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src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309147939453/5125649.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="7j9nhvy" 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>貴州生產(chǎn)設(shè)備3Q認證,3Q認證</p><p><span>***更新：</span>2021-01-27 04:05:22</p><p><span id="click" >瀏覽次數(shù)：1次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="zjbn3s4" 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="dheqamt" class="page-proshow02"><p class="title">詳細說明</p><div id="blspbnk" class="box"><p><p> 細胞計數(shù)儀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)，檢測流程確認，攜帶污染率確認，重復性確認 </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(shè)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，貴州生產(chǎn)設(shè)備3Q認證，數(shù)據(jù)導出功能確認，斷電恢復確認 </p> <p> IQ內(nèi)容: 技術(shù)類文件確認, 設(shè)備儀表校準確認，貴州生產(chǎn)設(shè)備3Q認證, 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> <br /> </p> <p> <br /> 旦霆科技配備數(shù)十人的驗證及檢測團隊，貴州生產(chǎn)設(shè)備3Q認證，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。貴州生產(chǎn)設(shè)備3Q認證</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="貴州生產(chǎn)設(shè)備3Q認證,3Q認證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309147939453/5125649.jpg"></div><p> 再驗證怎么做？ </p> <p> <br /> </p> <p> 3Q認證中，再驗證是指一項生產(chǎn)工藝、一個系統(tǒng)或設(shè)備、或一種原材料經(jīng)過驗證，并在使用一個階段后，旨在證實其“驗證狀態(tài)”沒有發(fā)生漂移而進行的驗證。再驗證通常由下述三個原因引起： </p> <p> 1. 藥監(jiān)部門或法規(guī)要求的強制性再驗證：如無菌操作的培養(yǎng)基灌裝試驗，計量器具的強制檢定 </p> <p> 2. 發(fā)生變更時的“改變”性再驗證：如包裝形式的改變，工藝參數(shù)或工藝路線的變更，關(guān)鍵設(shè)備變更，生產(chǎn)***變更，常規(guī)檢測表明系統(tǒng)存在著影響質(zhì)量的變遷情況； </p> <p> 3. 每隔一段時間進行的“定期”再驗證：如滅菌設(shè)備、關(guān)鍵潔凈區(qū)的空調(diào)凈化系統(tǒng)等。 </p> <p> 在下列情況下需進行再驗證： </p> <p> (1)關(guān)鍵設(shè)備大修或更換及程控設(shè)備在預定生產(chǎn)一定周期后。 </p> <p> (2)批量數(shù)量級的變更。 </p> <p> (3)趨勢分析中發(fā)現(xiàn)有系統(tǒng)性偏差。 </p> <p> (4)當影響產(chǎn)品質(zhì)量的主要因素，如工藝、質(zhì)量控制方法、主要原輔料、主要生產(chǎn)設(shè)備或主要生產(chǎn)介質(zhì)發(fā)生改變時。 </p> <p> 生產(chǎn)企業(yè)應根據(jù)自身產(chǎn)品及工藝的特點制定再驗證的周期，一般不宜超過2年。即使在設(shè)備及規(guī)程沒有任何變更的情況下，也要求定期進行再驗證。如產(chǎn)品的滅菌設(shè)備，在正常的情況下須每年作1次再驗證，又如培養(yǎng)基模擬分裝試驗每年至少2次。 </p> <p> <br /> 貴州生產(chǎn)設(shè)備3Q認證旦霆科技各類行業(yè)的驗證服務經(jīng)驗，專業(yè)為您提供3Q認證，值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="貴州生產(chǎn)設(shè)備3Q認證,3Q認證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309142753906/1736200.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(shè)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(shè)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(shè)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> 什么是驗證總結(jié)報告，怎么做？ </p> <p> <br /> </p> <p> 在3Q認證確認程序的*** 階段應完成確認總結(jié)報告。這個報告的目的是總結(jié)和**終審核所有可能存在問題的確認活動以及出現(xiàn)的偏差。確認總結(jié)報告*** ，應正式說明系統(tǒng)準予放行，可進行GMP相關(guān)的生產(chǎn)活動。滿足以下條件，本系統(tǒng)即可批準正式放行： </p> <p> 1. 所有的測試均執(zhí)行完成，所有的確認報告（DQ, CCA,RA,IQ, OQ, PQ）被批準； </p> <p> 2. 如有必要，應通過追蹤矩陣、檢查清單等方式證實所有的URS已得到滿足； </p> <p> 3. 所有的偏差均被糾正和關(guān)閉； </p> <p> 4. 如果只有微小偏差沒有關(guān)閉，只能生成一個臨時的總結(jié)報告，這種情況下可以接受該系統(tǒng)限制性放行，并可用于GMP操作。當所有偏差被關(guān)閉后，批準**終的驗證總結(jié)報告； </p> <p> 當每個系統(tǒng)驗證總結(jié)報告均被批準之后，整個項目的確認活動宣告完成，并可以投入應用于GMP相關(guān)的生產(chǎn)操作。在驗證主報告中應該描述性的總結(jié)所有相關(guān)系統(tǒng)的狀況，確保沒有遺漏任何一個GMP相關(guān)或生物安全相關(guān)的系統(tǒng) </p> <p> <br /> 旦霆科技布局細胞行業(yè)，目前為20余家相關(guān)行業(yè)的公司提供3Q認證及咨詢等服務。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="貴州生產(chǎn)設(shè)備3Q認證,3Q認證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309137695312/441838.png"></div><p> 離心機、3Q認證內(nèi)容包括： </p> <p> PQ內(nèi)容：1.根據(jù)甲方SOP運行3次 </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(shè)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(shè)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> IQ內(nèi)容: 1.技術(shù)類文件確認, 2.設(shè)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> <br /> </p> <p> <br /> 旦霆科技致力于質(zhì)量優(yōu)、人員佳、信價比高的質(zhì)量服務，為制藥行業(yè)等企業(yè)提供3Q認證，驗證及檢測服務和咨詢。甘肅酶標儀驗證3Q認證</p><p style="text-indent:25px">旦霆科技不斷強化團隊管理、品牌價值及服務升級，以質(zhì)量的理念良好的信譽為企業(yè)提供高水準的3Q認證服務！貴州生產(chǎn)設(shè)備3Q認證</p><p> 二氧化碳培養(yǎng)箱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)，滿載溫度分布確認，滿載CO2濃度確認，開門挑戰(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(shè)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> IQ內(nèi)容: 技術(shù)類文件確認, 設(shè)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> <br /> </p> <p> <br /> 貴州生產(chǎn)設(shè)備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(shè)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/3028183.html</p></div></div></div></div></div><div id="3k9u8uy" class="page-right 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