江西3Q認(rèn)證公司有哪些誠信服務(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="二氧化碳培養(yǎng)箱3Q認(rèn)證內(nèi)容包括：IQ內(nèi)容:技術(shù)類文件確認(rèn),設(shè)備儀表校準(zhǔn)確認(rèn),安裝位置和安裝環(huán)境確認(rèn),部件安裝確認(rèn),公用系統(tǒng)連接確認(rèn)和標(biāo)識確認(rèn)OQ內(nèi)容：預(yù)確認(rèn)(確認(rèn)安裝確認(rèn)是否完成,安裝確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉，設(shè)備操作SOP是否已審批完成"><meta name="keywords" content="江西3Q認(rèn)證公司有哪些,3Q認(rèn)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" href="/static/new_net_01/css/404.css"> <meta 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href="http://www.cdcfah.com/cp/">產(chǎn)品供應(yīng)</a>?<a href="http://www.cdcfah.com/cp/second-_swfw/">商務(wù)服務(wù)</a>?<a href="http://www.cdcfah.com/cp/third-swfw_jiancefuwu/">檢測服務(wù)</a>?江西3Q認(rèn)證公司有哪些誠信服務(wù) 旦霆生物科技供應(yīng)</p><div id="qx7dn92" class="leftbox clearfix"><h1>江西3Q認(rèn)證公司有哪些誠信服務(wù) 旦霆生物科技供應(yīng)</h1><div id="7k9su0m" class="proBig"><div id="8y4spzq" class="bigimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309141064453/8232012.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="872oaug" class="smallimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309141064453/8232012.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="rlvmodk" 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>江西3Q認(rèn)證公司有哪些,3Q認(rèn)證</p><p><span>***更新：</span>2021-01-24 08:05:10</p><p><span id="click" >瀏覽次數(shù)：5次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="dsumtxe" 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="wbyv7mj" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="mryfhy3" class="box"><p><p> 二氧化碳培養(yǎng)箱3Q認(rèn)證內(nèi)容包括： </p> <p> IQ內(nèi)容: 技術(shù)類文件確認(rèn), 設(shè)備儀表校準(zhǔn)確認(rèn), 安裝位置和安裝環(huán)境確認(rèn), 部件安裝確認(rèn), 公用系統(tǒng)連接確認(rèn)和標(biāo)識確認(rèn) </p> <p> OQ內(nèi)容：預(yù)確認(rèn)(確認(rèn)安裝確認(rèn)是否完成,安裝確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉，設(shè)備操作SOP是否已審批完成)，開啟/關(guān)閉確認(rèn)，報警功能確認(rèn)，數(shù)據(jù)記錄功能確認(rèn)，參數(shù)校準(zhǔn)功能確認(rèn)，空載溫度分布確認(rèn)，空載CO2濃度確認(rèn)，斷電挑戰(zhàn)試驗 </p> <p> PQ內(nèi)容：預(yù)確認(rèn)(確認(rèn)運(yùn)行確認(rèn)是否完成，安裝運(yùn)行確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉)，滿載溫度分布確認(rèn)，江西3Q認(rèn)證公司有哪些，滿載CO2濃度確認(rèn)，江西3Q認(rèn)證公司有哪些，開門挑戰(zhàn)試驗旦霆科技服務(wù)面向全國、3Q認(rèn)證及其他項目均安排項目經(jīng)理，對項目質(zhì)量，江西3Q認(rèn)證公司有哪些、質(zhì)量、進(jìn)度及時監(jiān)督。保證項目質(zhì)量！江西3Q認(rèn)證公司有哪些</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江西3Q認(rèn)證公司有哪些,3Q認(rèn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309141064453/8232012.jpg"></div><p> 回顧性驗證怎么做？ </p> <p> <p> 3Q認(rèn)證中，回顧驗證必須具備以下條件方可應(yīng)用： </p> <p> 1.至少有6批符合要求的數(shù)據(jù)，有20批以上的數(shù)據(jù)更好。 </p> <p> 2.檢驗方法已經(jīng)過驗證，檢驗的結(jié)果可以用數(shù)值表示，可以進(jìn)行統(tǒng)計分析。 </p> <p> 3.批記錄符合制藥GMP要求，記錄中有明確的工藝條件，且有關(guān)于偏差的分析說明。 </p> <p> 4.有關(guān)的工藝變量是標(biāo)準(zhǔn)化的，并一直處于控制狀態(tài)，如原料標(biāo)準(zhǔn)、潔凈區(qū)的級別、分析方法、微生物控制等。 </p> <p> 5.這種方式通常用于非無菌產(chǎn)品的工藝驗證，以積累的生產(chǎn)、檢驗和其他有關(guān)歷史資料為依據(jù)，回顧、分析工藝控制的全過程，證實其控制條件的有效件。 </p> 江西3Q認(rèn)證公司有哪些旦霆科技保證測試驗證數(shù)據(jù)真實、測試人員專業(yè)、性價比高。為客戶提供3Q認(rèn)證服務(wù)及技術(shù)咨詢！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江西3Q認(rèn)證公司有哪些,3Q認(rèn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309137441406/177428.jpg"></div><p> 離心機(jī)、3Q認(rèn)證內(nèi)容包括： </p> <p> PQ內(nèi)容：1.根據(jù)甲方SOP運(yùn)行3次 </p> <p> OQ內(nèi)容：1.預(yù)確認(rèn)(確認(rèn)安裝確認(rèn)是否完成,安裝確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉，2.設(shè)備操作SOP是否已審批完成)，3.啟動/關(guān)閉確認(rèn)，4.按鍵功能確認(rèn)，5.參數(shù)設(shè)置功能確認(rèn)，6.轉(zhuǎn)速確認(rèn)，7.計時器比對確認(rèn)，8.溫度控制功能確認(rèn)，9.升/降速時間確認(rèn)，10.噪聲確認(rèn)，11.報警/安全功能確認(rèn) </p> <p> IQ內(nèi)容: 1.技術(shù)類文件確認(rèn), 2.設(shè)備儀表校準(zhǔn)確認(rèn), 3.安裝位置和安裝環(huán)境確認(rèn), 4.部件安裝確認(rèn), 5.公用系統(tǒng)連接確認(rèn)和標(biāo)識確認(rèn) </p> <p> <br /> </p> <p> <br /> </p><p> 生物反應(yīng)器3Q認(rèn)證包括： </p> <p> PQ：性能確認(rèn) 是對設(shè) 備總體的檢驗，是對照用戶需求說明中對性能描述進(jìn) 行的 *** 確認(rèn) ，在 P Q 執(zhí)行時，需要使用一定的模擬物料，需要考慮設(shè) 備比較大 </p> <p> <p> OQ內(nèi)容：設(shè) 備正常啟動、運(yùn) 行、關(guān) 閉和重啟， </p> <p> 溫度、pH 、DO2、溶二氧化碳 DC O2 等控制功能和控制曲線，同時考察各控制器如電動或氣動閥門的動作，進(jìn) 料和出料的功能，稱重系統(tǒng) 或液位控制，攪拌槳控制和轉(zhuǎn) 速的調(diào) 節(jié)，控制系統(tǒng) 功能的確認(rèn) ，包括登陸、權(quán) 限、報警、記錄、報表等功能的確認(rèn)，C I P 和 s i p 功能的確認(rèn)，安全防護(hù) 功能的確認(rèn)等： </p> <p> IQ內(nèi)容: 技術(shù)類文件確認(rèn), 設(shè)備儀表校準(zhǔn)確認(rèn), 安裝位置和安裝環(huán)境確認(rèn), 圖紙確認(rèn)（管道連接，包括管件的安裝順序和方向）部件安裝確認(rèn)（包括罐的尺寸、安裝方式、水平，與產(chǎn) 品直接接觸的部件的材質(zhì)，各種控制、監(jiān) 視用的傳感器的品牌、型號、材質(zhì) 和安裝位置）, 公用系統(tǒng)連接確認(rèn)，控制軟件的名稱、版木號和標(biāo)識確認(rèn)，IO測試（數(shù) 字量/模擬量輸入和輸出的檢査，可引用SAT中IO測試結(jié)果） </p> 旦霆科技針對于中大型驗證及測試項目均配備項目經(jīng)理，在為提供3Q認(rèn)證服務(wù)時及時匯報進(jìn)、嚴(yán)格控制質(zhì)量！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江西3Q認(rèn)證公司有哪些,3Q認(rèn)證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309147939453/5125649.jpg"></div><p> 倉庫Q認(rèn)證內(nèi)容包括： </p> <p> PQ內(nèi)容：1.預(yù)確認(rèn)(確認(rèn)運(yùn)行確認(rèn)是否完成，2.安裝運(yùn)行確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉)，3. 滿載溫濕度分布確認(rèn)，4.開門挑戰(zhàn)試驗，5.斷電挑戰(zhàn)試驗 </p> <p> <p> OQ內(nèi)容：1.預(yù)確認(rèn)(確認(rèn)安裝確認(rèn)是否完成,安裝確認(rèn)中出現(xiàn)的偏差是否已關(guān)閉，2.設(shè)備操作SOP是否已審批完成)，3.空調(diào)系統(tǒng)開啟/關(guān)閉確認(rèn)，4.空載溫濕度分布確認(rèn) <span style="font-size:12px;"></span> </p> </p> <p> IQ內(nèi)容: 1.文件確認(rèn)（圖紙確認(rèn)，技術(shù)文件確認(rèn)）,2.儀器/儀表校準(zhǔn)確認(rèn)，3.部件安裝確認(rèn)，4.公用系統(tǒng)連接確認(rèn)和標(biāo)識確認(rèn) </p> <p> <br /> 旦霆科技不但擁有龐大的驗證及檢測團(tuán)隊，同時配備幾百套驗證及檢測儀器，專業(yè)開展3Q認(rèn)證服務(wù)！江西3Q認(rèn)證公司有哪些</p><p style="text-indent:25px">旦霆科技團(tuán)隊成員精通、掌握國內(nèi)為GMP、國標(biāo)、ISO、ISPE等相關(guān)法規(guī)，可為相關(guān)企業(yè)開展3Q認(rèn)證等服務(wù)。江西3Q認(rèn)證公司有哪些</p><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認(rèn)證；1.系統(tǒng)是否包含CAs/CDEs或執(zhí)行滿足包括CPPs在內(nèi)的一個或多個流程需求(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?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)是否會影響**終產(chǎn)品質(zhì)量或?qū)颊邩?gòu)成風(fēng)險?4.系統(tǒng)是否用于清潔、消毒或滅菌，系統(tǒng)故障是否會導(dǎo)致無法充分清潔、消毒或滅菌，從而給患者帶來風(fēng)險?5.系統(tǒng)建立一個適當(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，其功能會導(dǎo)致患者健康的風(fēng)險?6.系統(tǒng)是否使用、生產(chǎn)、處理或存儲用于接受或拒絕產(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)險或產(chǎn)品質(zhì)量下降? 江西3Q認(rèn)證公司有哪些</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> 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