重慶微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司創(chuàng)新服務(wù) 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="生物學(xué)測定方法驗(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）測定。生物活性測定包括以下方法：1.動(dòng)"><meta name="keywords" content="重慶微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司,驗(yàn)證咨詢公司"><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 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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>重慶微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司,驗(yàn)證咨詢公司</p><p><span>***更新：</span>2021-01-28 08:04:16</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="kxuwjgs" 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="hqxzw3k" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="yw3mtyp" class="box"><p><p> 生物學(xué)測定方法驗(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）測定。生物活性測定包括以下方法：1.動(dòng)物試驗(yàn)方法，2.在細(xì)胞水平上測定產(chǎn)品的生化和生理效應(yīng)的細(xì)胞培養(yǎng)檢測方法；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)等方法測定生物活性的生化檢測方法。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，對于非標(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，重慶微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司、原液或制劑中有效成分的含量測定及生物活性測定。旦霆科技專業(yè)提供CSV證，服務(wù)面向全國，重慶微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司，至今為各大制藥企業(yè)，重慶微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司、外企、上市公司提供質(zhì)量服務(wù)。重慶微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="重慶微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431524511718/1685851.jpg"></div><p> <br /> </p> <p> 風(fēng)險(xiǎn)評估是一種用于評估并描述系統(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 </p> <p> mode effects analysis, FMEA)或其他風(fēng)險(xiǎn)評估工具來找出可能失效的影響。風(fēng)險(xiǎn)評估結(jié)果以表格形式提供，每一行分別對應(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)具有對應(yīng)編號。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，并分析其失效的可能性，危害嚴(yán)重性以及失效的可檢測性，將失效模式分為高中低三級，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，對關(guān)鍵功能模塊進(jìn)行定期維護(hù)，定期再驗(yàn)證等）。GMP驗(yàn)證咨詢服務(wù)過程中風(fēng)險(xiǎn)評估是為了簡化驗(yàn)證和減少不必要的確認(rèn)活動(dòng)，應(yīng)通過風(fēng)險(xiǎn)評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。重慶微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司旦霆科技年度營業(yè)額以50%的速度高速增長，逐漸成為為數(shù)不多的中大型CSV驗(yàn)證測試服務(wù)的綜合性公司。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="重慶微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431532265625/5596974.png"></div><p> 什么是4Q? </p> <p> 關(guān)于儀器驗(yàn)證，比如說，一套完整的儀器設(shè)備驗(yàn)證方案，將包括4個(gè)部分，即4Q，分別為： </p> <p> DQ，設(shè)計(jì)確認(rèn)：確認(rèn)設(shè)備的設(shè)計(jì)符合用戶需求規(guī)范及相關(guān)法規(guī)。 </p> <p> IQ，安裝確認(rèn)：確認(rèn)儀器文件、部件及安裝過程。 </p> <p> OQ，運(yùn)行確認(rèn)：確認(rèn)儀器在空轉(zhuǎn)狀態(tài)下，在操作的極限范圍內(nèi)能正常的運(yùn)轉(zhuǎn)。 </p> <p> PQ，性能確認(rèn)：確認(rèn)儀器載樣運(yùn)行下是否符合標(biāo)準(zhǔn)規(guī)定。 </p> <p> <p> 什么是3Q? </p> <p> 由于實(shí)驗(yàn)室所用儀器均有儀器廠家研發(fā)設(shè)計(jì)而成，因此DQ(設(shè)計(jì)確認(rèn))在儀器驗(yàn)證中可以不做，所以本文提到的3Q，是指以上IQ(安裝確認(rèn))、OQ(運(yùn)行確認(rèn))、PQ(性能確認(rèn))。 </p> <p> 也就是說實(shí)驗(yàn)室儀器驗(yàn)證是從IQ(安裝確認(rèn))做起，再做OQ(運(yùn)行確認(rèn))、PQ(性能確認(rèn))，就完成了一套儀器驗(yàn)證的整套資料。 </p> </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，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)過程中對于不能滿足的用戶需求應(yīng)進(jìn)行記錄，并通過評估以及與供應(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。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 /> 旦霆科技作為國內(nèi)為數(shù)不多的中大規(guī)模驗(yàn)證公司，專業(yè)提供CSV驗(yàn)證服務(wù)，擁有幾十人的驗(yàn)證團(tuán)隊(duì)，值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="重慶微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431524472656/9507670.png"></div><p> 什么是系統(tǒng)分類（SC），怎么做？ </p> <p> ISPE基準(zhǔn)指南卷5《調(diào)試與確認(rèn)》(2019）中列出以下8個(gè)問題將系統(tǒng)分為直接影響系統(tǒng)和間接影響系統(tǒng)，如其中一個(gè)問題回答為”是”，則改系統(tǒng)應(yīng)判定為直接影響系統(tǒng)，我司可提供{3Q驗(yàn)證}/{3Q認(rèn)證}/{GMP咨詢}/{GMP驗(yàn)證咨詢服務(wù)}；：1.系統(tǒng)是否包含CAs/CDEs或執(zhí)行滿足包括CPPs在內(nèi)的一個(gè)或多個(gè)流程需求(CQAs)的功能?2.系統(tǒng)是否與產(chǎn)品或生產(chǎn)流程有直接接觸，并且這種接觸有可能影響**終產(chǎn)品質(zhì)量或?qū)颊邩?gòu)成風(fēng)險(xiǎn)?3.該系統(tǒng)是否提供輔料或生產(chǎn)成分或溶劑(如WFI)，以及該物質(zhì)的質(zhì)量(以其質(zhì)量標(biāo)準(zhǔn)而論)是否會(huì)影響**終產(chǎn)品質(zhì)量或?qū)颊邩?gòu)成風(fēng)險(xiǎn)?4.系統(tǒng)是否用于清潔、消毒或滅菌，系統(tǒng)故障是否會(huì)導(dǎo)致無法充分清潔、消毒或滅菌，從而給患者帶來風(fēng)險(xiǎn)?5.系統(tǒng)建立一個(gè)適當(dāng)?shù)沫h(huán)境(如氮?dú)獗Ｗo(hù)，密閉流程，暴露灌裝區(qū)區(qū)空氣質(zhì)量，維持產(chǎn)品溫濕度等等產(chǎn)品關(guān)鍵工藝參數(shù))，這前列程失效情況下，其功能會(huì)導(dǎo)致患者健康的風(fēng)險(xiǎn)?6.系統(tǒng)是否使用、生產(chǎn)、處理或存儲(chǔ)用于接受或拒絕產(chǎn)品、CPPS 或電子記錄的數(shù)據(jù)，以符合 21CFR第11部和歐盟 GMP 第 4 卷第 11部[21]或本地同等標(biāo)準(zhǔn)?7.該系統(tǒng)是否提供容器封口或產(chǎn)品保護(hù)，如果封口或產(chǎn)品保護(hù)失敗，將對患者構(gòu)成風(fēng)險(xiǎn)或產(chǎn)品質(zhì)量下降? </p> <p> <br /> 旦霆科技配備幾百套驗(yàn)證及檢測儀器，專業(yè)的驗(yàn)證及檢測服務(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。重慶微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司</p><p style="text-indent:25px">旦霆科技配備專業(yè)的質(zhì)量部，進(jìn)行驗(yàn)證審核、報(bào)告審核等質(zhì)量監(jiān)管，專業(yè)提供CSV驗(yàn)證及咨詢服務(wù)，值得信賴！重慶微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司</p><p> 同步驗(yàn)證怎么做? </p> <p> GMP驗(yàn)證咨詢服務(wù)中，同步驗(yàn)證是在工藝常規(guī)運(yùn)行的同時(shí)進(jìn)行的驗(yàn)證，即從工藝實(shí)際運(yùn)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(xiàng)工藝達(dá)到預(yù)計(jì)要求的活動(dòng)。以水系統(tǒng)驗(yàn)證為例，人們很難制造一個(gè)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(yùn)行參數(shù)的調(diào)控范圍，這種條件下，同步驗(yàn)證成了合理的選擇。這種情況下，工藝驗(yàn)證的實(shí)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(yàn)證過程中，可以同時(shí)獲得兩方面的結(jié)果：一是合格的產(chǎn)品，二是驗(yàn)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(yàn)證與生產(chǎn)同時(shí)進(jìn)行，因此該驗(yàn)證方式可能帶來產(chǎn)品質(zhì)量方面的風(fēng)險(xiǎn)，因此，企業(yè)應(yīng)根據(jù)自己的實(shí)際情況作出適當(dāng)?shù)倪x擇，且在制定驗(yàn)證方案并實(shí)施驗(yàn)證時(shí)，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(jì)驗(yàn)證結(jié)果對保證質(zhì)量可靠性的風(fēng)險(xiǎn)程度。重慶微生物實(shí)驗(yàn)室驗(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(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/3046780.html</p></div></div></div></div></div><div id="tju2uhe" class="page-right twoColRt"><div id="wv9jqmj" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="eoizgne" 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="mbvnu8w" 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(gè)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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