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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>湖北注射用水系統(tǒng)驗(yàn)證咨詢公司,驗(yàn)證咨詢公司</p><p><span>***更新：</span>2021-01-17 10:04:42</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="h772kh2" 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(hào)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="89lhyfc" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="mizliel" class="box"><p><p> 冷鏈運(yùn)輸系統(tǒng)驗(yàn)證 </p> <p> 旦霆科技為企業(yè)提供冷鏈運(yùn)輸系統(tǒng)GMP驗(yàn)證咨詢冷鏈運(yùn)輸倉儲(chǔ)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(yùn)輸工具和監(jiān)控儀器等系統(tǒng)驗(yàn)證，對(duì)于物流系統(tǒng)的風(fēng)險(xiǎn)評(píng)估，首先需要確定運(yùn)輸?shù)沫h(huán)境，分析運(yùn)輸過程中可能對(duì)產(chǎn)品<span style="display:none;"></span>（藥品或包材）產(chǎn)生的危害，驗(yàn)證應(yīng)重點(diǎn)考慮環(huán)境溫度變化、冷藏藥品穩(wěn) 定性數(shù)據(jù)、運(yùn) 輸或配送的相關(guān)信息、包裝部件的設(shè)計(jì)等。冷鏈運(yùn)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(dòng)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(yùn)行確認(rèn)一般在實(shí)驗(yàn)室內(nèi)完成，這些測(cè)試應(yīng)該能夠保證包裝和運(yùn)輸方案能夠維持產(chǎn)品所處的內(nèi)部環(huán)境。測(cè)試應(yīng)該包括冷點(diǎn)和熱點(diǎn)的確認(rèn)，震蕩測(cè)試，受壓測(cè)試等。一般包括以下測(cè)試項(xiàng)：安裝確認(rèn)報(bào)告以及運(yùn)行確認(rèn)方案已完成，冬季、夏季溫度曲線確認(rèn)，產(chǎn)品比較大/**小裝載/季節(jié)測(cè)試，溫度比對(duì)測(cè)試以及按照風(fēng)險(xiǎn)評(píng)估結(jié)果的其他測(cè)試項(xiàng)目；性能測(cè)試包括以下內(nèi)容：確認(rèn)安裝確認(rèn)和運(yùn)行確認(rèn)已經(jīng)完成，性能確認(rèn)方案得到批準(zhǔn)，SOP狀態(tài)應(yīng)為已批準(zhǔn)，測(cè)試儀器儀表校準(zhǔn) 確認(rèn)，典型產(chǎn)品裝載按照運(yùn) 輸路線，湖北注射用水系統(tǒng)驗(yàn)證咨詢公司、運(yùn)輸類型、運(yùn)輸季節(jié)及運(yùn)輸時(shí)間等運(yùn)輸條件確認(rèn)，溫度監(jiān)測(cè)和計(jì)算機(jī)系統(tǒng)數(shù)據(jù)備份的確認(rèn)。旦霆科技配備幾百套驗(yàn)證及檢測(cè)儀器，湖北注射用水系統(tǒng)驗(yàn)證咨詢公司，湖北注射用水系統(tǒng)驗(yàn)證咨詢公司，專業(yè)的驗(yàn)證及檢測(cè)服務(wù)團(tuán)隊(duì)，專業(yè)提供驗(yàn)證服務(wù)，服務(wù)區(qū)域覆蓋全國。湖北注射用水系統(tǒng)驗(yàn)證咨詢公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北注射用水系統(tǒng)驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431491435547/7911574.jpg"></div><p> 倉儲(chǔ)物流系統(tǒng)簡(jiǎn)介 </p> <p> 旦霆科技為企業(yè)提供倉儲(chǔ)物流系統(tǒng)GMP驗(yàn)證咨詢，制藥企業(yè) 的產(chǎn) 品通過生產(chǎn) 、存儲(chǔ) 、運(yùn) 輸及交付，**終才能到達(dá)患者的手中，為保證患者的安全，如何對(duì)制<span style="display:none;"></span>藥企業(yè) 的倉儲(chǔ) 物流系統(tǒng) 進(jìn) 行驗(yàn) 證成為關(guān) 注的重點(diǎn) 問題。ICHQ7，《美國藥典》，中國GMP2010版都對(duì)藥品的倉儲(chǔ)物流系統(tǒng)提出了相應(yīng)的法規(guī)需求。ISPE<span style="display:none;"></span>冷鏈管理中對(duì)藥品的冷鏈則提出了具體的質(zhì)量計(jì)劃，從倉儲(chǔ)運(yùn)輸做出了具體規(guī)劃： </p> <p> 1.廠房管理：包括培訓(xùn)，清潔，維護(hù)，蟲害控制以及安全； </p> <p> 2. 對(duì)以下幾類物料存儲(chǔ)條件的管理：包裝物料，印刷物料，產(chǎn)品潛在危害物質(zhì)，合格物料，待檢物料，不合格物料等，以及對(duì)物料存儲(chǔ)的存貨單控制/記錄和管理流程的建立（包括培訓(xùn)，接收和發(fā)貨）等； </p> <p> 3.對(duì)溫度受控區(qū)域的控制：規(guī)范要求，產(chǎn)品數(shù)據(jù)，相應(yīng)的清潔，維護(hù)，校準(zhǔn)，確認(rèn)，監(jiān)控，報(bào)警流程，廢料處理等， </p> <p> 4.運(yùn)輸：運(yùn)輸方法的制定和驗(yàn)證，供應(yīng) 商審計(jì)，供應(yīng) 商性能確認(rèn) / 監(jiān) 測(cè)，貨物檢測(cè) / 性能監(jiān) 測(cè)等等。湖北注射用水系統(tǒng)驗(yàn)證咨詢公司旦霆科技配備數(shù)十人的驗(yàn)證及檢測(cè)團(tuán)隊(duì)，承接國內(nèi)各類相關(guān)企業(yè)的CSV驗(yàn)證、第三方驗(yàn)證或檢測(cè)及咨詢服務(wù)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北注射用水系統(tǒng)驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431491337890/60026.jpg"></div><p> OQ(運(yùn)行確認(rèn))：其主要是驗(yàn)證儀器在空轉(zhuǎn)的情況下，在儀器設(shè)計(jì)的限度方位內(nèi)都能完成良好的運(yùn)行，也就是一個(gè)**小限和比較大限試驗(yàn)的驗(yàn)證。 </p> <p> <br /> </p> <p> 在這里需要使用到很多計(jì)量設(shè)備來確認(rèn)儀器的一些功能，比如溫度，我們需要利用一個(gè)外界的溫度設(shè)備來驗(yàn)證儀器本身設(shè)計(jì)的比較高溫度和比較低溫度，是否在設(shè)計(jì)范圍內(nèi)。 </p> <p> <br /> </p> <p> 還比如進(jìn)樣體積，如果進(jìn)樣量大可以使用已校正好的量具來確認(rèn)。如果體積較小，就需要通過間接方法來確認(rèn)，如液相的進(jìn)樣準(zhǔn)確性，可以通過標(biāo)準(zhǔn)樣品連續(xù)進(jìn)樣來確認(rèn)。 </p> <p> <br /> </p> <p> PQ(性能確認(rèn))：對(duì)于儀器而言，此步驟可以簡(jiǎn)單的理解為實(shí)際樣品的OQ(運(yùn)行確認(rèn))，因?yàn)榇瞬襟E是帶入樣品進(jìn)行試驗(yàn)的，有已知濃度的樣品，來驗(yàn)證儀器的準(zhǔn)確性。有未知濃度的樣品，來驗(yàn)證儀器檢測(cè)能力等等。 </p> <p> <br /> </p> <p> 簡(jiǎn)單的講，就是按照樣品檢測(cè)的方法檢測(cè)一遍或兩遍的過程。一般來說，IQ(安裝確認(rèn))、OQ(運(yùn)行確認(rèn))做好了，PQ(性能確認(rèn))也就能順利通過了。 </p> <p> <br /> </p><p> 什么是設(shè)計(jì)確認(rèn)，怎么做？ </p> <p> GMP驗(yàn)證咨詢服務(wù)過程中設(shè)計(jì)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(jì)適用于其預(yù)期用途和GxP的要求，用科學(xué)的理論和實(shí)際的數(shù)據(jù)證明設(shè)計(jì)結(jié)果滿足用戶需求說明。設(shè)計(jì)確認(rèn)執(zhí)行過程中可通過表格的方式對(duì)用戶需求是否在設(shè)計(jì)文件中得以實(shí)現(xiàn)進(jìn)行詳細(xì)的比對(duì)，且詳細(xì)記錄設(shè)計(jì)文件如何滿足相應(yīng)的用戶需求，并對(duì)相應(yīng)的設(shè)計(jì)文件進(jìn)行詳細(xì)索引，設(shè)計(jì)確認(rèn)過程中對(duì)于不能滿足的用戶需求應(yīng)進(jìn)行記錄，并通過評(píng)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(jí)。經(jīng)過批準(zhǔn)的設(shè)計(jì)確認(rèn)報(bào)告是后續(xù)確認(rèn)活動(dòng)（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 /> 旦霆科技布局藥企行業(yè)，目前為20余家相關(guān)行業(yè)的公司提供計(jì)算機(jī)化系統(tǒng)驗(yàn)證及咨詢等服務(wù)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北注射用水系統(tǒng)驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431491503906/5150702.png"></div><p> 什么是用戶需求，用戶需求包含什么內(nèi)容？ </p> <p> GMP驗(yàn)證咨詢服務(wù)中，用戶需求（URS）是指用戶為滿足GMP法規(guī)、工藝用途等提出的對(duì)設(shè)備及相關(guān)系統(tǒng)的要求，因此，用戶需求編制應(yīng)依據(jù)工藝規(guī)程和法規(guī)要求，其內(nèi)容包括技術(shù)、GxP、生物安全、操作安全等相關(guān)方面。用戶應(yīng)對(duì)所有用戶需求進(jìn)行編號(hào)以便追蹤，并將其分類為與GMP相關(guān)和不相關(guān)，GMP相關(guān)需求構(gòu)成確認(rèn)和驗(yàn)證的基礎(chǔ)。用戶需求編制時(shí)應(yīng)注意，文件應(yīng)描述系統(tǒng)“應(yīng)該做到的”，而不是“如何做”，用戶應(yīng)在與系統(tǒng)供應(yīng)商溝通后確定“如何做”，并將其記錄在功能設(shè)計(jì)規(guī)范和詳細(xì)設(shè)計(jì)規(guī)范中。旦霆科技針對(duì)于中大型驗(yàn)證及測(cè)試項(xiàng)目均配備項(xiàng)目經(jīng)理，在為提供3Q認(rèn)證服務(wù)時(shí)及時(shí)匯報(bào)進(jìn)、嚴(yán)格控制質(zhì)量！湖北注射用水系統(tǒng)驗(yàn)證咨詢公司</p><p style="text-indent:25px">旦霆科技不斷強(qiáng)化團(tuán)隊(duì)管理、品牌價(jià)值及服務(wù)升級(jí)，以質(zhì)量的理念為企業(yè)提供高水準(zhǔn)的CSV驗(yàn)證服務(wù)！湖北注射用水系統(tǒng)驗(yàn)證咨詢公司</p><p> 旦霆科技為企業(yè)提供倉儲(chǔ)物流系統(tǒng)GMP驗(yàn)證咨詢，。IS P E 冷鏈管理中對(duì)藥品的冷鏈則提出了具體的質(zhì)量計(jì)劃，從倉儲(chǔ)運(yùn)輸做出了具體規(guī)劃： </p> <p> 1.廠房管理：包括培訓(xùn)，清潔，維護(hù)，蟲害控制以及安全；2. 對(duì)以下幾類物料存儲(chǔ)條件的管理：包裝物料，印<span style="display:none;"></span>刷物料，產(chǎn)品潛在危害物質(zhì)，合格物料，待檢物料，不合格物料等，以及對(duì)物料存儲(chǔ)的存貨單控制 / 記錄和管理流程的建立（包括培訓(xùn)，接收和發(fā)貨）等；3.對(duì)溫度受控區(qū)域的控制：規(guī)范要求，產(chǎn)品數(shù)據(jù)，相應(yīng)的清潔，維護(hù)，校準(zhǔn)，確認(rèn)，監(jiān)控，報(bào)警流程，廢料處理等，4.運(yùn)輸：運(yùn) 輸方法的制定和驗(yàn)證，供應(yīng) 商審計(jì)，供應(yīng) 商性能確認(rèn)/ 監(jiān) 測(cè)，貨物檢測(cè) / 性能監(jiān)測(cè)等等。制藥企業(yè)的產(chǎn)品通過生產(chǎn) 、存儲(chǔ) 、運(yùn)輸及交付，**終才能到達(dá) 患者的手中，為保證患者的安全，如何對(duì)制藥企業(yè)的倉儲(chǔ)物流系統(tǒng) 進(jìn)行驗(yàn)證成為關(guān)注的重點(diǎn)問題。ICHQ7，《美國藥典》，中國GMP2010版都對(duì)藥品的倉儲(chǔ)物流系統(tǒng)提出了相應(yīng)的法規(guī)需求湖北注射用水系統(tǒng)驗(yàn)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(yàn)證服務(wù)以及培訓(xùn)的綜合性咨詢公司； </p> <p> 旦霆公司長(zhǎng)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(cè)公司。 </p> <p> 作為以慈善事業(yè)為使命的旦霆公司堅(jiān)持以超值的品質(zhì)為客戶提供服務(wù)，同時(shí)公司每年利潤(rùn)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/2887232.html</p></div></div></div></div></div><div id="e3d8ugs" class="page-right twoColRt"><div id="oaxpg8a" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="2nevxjq" 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="2lxeq7s" 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