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發(fā)信息做推廣就找產(chǎn)品網(wǎng)<br />企業(yè)電商信息綜合服務(wù)平臺(tái) </span><div id="l33tn3p" class="searchbox"><div id="lnndbjx" class="searchLt"><div id="zrzhft3" class="tabs"><a href="JavaScript:;" data-type="product" class="active">產(chǎn)品</a><a href="JavaScript:;" data-type="member" class="">公司</a><a href="JavaScript:;" data-type="article" class="">資訊</a><a href="JavaScript:;" data-type="exhibition" class="">展會(huì)</a></div><div id="fb5djzv" class="clearfix searchWrap"><div id="bbpjpnr" class="searchInput"><input type="text" name="keywords" placeholder="請(qǐng)輸入搜索關(guān)鍵詞" id="kd"><a href="javascript:void(0)" class="searchBtn" id="search">搜索</a></div></div></div></div></header><nav class="navbox"><div id="vdlb7lh" class="container"><ul><li id = "index_index"><a href="http://www.cdcfah.com/"><span>首頁(yè)</span></a></li><li id = "index_company"><a ><span>企業(yè)名錄</span></a></li><li id = "index_product"><a href="http://www.cdcfah.com/cp/"><span>產(chǎn)品供應(yīng)</span></a></li><li id = 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id="5hlbxv5" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431525859375/4595948.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="jvlhxdr" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431525859375/4595948.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="5bzfvbh" 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>廣東手術(shù)室驗(yàn)證咨詢(xún)公司,驗(yàn)證咨詢(xún)公司</p><p><span>***更新：</span>2021-01-15 03:04:51</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="3jp3bxl" 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(huà): </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(xiàn)] <a rel="nofollow"> [加為商友] </a><a rel="nofollow"> [發(fā)送信件] </a></p></div></div><div id="3bpfdth" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="prpvlrp" class="box"><p><p> 什么是風(fēng)險(xiǎn)評(píng)估，怎么做？ </p> <p> GMP驗(yàn)證咨詢(xún)服務(wù)過(guò)程中風(fēng)險(xiǎn)評(píng)估是為了簡(jiǎn)化驗(yàn)證和減少不必要的確認(rèn)活動(dòng)，應(yīng)通過(guò)風(fēng)險(xiǎn)評(píng)估的方法確定待確認(rèn)的設(shè)備或系統(tǒng)以及每個(gè)系統(tǒng)所需要的驗(yàn)證范圍和程度。風(fēng)險(xiǎn)評(píng)估是一種用于評(píng)估并描述系統(tǒng)、設(shè)備或工藝的關(guān)鍵方面，以構(gòu)成編寫(xiě)驗(yàn)證方案的基礎(chǔ)的方法。在定義關(guān)鍵設(shè)計(jì)控制(CAs/CDEs)后，采用失效模式影響分析（Failure mode effects analysis，廣東手術(shù)室驗(yàn)證咨詢(xún)公司, FMEA)或其他風(fēng)險(xiǎn)評(píng)估工具來(lái)找出可能失效的影響。風(fēng)險(xiǎn)評(píng)估結(jié)果以表格形式提供，每一行分別對(duì)應(yīng)一個(gè)需求或功能可能失效的風(fēng)險(xiǎn)，每個(gè)風(fēng)險(xiǎn)具有對(duì)應(yīng)編號(hào)。在表格中應(yīng)結(jié)合URS要求，以及設(shè)計(jì)確認(rèn)結(jié)果列出關(guān)鍵設(shè)計(jì)控制(CAs/CDEs)所有失效模式，廣東手術(shù)室驗(yàn)證咨詢(xún)公司，并分析其失效的可能性，危害嚴(yán)重性以及失效的可檢測(cè)性，將失效模式分為高中低三級(jí)，并制定相應(yīng)的風(fēng)險(xiǎn)降低策略。風(fēng)險(xiǎn)降低策略可包含驗(yàn)證策略的提出，制作針對(duì)系統(tǒng)的檢查表，制定相應(yīng)的SOP（如設(shè)備/儀器操作，人員管理，對(duì)關(guān)鍵功能模塊進(jìn)行定期維護(hù)，定期再驗(yàn)證等），廣東手術(shù)室驗(yàn)證咨詢(xún)公司。 </p> <p> <br /> 旦霆科技作為專(zhuān)業(yè)驗(yàn)證檢測(cè)供應(yīng)商，具備CMA資質(zhì)，專(zhuān)業(yè)提供CSV驗(yàn)服務(wù)，是您放心的選擇！廣東手術(shù)室驗(yàn)證咨詢(xún)公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="廣東手術(shù)室驗(yàn)證咨詢(xún)公司,驗(yàn)證咨詢(xún)公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431525859375/4595948.jpg"></div><p> 旦霆科技為企業(yè)提供制藥用水系統(tǒng)GMP驗(yàn)證咨詢(xún)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(lèi)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),機(jī)械部件安裝確認(rèn)，HMI及PLC確認(rèn)，標(biāo)識(shí)確認(rèn)，I/O測(cè)試確認(rèn)；OQ內(nèi)容包括：系統(tǒng)啟動(dòng)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(hù)權(quán)限確認(rèn)，控制柜急停功能確認(rèn)，電機(jī)轉(zhuǎn)向確認(rèn)，罐體排空確認(rèn)，核黃素覆蓋率確認(rèn)，預(yù)處理清洗、消毒功能確認(rèn)，軟化器自動(dòng)再生功能確認(rèn)，反滲透自動(dòng)沖洗功能確認(rèn)，自動(dòng)程序運(yùn)行確認(rèn)，純化水流速及產(chǎn)能確認(rèn)，電加熱空氣呼吸器（保溫純化水箱）加熱功能確認(rèn)，紫外滅菌器計(jì)時(shí)功能確認(rèn)，反滲透系統(tǒng)消毒功能確認(rèn)，純化水分配系統(tǒng)消毒功能確認(rèn)，純化水關(guān)鍵控制點(diǎn)取樣確認(rèn)，用戶(hù)權(quán)限確認(rèn)，互鎖/安全確認(rèn)，報(bào)警確認(rèn)，斷電恢復(fù)確認(rèn)，數(shù)據(jù)打印功能確認(rèn)；PQ內(nèi)容包括：第1階段（評(píng)價(jià)階段），第2階段（短期質(zhì)量控制階段）驗(yàn)證交付物包括VP，SC，SRA，IQ，OQ，PQ，RTM以及VSR文件。廣東手術(shù)室驗(yàn)證咨詢(xún)公司旦霆科技成員具備多年工作經(jīng)驗(yàn)、良好的GMP理念、熟悉精通國(guó)內(nèi)外相關(guān)法規(guī)，可專(zhuān)業(yè)開(kāi)展CSV驗(yàn)證服務(wù)！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="廣東手術(shù)室驗(yàn)證咨詢(xún)公司,驗(yàn)證咨詢(xún)公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431491503906/5150702.png"></div><p> 再驗(yàn)證怎么做? </p> <p> GMP驗(yàn)證咨詢(xún)服務(wù)中，再驗(yàn)證是指一項(xiàng)生產(chǎn)工藝、一個(gè)系統(tǒng)或設(shè)備、或一種原材料經(jīng)過(guò)驗(yàn)證，并在使用一個(gè)階段后，旨在證實(shí)其“驗(yàn)證狀態(tài)”沒(méi)有發(fā)生漂移而進(jìn)行的驗(yàn)證。再驗(yàn)證通常由下述三個(gè)原因引起： </p> <p> 1. 藥監(jiān)部門(mén)或法規(guī)要求的強(qiáng)制性再驗(yàn)證：如無(wú)菌操作的培養(yǎng)基灌裝試驗(yàn)，計(jì)量器具的強(qiáng)制檢定 </p> <p> 2. 發(fā)生變更時(shí)的“改變”性再驗(yàn)證：如包裝形式的改變，工藝參數(shù)或工藝路線(xiàn)的變更，關(guān)鍵設(shè)備變更，生產(chǎn)***變更，常規(guī)檢測(cè)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(shí)間進(jìn)行的“定期”再驗(yàn)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(jìn)行再驗(yàn)證： </p> <p> (1)關(guān)鍵設(shè)備大修或更換及程控設(shè)備在預(yù)定生產(chǎn)一定周期后。 </p> <p> (2)批量數(shù)量級(jí)的變更。 </p> <p> (3)趨勢(shì)分析中發(fā)現(xiàn)有系統(tǒng)性偏差。 </p> <p> (4)當(dāng)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(shí)。 </p> <p> 生產(chǎn)企業(yè)應(yīng)根據(jù)自身產(chǎn)品及工藝的特點(diǎn)制定再驗(yàn)證的周期，一般不宜超過(guò)2年。即使在設(shè)備及規(guī)程沒(méi)有任何變更的情況下，也要求定期進(jìn)行再驗(yàn)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(yàn)證，又如培養(yǎng)基模擬分裝試驗(yàn)每年至少2次。 </p> <p> <br /> </p> <p> </p> <p> <br /> </p> <p> </p><p> 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(lèi)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(shí)確認(rèn)以及I/O測(cè)試確認(rèn)，OQ內(nèi)容包括：系統(tǒng)啟動(dòng)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(hù)權(quán)限確認(rèn)，報(bào)警確認(rèn)，斷電恢復(fù)確認(rèn)，自動(dòng)運(yùn)行確認(rèn)，風(fēng)量及換氣次數(shù)確認(rèn)測(cè)，壓差確認(rèn)，高效過(guò)濾器及邊框完整性確認(rèn)，溫度/相對(duì)濕度確，噪音確認(rèn)測(cè)，照度確認(rèn)，氣流流型確認(rèn)，自?xún)魰r(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(duì)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(cè)試以及表面微生物，動(dòng)態(tài)執(zhí)行三次。<span style="display:none;"></span> 旦霆科技以高質(zhì)量作為服務(wù)宗旨，為國(guó)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(xún)服務(wù)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="廣東手術(shù)室驗(yàn)證咨詢(xún)公司,驗(yàn)證咨詢(xún)公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431512939453/2814885.jpg"></div><p> 什么是需求追溯矩陣，怎么做？ </p> <p> ISPE </p> <p> GAMP5《良好自動(dòng)化生產(chǎn)實(shí)踐指南-遵從GxP計(jì)算機(jī)化系統(tǒng)監(jiān)管的風(fēng)險(xiǎn)管理方法》提到：在系統(tǒng)生命周期的早期就應(yīng)該識(shí)別并糾正系統(tǒng)缺點(diǎn)，設(shè)計(jì)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(guò)在早期識(shí)別缺點(diǎn)并解決問(wèn)題來(lái)降低總體項(xiàng)目成本?！盙MP驗(yàn)證咨詢(xún)服務(wù)過(guò)程中，需求追溯性矩陣（Requirements </p> <p> traceability matrix, RTM)可與標(biāo)準(zhǔn)、要點(diǎn)和成果進(jìn)行比較，對(duì)特定問(wèn)題點(diǎn)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(jì)需求經(jīng)過(guò)了驗(yàn)證，并可以追溯到表明需求得到滿(mǎn)足的測(cè)試或驗(yàn)證活動(dòng)； </p> <p> 2.使得風(fēng)險(xiǎn)管理和設(shè)計(jì)審査流程更有效率； </p> <p> 判斷所提交的變更需求會(huì)產(chǎn)生什么樣的影響； </p> <p> 3.有助于對(duì)所提交的變更進(jìn)行風(fēng)險(xiǎn)評(píng)估； </p> <p> 4.確認(rèn)對(duì)變更進(jìn)行測(cè)試的范圍； </p> <p> 5.可在檢査和審査時(shí)快速準(zhǔn)確地反應(yīng)。旦霆科技提供技術(shù)咨詢(xún)、3Q認(rèn)證、驗(yàn)證及檢測(cè)服務(wù)。在您不知道具體項(xiàng)目需求時(shí)為您擇優(yōu)推薦！廣東手術(shù)室驗(yàn)證咨詢(xún)公司</p><p style="text-indent:25px">旦霆科技擁有先進(jìn)的驗(yàn)證理念，成熟的驗(yàn)證體系，完善的質(zhì)量體系，為您提供專(zhuān)業(yè)、質(zhì)量的CSV認(rèn)證服務(wù)！廣東手術(shù)室驗(yàn)證咨詢(xún)公司</p><p style="text-indent:25px">目前全球加工產(chǎn)業(yè)發(fā)展主要有美國(guó)波士頓—?jiǎng)虻尼t(yī)藥產(chǎn)業(yè)集聚區(qū)、德國(guó)圖特林根的醫(yī)藥產(chǎn)業(yè)集聚區(qū)、日本富山縣的醫(yī)藥產(chǎn)業(yè)集聚區(qū)、印度班加羅爾的仿制藥產(chǎn)業(yè)集聚區(qū)等九大發(fā)展模式。而我國(guó)仍以醫(yī)藥服務(wù)和醫(yī)藥商品為主，整體收入規(guī)模偏小。在項(xiàng)目的加入上可以進(jìn)行分?jǐn)?，每一家集團(tuán)的資本壓力都會(huì)得到較大的減輕，這種具有組合資本優(yōu)勢(shì)的服務(wù)型項(xiàng)目也是很多資本重點(diǎn)關(guān)注的資本項(xiàng)目。一體化的結(jié)構(gòu)體系難以形成，我國(guó)醫(yī)藥、保養(yǎng)正處于初級(jí)發(fā)展階段，與體系健全的發(fā)達(dá)地區(qū)相比，冷鏈物流行業(yè)呈現(xiàn)規(guī)模小且分布雜亂的現(xiàn)象。醫(yī)藥行業(yè)上下游未整體規(guī)劃，成為我國(guó)冷鏈物流發(fā)展的障礙，從而使得醫(yī)藥冷鏈物流流通效率低下。首先，完善促進(jìn)GMP驗(yàn)證咨詢(xún)與服務(wù)，計(jì)算機(jī)化系統(tǒng)驗(yàn)證，壓縮空氣檢測(cè)，潔凈室檢測(cè)發(fā)展的相關(guān)政策，優(yōu)化產(chǎn)業(yè)發(fā)展環(huán)境。第二，加大對(duì)大健康前沿領(lǐng)域支持，技術(shù)帶領(lǐng)健康科技發(fā)展。第三，消滅體制機(jī)制障礙，催生更多GMP驗(yàn)證咨詢(xún)與服務(wù)，計(jì)算機(jī)化系統(tǒng)驗(yàn)證，壓縮空氣檢測(cè)，潔凈室檢測(cè)發(fā)展模式。第四，大力發(fā)展與GMP驗(yàn)證咨詢(xún)與服務(wù)，計(jì)算機(jī)化系統(tǒng)驗(yàn)證，壓縮空氣檢測(cè)，潔凈室檢測(cè)相適應(yīng)的高等教育事業(yè)。廣東手術(shù)室驗(yàn)證咨詢(xún)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(xún)、驗(yàn)證服務(wù)以及培訓(xùn)的綜合性咨詢(xún)公司； </p> <p> 旦霆公司長(zhǎng)期致力于幫助企業(yè)順利通過(guò)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(lái)自于**外資制藥企業(yè)、外資GMP咨詢(xún)公司、及國(guó)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(hù)提供服務(wù)，同時(shí)公司每年利潤(rùn)的10%捐獻(xiàn)給中國(guó)貧困兒童，持久資助中國(guó)貧困兒童的教育。 </p></p><br /><p>文章來(lái)源地址: http://www.cdcfah.com/cp/2850551.html</p></div></div></div></div></div><div id="jlb5jhh" class="page-right twoColRt"><div id="zpn5dtz" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="pndjpvt" 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) 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