河北區(qū)計(jì)算機(jī)驗(yàn)證第三方檢測(cè) 值得信賴旦霆生物科技供應(yīng)-b2b網(wǎng)站_b2b電子商務(wù)平臺(tái)【買產(chǎn)品】-上?？谄蚴称酚邢薰?/title><meta name="description" content="生物學(xué)測(cè)定方法驗(yàn)證旦霆科技為企業(yè)提供生物制品生物學(xué)分析方法GMP驗(yàn)證咨詢，生物學(xué)測(cè)定方法依賴于生物基質(zhì)（如動(dòng)物、活細(xì)胞或目標(biāo)受體的功能復(fù)合體等）通常比化學(xué)實(shí)驗(yàn)變異性更大，主要的是生物活性（或效價(jià)、效力）測(cè)定。生物活性測(cè)定包括以下方法：1.動(dòng)"><meta name="keywords" content="河北區(qū)計(jì)算機(jī)驗(yàn)證第三方檢測(cè),計(jì)算機(jī)驗(yàn)證"><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" 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onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="329uqse" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174846131826172/197945.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="enpmjfm" 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>河北區(qū)計(jì)算機(jī)驗(yàn)證第三方檢測(cè),計(jì)算機(jī)驗(yàn)證</p><p><span>***更新：</span>2020-08-18 01:13:29</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="qurolsu" 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="gf7b7yf" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="oskh8mo" class="box"><p><p> 生物學(xué)測(cè)定方法驗(yàn)證 </p> <p> 旦霆科技為企業(yè)提供生物制品生物學(xué)分析方法GMP驗(yàn)證咨詢，生物學(xué)測(cè)定方法依賴于生物基質(zhì)（如動(dòng)物、活細(xì)胞或目標(biāo)受體的功能復(fù)合體等）通常比化學(xué)實(shí)驗(yàn)變異性更大，主要的是生物活性（或效價(jià)、效力）測(cè)定。生物活性測(cè)定包括以下方法： </p> <p> 1.動(dòng)物試驗(yàn)方法，2.在細(xì)胞水平上測(cè)定產(chǎn)品的生化和生理效應(yīng)的細(xì)胞培養(yǎng)檢測(cè)方法；3.利用酶反應(yīng)速率或免疫相互作用誘導(dǎo)的生物反應(yīng)等方法測(cè)定生物活性的生化檢測(cè)方法。依照方法來源不同，驗(yàn)證的要求有所不同，標(biāo)準(zhǔn)方法）通常認(rèn)為在被確定為標(biāo)準(zhǔn)方法前巳經(jīng)過驗(yàn)證，使用者在采用此類方法前只需證明實(shí)際使用條件下方法的適用性，河北區(qū)計(jì)算機(jī)驗(yàn)證第三方檢測(cè)，對(duì)于非標(biāo)準(zhǔn)的方法通常需要經(jīng)過嚴(yán)格驗(yàn)證。一般情況下，需驗(yàn)證的分析項(xiàng)有：鑒別試驗(yàn)、純度和雜質(zhì)檢査，河北區(qū)計(jì)算機(jī)驗(yàn)證第三方檢測(cè)、原液或制劑中有效成分的含量測(cè)定及生物活性測(cè)定，河北區(qū)計(jì)算機(jī)驗(yàn)證第三方檢測(cè)。 </p> <p> <br /> 旦霆科技年度營(yíng)業(yè)額以50%的速度高速增長(zhǎng)，逐漸成為為數(shù)不多的中大型CSV驗(yàn)證測(cè)試服務(wù)的綜合性公司。河北區(qū)計(jì)算機(jī)驗(yàn)證第三方檢測(cè)</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北區(qū)計(jì)算機(jī)驗(yàn)證第三方檢測(cè),計(jì)算機(jī)驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174846131826172/197945.jpg"></div><p> 再驗(yàn)證怎么做? </p> <p> GMP驗(yàn)證咨詢服務(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)部門或法規(guī)要求的強(qiáng)制性再驗(yàn)證：如無菌操作的培養(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(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> <br /> 河北區(qū)ELN系統(tǒng)計(jì)算機(jī)驗(yàn)證旦霆科技提供技術(shù)咨詢、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！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北區(qū)計(jì)算機(jī)驗(yàn)證第三方檢測(cè),計(jì)算機(jī)驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174843361640625/3264996.jpg"></div><p> 什么是驗(yàn)證總結(jié)報(bào)告，怎么做？ </p> <p> <br /> </p> <p> 在GMP驗(yàn)證咨詢服務(wù)確認(rèn)程序的** 后階段應(yīng)完成確認(rèn)總結(jié)報(bào)告。這個(gè)報(bào)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(dòng)以及出現(xiàn)的偏差。確認(rèn)總結(jié)報(bào)告** 后，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(dòng)。滿足以下條件，本系統(tǒng)即可批準(zhǔn)正式放行： </p> <p> <br /> </p> <p> 1. 所有的測(cè)試均執(zhí)行完成，所有的確認(rèn)報(bào)告（DQ, CCA,RA,IQ, OQ, PQ）被批準(zhǔn)； </p> <p> <br /> </p> <p> 2. 如有必要，應(yīng)通過追蹤矩陣、檢查清單等方式證實(shí)所有的URS已得到滿足； </p> <p> <br /> </p> <p> 3. 所有的偏差均被糾正和關(guān)閉； </p> <p> <br /> </p> <p> 4. 如果只有微小偏差沒有關(guān)閉，只能生成一個(gè)臨時(shí)的總結(jié)報(bào)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(yàn)證總結(jié)報(bào)告； </p> <p> <br /> </p> <p> 當(dāng)每個(gè)系統(tǒng)驗(yàn)證總結(jié)報(bào)告均被批準(zhǔn)之后，整個(gè)項(xiàng)目的確認(rèn)活動(dòng)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(yàn)證主報(bào)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(gè)GMP相關(guān)或生物安全相關(guān)的系統(tǒng) </p> <p> <br /> </p> <p> <br /> </p> <p> <br /> </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)，自凈時(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。 </p> <p> 旦霆科技為企業(yè)提供空調(diào)系統(tǒng)與潔凈廠房GMP驗(yàn)證咨詢旦霆科技擁有先進(jìn)的驗(yàn)證理念，成熟的驗(yàn)證體系，為您提供專業(yè)、質(zhì)量的計(jì)算機(jī)化系統(tǒng)驗(yàn)證服務(wù)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北區(qū)計(jì)算機(jī)驗(yàn)證第三方檢測(cè),計(jì)算機(jī)驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637174842073759766/2128846.jpg"></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。 </p> <p> <br /> 旦霆科技可與客戶開展遠(yuǎn)程技術(shù)交流，解決難題為雙方良好合作打下扎實(shí)基礎(chǔ)，提供csv驗(yàn)證等技術(shù)服務(wù)。河北區(qū)計(jì)算機(jī)驗(yàn)證第三方檢測(cè)</p><p style="text-indent:25px">著眼質(zhì)量，靜思細(xì)量，旦霆科技為您提供專業(yè)的計(jì)算機(jī)化系統(tǒng)驗(yàn)證服務(wù)，為您的合規(guī)之路保駕護(hù)航！河北區(qū)計(jì)算機(jī)驗(yàn)證第三方檢測(cè)</p><p> 驗(yàn)證分類（名詞解釋） </p> <p> 驗(yàn)證基本分為三大類：前驗(yàn)證（Prospective Validation），回顧性驗(yàn)證（Retrospective Validation），再驗(yàn)證（Revalidation）和同步驗(yàn)證（Concurrent Validation），每種類型的驗(yàn)證活動(dòng)均有其特定的適用條件，通常情況下，甲方由于驗(yàn)證人員不足，驗(yàn)證合規(guī)理念缺失等多種原因，會(huì)尋找專業(yè)驗(yàn)證咨詢公司提供GMP驗(yàn)證咨詢服務(wù)。 </p> <p> 前驗(yàn)證：指在設(shè)備/系統(tǒng)/工藝在投入使用前必須完成并達(dá)到設(shè)定要求的驗(yàn)證，通常用于產(chǎn)品要求高，但是沒有歷史資料或缺乏歷史資料，靠生產(chǎn)控制及成品檢查不足以確保重現(xiàn)性及產(chǎn)品質(zhì)量的生產(chǎn)工藝或過程 </p> <p> 回顧性驗(yàn)證系指以歷史數(shù)據(jù)的統(tǒng)計(jì)分析為基礎(chǔ)，旨在證實(shí)正常生產(chǎn)的工藝條件適用性的驗(yàn)證。 </p> <p> 再驗(yàn)證系指對(duì)產(chǎn)品已經(jīng)驗(yàn)證過后的生產(chǎn)工藝，關(guān)鍵設(shè)施及設(shè)備、系統(tǒng)或物料在生產(chǎn)一定周期后進(jìn)行的重復(fù)驗(yàn)證， </p> <p> 同步驗(yàn)證：是指生產(chǎn)中在某項(xiàng)工藝運(yùn)行的同時(shí)進(jìn)行的驗(yàn)證，用實(shí)際運(yùn)行中獲得的數(shù)據(jù)作為文件的依據(jù)，以證明該工藝能達(dá)到預(yù)期要求。" </p> <p> <br /> </p> <p> <br /> 河北區(qū)計(jì)算機(jī)驗(yàn)證第三方檢測(cè)</p><p style="text-indent:25px">旦霆生物科技（上海）有限公司屬于醫(yī)藥、保養(yǎng)的高新企業(yè)，技術(shù)力量雄厚。公司是一家私營(yíng)有限責(zé)任公司企業(yè)，以誠(chéng)信務(wù)實(shí)的創(chuàng)業(yè)精神、質(zhì)量高效的管理團(tuán)隊(duì)、精悍的職工隊(duì)伍，努力為廣大用戶提供***的產(chǎn)品。公司業(yè)務(wù)涵蓋[ "GMP驗(yàn)證咨詢與服務(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)" ]，價(jià)格合理，品質(zhì)有保證，深受廣大客戶的歡迎。旦霆科技以創(chuàng)造***產(chǎn)品及服務(wù)的理念，打造高指標(biāo)的服務(wù)，引導(dǎo)行業(yè)的發(fā)展。</p></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/950968.html</p></div></div></div></div></div><div id="cgyvc3c" class="page-right twoColRt"><div id="pebnpbd" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="34urjby" 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="1ynzwiz" 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" 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