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id="en8isjq" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335296157607422/4527074.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="w228c2d" 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>安徽旦霆科技滅菌柜驗(yàn)證質(zhì)量保證,滅菌柜驗(yàn)證</p><p><span>***更新：</span>2021-01-13 01:07:09</p><p><span id="click" >瀏覽次數(shù)：4次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="3b4l733" 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="exzr6yv" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="rgyqiar" class="box"><p><p> 設(shè)備驗(yàn)證的內(nèi)容。設(shè)備驗(yàn)證一般包括四個(gè)階段，分別為預(yù)確認(rèn)、安裝確認(rèn)、運(yùn)行確認(rèn)和性能確認(rèn)。預(yù)確認(rèn)，即設(shè)計(jì)確認(rèn)，通常指對(duì)待訂購(gòu)設(shè)備技術(shù)指標(biāo)適用性的審查及對(duì)供應(yīng)廠商的選定；安裝確認(rèn)，主要指機(jī)器設(shè)備安裝后進(jìn)行的各種系統(tǒng)檢查及技術(shù)資料的文件化工作；運(yùn)行確認(rèn)，為證明設(shè)備達(dá)到設(shè)定要求進(jìn)行的運(yùn)行試驗(yàn)；性能確認(rèn)，指模擬試生產(chǎn)，證實(shí)設(shè)備的穩(wěn)定性。 </p> <p> 通過(guò)在技術(shù)層面上對(duì)設(shè)備驗(yàn)證和設(shè)備管理的各個(gè)階段的對(duì)比，我們可以發(fā)現(xiàn)，設(shè)備的預(yù)確認(rèn)，即為設(shè)備管理中的前期管理；設(shè)備的安裝確認(rèn)、運(yùn)行確認(rèn)和性能確認(rèn)為設(shè)備管理中的過(guò)渡階段，安徽旦霆科技滅菌柜驗(yàn)證質(zhì)量保證，安徽旦霆科技滅菌柜驗(yàn)證質(zhì)量保證，安徽旦霆科技滅菌柜驗(yàn)證質(zhì)量保證。我們?cè)谠O(shè)備管理方面已經(jīng)積累了較多的經(jīng)驗(yàn)，而在設(shè)備驗(yàn)證方面，經(jīng)驗(yàn)則較為缺乏。如此一來(lái)，我們就可以結(jié)合設(shè)備管理來(lái)規(guī)范設(shè)備驗(yàn)證的工作，同樣，在設(shè)備驗(yàn)證過(guò)程中產(chǎn)生的關(guān)于設(shè)備方面的要求，可以用來(lái)進(jìn)一步規(guī)范設(shè)備管理方面的工作。下面就針對(duì)設(shè)備驗(yàn)證的各個(gè)階段，結(jié)合設(shè)備管理來(lái)進(jìn)行論述。 </p> <p> <br /> 旦霆科技先進(jìn)的進(jìn)口儀器，嚴(yán)謹(jǐn)?shù)馁|(zhì)量管理體系，為制藥企業(yè)量身定制滅菌柜驗(yàn)證、生產(chǎn)設(shè)備驗(yàn)證解決方案。安徽旦霆科技滅菌柜驗(yàn)證質(zhì)量保證</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽旦霆科技滅菌柜驗(yàn)證質(zhì)量保證,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335296157607422/4527074.png"></div><p> 歐盟GMP（WHO附錄4） </p> <p> 設(shè)計(jì)確認(rèn)（DQ） </p> <p> 新設(shè)施、系統(tǒng)或設(shè)備驗(yàn)證的DIYI個(gè)步驟為設(shè)計(jì)確認(rèn)。 </p> <p> 應(yīng)論證設(shè)計(jì)符合GMP要求，并應(yīng)有相應(yīng)的記錄。 </p> <p> 安裝確認(rèn)（IQ） </p> <p> 新的設(shè)施或改建的設(shè)施、系統(tǒng)或設(shè)備需安裝確認(rèn)。 </p> <p> 安裝確認(rèn)應(yīng)包括但不限于以下方面： </p> <p> 根據(jù)ZUI新的工程圖紙和技術(shù)規(guī)格/標(biāo)準(zhǔn)說(shuō)明書(shū)，檢查設(shè)備、管道、共用設(shè)施和儀器安裝； </p> <p> 校驗(yàn)要求； </p> <p> 收集及整理（歸檔）由供應(yīng)商提供的操作指南、維護(hù)保養(yǎng)手冊(cè)； </p> <p> 材質(zhì)證明的確認(rèn)。 </p> <p> 運(yùn)行確認(rèn)（OQ） </p> <p> 安裝確認(rèn)之后，應(yīng)接著進(jìn)行運(yùn)行確認(rèn)。 </p> <p> 運(yùn)行確認(rèn)應(yīng)包括但不限于以下方面： </p> <p> 根據(jù)生產(chǎn)工藝、系統(tǒng)和設(shè)備的相關(guān)知識(shí)制定OQ方案并進(jìn)行測(cè)試； </p> <p> 測(cè)試應(yīng)在一種或一組運(yùn)行條件之下進(jìn)行，包括設(shè)備運(yùn)行的上下限，有時(shí)稱這種條件為“ZUI 差條件”。重慶庫(kù)存管理軟件滅菌柜驗(yàn)證第三方旦霆科技布局藥企行業(yè)，目前為20余家相關(guān)行業(yè)的公司提供儀器設(shè)備驗(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="安徽旦霆科技滅菌柜驗(yàn)證質(zhì)量保證,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295736738282/6333870.png"></div><p> 驗(yàn)證的對(duì)象：生產(chǎn)工藝、操作規(guī)程和檢驗(yàn)方法 </p> <p> 方法：回顧性驗(yàn)證和同步驗(yàn)證。 </p> <p> </p> <p> 確認(rèn)的對(duì)象:廠房、設(shè)施、設(shè)備和檢驗(yàn)儀器 </p> <p> 方法：前驗(yàn)證和再驗(yàn)證 </p> <p> <br /> </p> <p> 用戶需求標(biāo)準(zhǔn) </p> <p> URS (user requirement specification):是指使用方對(duì)廠房、設(shè)施、設(shè)備和檢驗(yàn)儀器等硬件設(shè)施系統(tǒng)等提出的自己的期望使用需求說(shuō)明，這個(gè)需求綜合自己的使用目的、用途、環(huán)境等提出自己具體的方案，設(shè)備供應(yīng)商依據(jù)客戶提供的URS方案進(jìn)行設(shè)備設(shè)計(jì)（或確認(rèn)自己已經(jīng)完成設(shè)計(jì)的設(shè)備能符合需方的要求），待客戶完成DQ（設(shè)計(jì)確認(rèn)）后，再進(jìn)行設(shè)備的制造。 </p><p> 計(jì)算機(jī)化系統(tǒng)驗(yàn)證方案（目錄） </p> <p> 驗(yàn)證目的 </p> <p> 驗(yàn)證范圍 </p> <p> 職責(zé)確認(rèn) </p> <p> 指導(dǎo)文件確認(rèn) </p> <p> 術(shù)語(yǔ)縮寫 </p> <p> 驗(yàn)證實(shí)施前提條件 </p> <p> 人員確認(rèn) </p> <p> 風(fēng)險(xiǎn)評(píng)估 </p> <p> 驗(yàn)證時(shí)間安排 </p> <p> 驗(yàn)證內(nèi)容 </p> <p> 偏差處理 </p> <p> 風(fēng)險(xiǎn)的接收與評(píng)審 </p> <p> 確認(rèn)計(jì)劃 </p> <p> 驗(yàn)證譜圖編制 </p> <p> 審核、結(jié)論 </p> <p> 驗(yàn)證目的 </p> <p> 某公司質(zhì)量檢驗(yàn)部現(xiàn)有一臺(tái)某型號(hào)的紫外分光光度計(jì)，與工作站軟件、計(jì)算機(jī)系統(tǒng)及打印機(jī)組成色譜儀計(jì)算機(jī)化系統(tǒng)。為保證這些系統(tǒng)符合GMP標(biāo)準(zhǔn)，滿足使用要求和分析測(cè)試需求，保證數(shù)據(jù)的安全，特制的本驗(yàn)證方案，以進(jìn)行計(jì)算機(jī)化系統(tǒng)驗(yàn)證。專注滅菌柜及培養(yǎng)基制備，專業(yè)，精細(xì)，數(shù)據(jù)可靠。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽旦霆科技滅菌柜驗(yàn)證質(zhì)量保證,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294414755860/4492022.png"></div><p> 歐盟GMP (WHO附錄4）附錄15：確認(rèn)和驗(yàn)證 </p> <p> 必須制定相關(guān)的驗(yàn)證方案，詳細(xì)說(shuō)明確認(rèn)和驗(yàn)證將如何進(jìn)行。方案應(yīng)當(dāng)經(jīng)過(guò)審核和批準(zhǔn)。驗(yàn)證方案應(yīng)詳細(xì)描述關(guān)鍵步驟和可接受標(biāo)準(zhǔn)。 </p> <p> 應(yīng)按照確認(rèn)和/或驗(yàn)證方案編寫驗(yàn)證報(bào)告，匯總獲得的數(shù)據(jù)和結(jié)果、對(duì)觀察到的偏差進(jìn)行評(píng)估、得出必要的結(jié)論，提出必要的糾偏措施。確認(rèn)/驗(yàn)證方案中的計(jì)劃的變更，應(yīng)有相應(yīng)記錄并有適當(dāng)?shù)慕忉尅?</p> <p> 確認(rèn)完成且結(jié)果令人滿意時(shí)，應(yīng)有書(shū)面批準(zhǔn)，同意進(jìn)入下一步的確認(rèn)和驗(yàn)證工作。 </p> <p> <br /> 旦霆科技團(tuán)隊(duì)成員掌握國(guó)內(nèi)為GMP、國(guó)標(biāo)、ISO等相關(guān)法規(guī)，可為相關(guān)企業(yè)開(kāi)展滅菌柜驗(yàn)證等服務(wù)。湖南QMS系統(tǒng)滅菌柜驗(yàn)證驗(yàn)證公司</p><p style="text-indent:25px">旦霆科技為制藥行業(yè)等企業(yè)提供驗(yàn)證測(cè)試服務(wù)。對(duì)耗材供應(yīng)商進(jìn)行年審、為項(xiàng)目進(jìn)行及服務(wù)客戶把好關(guān)！安徽旦霆科技滅菌柜驗(yàn)證質(zhì)量保證</p><p> PQ測(cè)試種類： </p> <p> 微生物測(cè)試 </p> <p> 化學(xué)測(cè)試 </p> <p> 顆粒度測(cè)試 </p> <p> 負(fù)載測(cè)試 </p> <p> 產(chǎn)品或placebo性能測(cè)試 </p> <p> 驗(yàn)證技術(shù)范圍： </p> <p> HVAC（關(guān)鍵區(qū)域） </p> <p> Cleanroom潔凈室驗(yàn)證 </p> <p> Utilities關(guān)鍵的公用工程系統(tǒng)驗(yàn)證 </p> <p> （PFW,WFI,N2,壓縮空氣和潔凈蒸汽系統(tǒng)） </p> <p> Process Equipment 工藝設(shè)備驗(yàn)證 </p> <p> Process/Sterilisation Process工藝/消毒工藝驗(yàn)證 </p> <p> Laboratory Equipment 實(shí)驗(yàn)室設(shè)備驗(yàn)證 </p> <p> Analytical Methods 分析方法的驗(yàn)證 </p> <p> Cleaning 清潔驗(yàn)證 </p> <p> Computerised Systems 計(jì)算機(jī)系統(tǒng)驗(yàn)證 </p> <p> 關(guān)鍵系統(tǒng)的驗(yàn)證 </p> <p> 系統(tǒng)要求驗(yàn)證 </p> <p> 直接和藥品接觸的系統(tǒng) </p> <p> 接觸原材料的系統(tǒng)，其ZUI終成為成品或直接和藥品接觸的系統(tǒng) </p> <p> 測(cè)量，監(jiān)控或記錄關(guān)鍵參數(shù)的系統(tǒng) </p> <p> 用于傳達(dá)或維護(hù)關(guān)鍵參數(shù)的系統(tǒng) 安徽旦霆科技滅菌柜驗(yàn)證質(zhì)量保證</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(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/2818555.html</p></div></div></div></div></div><div id="i74a9zl" class="page-right 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