安徽2-8度冷庫驗證GMP咨詢誠信為本旦霆生物科技供應(yīng)-b2b網(wǎng)站_b2b電子商務(wù)平臺【買產(chǎn)品】-上?？谄蚴称酚邢薰?/title><meta name="description" content="什么是需求追溯矩陣，安徽2-8度冷庫驗證GMP咨詢，怎么做？ISPEGAMP5《良好自動化生產(chǎn)實踐指南-遵從GxP計算機(jī)化系統(tǒng)監(jiān)管的風(fēng)險管理方法》提到：在系統(tǒng)生命周期的早期就應(yīng)該識別并糾正系統(tǒng)缺點，設(shè)計審査和可追溯性有助于保證系統(tǒng)符合預(yù)定用"><meta name="keywords" content="安徽2-8度冷庫驗證GMP咨詢,GMP咨詢"><link rel="canonical" href="http://www.cdcfah.com/"/><meta name="applicable-device" content="pc"><link rel="shortcut icon" href="/static/new_net_01/images/favicon.ico"><link rel="stylesheet" href="/static/new_net_01/css/slick.css" /><link rel="stylesheet" href="/static/new_net_01/css/addnew.css"><link rel="stylesheet" href="/static/new_net_01/css/sidenav.css"><link rel="stylesheet" href="/static/new_net_01/css/style.css" /><link rel="stylesheet" href="/static/new_net_01/css/tab.css"><link rel="stylesheet" href="/static/new_net_01/css/404.css"> <meta name="baidu-site-verification" content="OBVzrC9aaQ" /> <meta 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clearfix"><h1>安徽2-8度冷庫驗證GMP咨詢誠信為本旦霆生物科技供應(yīng)</h1><div id="qmt88bp" class="proBig"><div id="8qho2up" class="bigimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175311839003906/3223283.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="ywtamab" class="smallimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175311839003906/3223283.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="drdfgu3" 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2-8度冷庫驗證GMP咨詢,GMP咨詢</p><p><span>***更新：</span>2021-01-17 09:04:38</p><p><span id="click" >瀏覽次數(shù)：2次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="g3pmtah" 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="2bbbnul" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="8e8dzfg" class="box"><p><p> 什么是需求追溯矩陣，安徽2-8度冷庫驗證GMP咨詢，怎么做？ </p> <p> <br /> </p> <p> ISPE GAMP5《良好自動化生產(chǎn)實踐指南-遵從GxP計算機(jī)化系統(tǒng)監(jiān)管的風(fēng)險管理方法》提到：在系統(tǒng)生命周期的早期就應(yīng)該識別并糾正系統(tǒng)缺點，設(shè)計審査和可追溯性有助于保證系統(tǒng)符合預(yù)定用途，并且可以通過在早期識別缺陷并解決問題來降低總體項目成本?！?GMP咨詢過程中，需求追溯性矩陣（Requirements traceability matrix, RTM)可與標(biāo)準(zhǔn)、要點和成果進(jìn)行比較，對特定問題點提出必要的糾正措施。 </p> <p> 需求追溯矩陣可起到如下作用： </p> <p> 1.設(shè)計需求經(jīng)過了驗證，并可以追溯到表明需求得到滿足的測試或驗證活動； </p> <p> 2.使得風(fēng)險管理和設(shè)計審査流程更有效率； </p> <p> 判斷所提交的變更需求會產(chǎn)生什么樣的影響； </p> <p> 3.有助于對所提交的變更進(jìn)行風(fēng)險評估； </p> <p> 4，安徽2-8度冷庫驗證GMP咨詢.確認(rèn)對變更進(jìn)行測試的范圍； </p> <p> 5，安徽2-8度冷庫驗證GMP咨詢.可在檢査和審査時快速準(zhǔn)確地反應(yīng)。 </p> <p> <br /> 旦霆科技在提供高質(zhì)量服務(wù)的同時為眾多客戶解決項目偏差等問題。以保證GMP咨詢服務(wù)的順利進(jìn)行。安徽2-8度冷庫驗證GMP咨詢</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽2-8度冷庫驗證GMP咨詢,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175311839003906/3223283.jpg"></div><p> 冷鏈運輸系統(tǒng)驗證 </p> <p> 旦霆科技為企業(yè)提供冷鏈運輸系統(tǒng)GMP咨詢冷鏈運輸倉儲物流系統(tǒng)中一般確定為直接影響系統(tǒng)的有：庫房、設(shè) 施、設(shè) 備、保溫包裝、運輸工具和監(jiān)控儀器等系統(tǒng)驗證，對于物流系統(tǒng)的風(fēng)險評估，首先需要確定運輸的環(huán)境，分析運輸過程中可能對產(chǎn) 品（藥品或包材）產(chǎn)生的危害，驗證應(yīng)重點考慮環(huán)境溫度變化、冷藏藥品穩(wěn) 定性數(shù)據(jù)、運輸或配送的相關(guān)信息、包裝部件的設(shè)計等。冷鏈運輸車的安裝確認(rèn)主要是冷藏車的確認(rèn)，包括制冷系統(tǒng)的安裝，自動控制系統(tǒng)的安裝，以及設(shè)備狀態(tài)及關(guān)鍵儀表的校準(zhǔn)狀態(tài)的確認(rèn)；運行確認(rèn)一般在實驗室內(nèi) 完成，這些測試應(yīng)該能夠保證包裝和運輸方案能夠維持產(chǎn)品所處的內(nèi)部環(huán)境。測試應(yīng)該包括冷點和熱點的確認(rèn)，震蕩測試，受壓測試等。一般包括以下測試項：安裝確認(rèn) 報告以及運行確認(rèn)方案已完成，冬季、夏季溫度曲線確認(rèn)，模擬時間曲線（物流流線圖）確認(rèn)，產(chǎn) 品比較大 /**小裝載/季節(jié)測試，溫度比對測試以及按照風(fēng)險評估結(jié)果的其他測試項目；性能測試包括以下內(nèi)容：確認(rèn)安裝確認(rèn)和運行確認(rèn)已經(jīng)完成，性能確認(rèn)方案得到批準(zhǔn)，測試儀器儀表校準(zhǔn) 確認(rèn)，典型產(chǎn)品裝載按照運輸路線運輸類型、運輸季節(jié)及運輸時間等運輸條件確認(rèn)，溫度監(jiān)測和計算機(jī)系統(tǒng)數(shù)據(jù)備份的確認(rèn)。安徽2-8度冷庫驗證GMP咨詢旦霆科技專業(yè)提供計算機(jī)化系統(tǒng)驗證、空調(diào)系統(tǒng)及潔凈室驗證、生產(chǎn)設(shè)備驗證、GMP咨詢等驗證咨詢與服務(wù)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽2-8度冷庫驗證GMP咨詢,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312262080078/3685544.jpg"></div><p> 什么是安裝確認(rèn)，怎么做？ </p> <p> <p> GMP咨詢過程中安裝確認(rèn)方案將確認(rèn)設(shè)備/系統(tǒng)硬件和軟件是根據(jù)已批準(zhǔn)的規(guī)范安裝并記錄的，且安裝確認(rèn)部分應(yīng)描述并記錄設(shè)備/系統(tǒng)部件以及安裝環(huán)境，這樣如有需要，可以通過安裝確認(rèn)的內(nèi)容重新安裝設(shè)備/系統(tǒng)。 </p> <p> 安裝確認(rèn)中包含如下測試內(nèi)容：文件確認(rèn)（包括圖紙確認(rèn)，技術(shù)文件確認(rèn)，材質(zhì)證明確認(rèn)，施工記錄/報告確認(rèn)），儀器儀表校準(zhǔn)確認(rèn)，圖紙確認(rèn)，硬件/部件安裝確認(rèn)，安裝環(huán)境確認(rèn)，公用系統(tǒng)連接確認(rèn)，標(biāo)識確認(rèn)，I/O測試確認(rèn) </p> </p><p> 前驗證怎么做？ </p> <p> <br /> </p> <p> 新品、新型設(shè)備及其生產(chǎn)工藝的引入應(yīng)采用前驗證的方式。GMP咨詢中前驗證的目標(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> 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 /> 旦霆科技擁有幾百套進(jìn)口及國產(chǎn)測試驗證儀器，提供專業(yè)GMP咨詢、其他驗證及檢測服務(wù)，保證設(shè)備充足！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽2-8度冷庫驗證GMP咨詢,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312263828125/6888947.jpg"></div><p> 什么是驗證總結(jié)報告，怎么做？ </p> <p> <br /> </p> <p> GMP咨詢確認(rèn)程序的***階段應(yīng)完成確認(rèn)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(rèn)活動以及出現(xiàn)的偏差。確認(rèn)總結(jié)報告***，應(yīng)正式說明系統(tǒng)準(zhǔn)予放行，可進(jìn)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(zhǔn)正式放行： </p> <p> 1. 所有的測試均執(zhí)行完成，所有的確認(rèn)報告（DQ, CCA,RA,IQ, OQ, PQ）被批準(zhǔn)； </p> <p> 2. 如有必要，應(yīng)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(dāng)所有偏差被關(guān)閉后，批準(zhǔn)**終的驗證總結(jié)報告； </p> <p> 當(dāng)每個系統(tǒng)驗證總結(jié)報告均被批準(zhǔn)之后，整個項目的確認(rèn)活動宣告完成，并可以投入應(yīng)用于GMP相關(guān)的生產(chǎn)操作。在驗證主報告中應(yīng)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 /> 旦霆科技擁有專業(yè)的驗證團(tuán)隊，專業(yè)的驗證設(shè)備，為您提供專業(yè)、質(zhì)量的GMP咨詢服務(wù)！安徽2-8度冷庫驗證GMP咨詢</p><p style="text-indent:25px">旦霆科技服務(wù)面向全國、GMP咨詢及其他項目均安排項目經(jīng)理，對項目質(zhì)量、進(jìn)度及時監(jiān)督。保證項目質(zhì)量！安徽2-8度冷庫驗證GMP咨詢</p><p> 同步驗證怎么做？ </p> <p> GMP咨詢中，同步驗證是在工藝常規(guī)運行的同時進(jìn)行的驗證，即從工藝實際運行過程中獲得的數(shù)據(jù)來確立文件的依據(jù)，以證明某項工藝達(dá)到預(yù)計要求的活動。以水系統(tǒng)驗證為例，人們很難制造一個原水污染變化的環(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)運行參數(shù)的調(diào)控范圍，這種條件下，同步驗證成了合理的選擇。這種情況下，工藝驗證的實際概念是特殊監(jiān)控條件下的試生產(chǎn)，而在試生產(chǎn)性的工藝驗證過程中，可以同時獲得兩方面的結(jié)果：一是合格的產(chǎn)品，二是驗證的結(jié)果，即“工藝重現(xiàn)性及可靠性”的證據(jù)。由于同步驗證與生產(chǎn)同時進(jìn)行，因此該驗證方式可能帶來產(chǎn)品質(zhì)量方面的風(fēng)險，因此，企業(yè)應(yīng)根據(jù)自己的實際情況作出適當(dāng)?shù)倪x擇，且在制定驗證方案并實施驗證時，特別注意這種方式的先決條件，分析主客觀的情況并預(yù)計驗證結(jié)果對保證質(zhì)量可靠性的風(fēng)險程度。安徽2-8度冷庫驗證GMP咨詢</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/2886333.html</p></div></div></div></div></div><div id="lipw3r7" class="page-right twoColRt"><div id="bpwdpgs" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="qkbnugn" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/814588.html"><div><img src="http://tyunfile.71360.com/UpLoadFile/2019/11/1/14/637082168864691056_lgpj_5374157.jpg" alt="福建ZF配件哪家強(qiáng) 信息推薦自業(yè)物資供應(yīng)" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></div><p>福建ZF配件哪家強(qiáng) 信息推薦自業(yè)物資供應(yīng)</p></a></div><div id="d3st2of" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/846569.html"><div><img src="https://tyunfile.71360.com/WaterMark/UploadFile/nbzxsw/637298235378037109/764794.png" alt="寧波寧海直接考A2有幾個科目真誠推薦寧波助學(xué)商務(wù)信息咨詢供應(yīng)" class="vcenter" 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