上海去磁設備驗證3Q認證。 </p> <p> IQ內(nèi)容: 文件確認（圖紙確認，技術(shù)文件確認）, 倉庫門禁安全確認，儀器/儀表校準確認，上海去磁設備驗證3Q認證，部件安裝確認，公用系統(tǒng)連接確認和標識確認 </p> <p> 。 </p> <p> <br /> 旦霆科技取得了客戶的持續(xù)好評，我們將不斷完善，上海去磁設備驗證3Q認證，繼續(xù)以高質(zhì)量服務為客戶提供3Q認證、技術(shù)支持及咨詢服務!上海去磁設備驗證3Q認證</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="上海去磁設備驗證3Q認證,3Q認證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309140878906/6136158.jpg"></div><p> 什么是系統(tǒng)分類（SC），怎么做？ </p> <p> ISPE基準指南卷5《調(diào)試與確認》(2019）中列出以下8個問題將系統(tǒng)分為直接影響系統(tǒng)和間接影響系統(tǒng)，如其中一個問題回答為”是”，則改系統(tǒng)應判定為直接影響系統(tǒng)，我司可提供3Q認證；1.系統(tǒng)是否包含CAs/CDEs或執(zhí)行滿足包括CPPs在內(nèi)的一個或多個流程需求(CQAs)的功能?2.系統(tǒng)是否與產(chǎn)品或生產(chǎn)流程有直接接觸，并且這種接觸有可能影響**終產(chǎn)品質(zhì)量或?qū)颊邩?gòu)成風險?3.該系統(tǒng)是否提供輔料或生產(chǎn)成分或溶劑(如WFI)，以及該物質(zhì)的質(zhì)量(以其質(zhì)量標準而論)是否會影響**終產(chǎn)品質(zhì)量或?qū)颊邩?gòu)成風險?4.系統(tǒng)是否用于清潔、消毒或滅菌，系統(tǒng)故障是否會導致無法充分清潔、消毒或滅菌，從而給患者帶來風險?5.系統(tǒng)建立一個適當?shù)沫h(huán)境(如氮氣保護，密閉流程，暴露灌裝區(qū)區(qū)空氣質(zhì)量，維持產(chǎn)品溫濕度等等產(chǎn)品關(guān)鍵工藝參數(shù))，這前列程失效情況下，其功能會導致患者健康的風險?6.系統(tǒng)是否使用、生產(chǎn)、處理或存儲用于接受或拒絕產(chǎn)品、CPPS 或電子記錄的數(shù)據(jù)，以符合 21CFR第11部和歐盟 GMP 第 4 卷第 11部[21]或本地同等標準?7.該系統(tǒng)是否提供容器封口或產(chǎn)品保護，如果封口或產(chǎn)品保護失敗，將對患者構(gòu)成風險或產(chǎn)品質(zhì)量下降? 上海去磁設備驗證3Q認證旦霆科技成員具備10年以上工作經(jīng)驗、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認證服務！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="上海去磁設備驗證3Q認證,3Q認證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309140263671/8260746.jpg"></div><p> 離心機3Q認證內(nèi)容包括： </p> <p> IQ內(nèi)容: 1.技術(shù)類文件確認, 2.設備儀表校準確認, 3.安裝位置和安裝環(huán)境確認, 4.部件安裝確認, 5.公用系統(tǒng)連接確認和標識確認 </p> <p> OQ內(nèi)容：1.預確認(確認安裝確認是否完成,安裝確認中出現(xiàn)的偏差是否已關(guān)閉，2.設備操作SOP是否已審批完成)，3.啟動/關(guān)閉確認，4.按鍵功能確認，5.參數(shù)設置功能確認，6.轉(zhuǎn)速確認，7.計時器比對確認，8.溫度控制功能確認，9.升/降速時間確認，10。噪聲確認，11.報警/安全功能確認 </p> <p> PQ內(nèi)容：1.根據(jù)甲方SOP運行3次 </p><p> 細胞計數(shù)儀3Q認證內(nèi)容包括： </p> <p> IQ內(nèi)容: 技術(shù)類文件確認, 設備儀表校準確認, 安裝位置和安裝環(huán)境確認, 部件安裝確認, 公用系統(tǒng)連接確認和標識確認 </p> <p> OQ內(nèi)容：預確認(確認安裝確認是否完成,安裝確認中出現(xiàn)的偏差是否已關(guān)閉，設備操作SOP是否已審批完成)，開啟/關(guān)閉確認，測量模式配置確認，校零功能確認，基本檢測功能確認，數(shù)據(jù)重新處理功能確認，打印功能確認，數(shù)據(jù)導出功能確認，斷電恢復確認 </p> <p> PQ內(nèi)容：預確認(確認運行確認是否完成，安裝運行確認中出現(xiàn)的偏差是否已關(guān)閉)，檢測流程確認，攜帶污染率確認，重復性確認旦霆科技作為專業(yè)的3Q認證、第三方檢測供應商，配備國外專業(yè)驗證及檢測儀器，數(shù)據(jù)真實、質(zhì)量可靠值得推薦!</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="上海去磁設備驗證3Q認證,3Q認證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309142753906/1736200.jpg"></div><p> 常見驗證文件并釋意 </p> <p> 3Q認證常見驗證交付物釋意如下：用戶需求（URS）：指使用方對廠房、設施、設備或其他系統(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，按照其特點來編寫驗證計劃和方案；風險評估（RA）：一種用于評估并描述系統(tǒng)、設備或工藝的關(guān)鍵方面（CQA/CPP），以確定系統(tǒng)、設備驗證的范圍和程度的方法；設計確認（DQ）：在設備建造前，對設備設計文件（用戶需求說明、功能設計說明、詳細設計說明等）進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（IQ）：為確認安裝或改造后的設施、系統(tǒng)和設備符合已批準的設計及制造商建議所作的各種查證及文件記錄，新的或改造的廠房、設施、設備需進行安裝確認；運行確認（OQ）：應當證明廠房、設施、設備的運行符合設計標準；性能確認（PQ）：性能確認目的在于證明廠房、設施、設備在正常操作方法和工藝條件下能夠持續(xù)符合標準，性能確認方案的制定應依據(jù)已有的生產(chǎn)工藝、設施和設備的相關(guān)知識，使用生產(chǎn)物料、適當?shù)奶娲坊蛘吣M產(chǎn)品來進行試驗/測試；需求追溯矩陣。旦霆科技配備數(shù)十人的驗證及檢測團隊，承接國內(nèi)各類相關(guān)企業(yè)的3Q認證、第三方驗證或檢測及咨詢服務。上海去磁設備驗證3Q認證</p><p style="text-indent:25px">旦霆科技團隊成員精通、掌握國內(nèi)為GMP、國標、ISO、ISPE等相關(guān)法規(guī)，可為相關(guān)企業(yè)開展3Q認證等服務。上海去磁設備驗證3Q認證</p><p> 二氧化碳培養(yǎng)箱3Q認證內(nèi)容包括： </p> <p> IQ內(nèi)容: 技術(shù)類文件確認, 設備儀表校準確認, 安裝位置和安裝環(huán)境確認, 部件安裝確認, 公用系統(tǒng)連接確認和標識確認 </p> <p> OQ內(nèi)容：預確認(確認安裝確認是否完成,安裝確認中出現(xiàn)的偏差是否已關(guān)閉，設備操作SOP是否已審批完成)，開啟/關(guān)閉確認，報警功能確認，數(shù)據(jù)記錄功能確認，參數(shù)校準功能確認，空載溫度分布確認，空載CO2濃度確認，斷電挑戰(zhàn)試驗 </p> <p> PQ內(nèi)容：預確認(確認運行確認是否完成，安裝運行確認中出現(xiàn)的偏差是否已關(guān)閉)，滿載溫度分布確認，滿載CO2濃度確認，開門挑戰(zhàn)試驗上海去磁設備驗證3Q認證</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、制藥設備等行業(yè)提供GXP合規(guī)咨詢、驗證服務以及培訓的綜合性咨詢公司； </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等機構(gòu)的GMP認證檢查； </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，同時公司每年利潤的10%捐獻給中國貧困兒童，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/2885269.html</p></div></div></div></div></div><div id="ncli7yv" class="page-right twoColRt"><div id="icelsu3" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="az3q3l2" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/814588.html"><div><img 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