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id="h72m1cn" 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>安徽生產(chǎn)控制系統(tǒng)滅菌柜驗(yàn)證怎么做,滅菌柜驗(yàn)證</p><p><span>***更新：</span>2021-01-15 02:04:15</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="soilzaf" 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="c7vkqb0" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="rcudvky" class="box"><p><p> “驗(yàn)證”與“儀器驗(yàn)證” </p> <p> <br /> </p> <p> 要弄清楚儀器驗(yàn)證，首先要清楚兩個(gè)概念，何為驗(yàn)證（Verification），何為儀器驗(yàn)證（Verification of Instruments），根據(jù)ISO/IEC 17025的定義，驗(yàn)證是指通過提供客觀證據(jù)，安徽生產(chǎn)控制系統(tǒng)滅菌柜驗(yàn)證怎么做，證明給定項(xiàng)目滿足規(guī)定要求。由此延伸到儀器驗(yàn)證則為對(duì)儀器進(jìn)行核查，通過保留驗(yàn)證過程中產(chǎn)生的資料，證明某個(gè)儀器能滿足用戶的使用需求。 </p> <p> <br /> </p> <p> CNAS-GL040:2019中將儀器驗(yàn)證的定義作了擴(kuò)充，幾乎將儀器的整個(gè)生命周期納入到了儀器驗(yàn)證的活動(dòng)中來，儀器驗(yàn)證的定義有了更豐富的內(nèi)涵———對(duì)儀器在采購(gòu)、安裝、驗(yàn)收和運(yùn)行階段實(shí)施核查，證明儀器能夠達(dá)到預(yù)期結(jié)果的一系列活動(dòng)。 </p> <p> <br /> 旦霆科技團(tuán)隊(duì)成員掌握國(guó)內(nèi)為GMP，安徽生產(chǎn)控制系統(tǒng)滅菌柜驗(yàn)證怎么做，安徽生產(chǎn)控制系統(tǒng)滅菌柜驗(yàn)證怎么做、國(guó)標(biāo)、ISO等相關(guān)法規(guī)，可為相關(guān)企業(yè)開展滅菌柜驗(yàn)證等服務(wù)。安徽生產(chǎn)控制系統(tǒng)滅菌柜驗(yàn)證怎么做</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽生產(chǎn)控制系統(tǒng)滅菌柜驗(yàn)證怎么做,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295736738282/6333870.png"></div><p> 設(shè)計(jì)確認(rèn)（DQ） </p> <p> 設(shè)計(jì)確認(rèn)是書面確認(rèn)該設(shè)備的設(shè)計(jì)能夠滿足用戶需求。質(zhì)量管理人員需要批準(zhǔn)設(shè)計(jì)確認(rèn)報(bào)告，報(bào)告批準(zhǔn)后，對(duì)設(shè)計(jì)的任何變化需要提出正式的變更申請(qǐng)。 </p> <p> 安裝確認(rèn)（IQ） </p> <p> 安裝確認(rèn)是確認(rèn)所有可能影響產(chǎn)品質(zhì)量的設(shè)施、設(shè)備的各個(gè)方面都要符合要求（例如結(jié)構(gòu)、材料）并且正確安裝。安裝確認(rèn)方案應(yīng)確認(rèn)設(shè)計(jì)與實(shí)際安裝相一致，安裝確認(rèn)方案必須在進(jìn)行安裝確認(rèn)前批準(zhǔn)，并且經(jīng)過培訓(xùn)的人員才可以執(zhí)行。 </p> <p> 運(yùn)行確認(rèn)（OQ） </p> <p> 運(yùn)行確認(rèn)是確認(rèn)設(shè)備所有可能影響產(chǎn)品質(zhì)量的各個(gè)方面都在預(yù)期的范圍之內(nèi)運(yùn)行。 </p> <p> 所有質(zhì)量關(guān)鍵部件必須根據(jù)預(yù)先審批的測(cè)試方案進(jìn)行測(cè)試，測(cè)試的方法和范圍將根據(jù)設(shè)備的類型和復(fù)雜程度，以及設(shè)備的關(guān)鍵程度而定。 </p> <p> 性能確認(rèn)/工藝驗(yàn)證（PQ/PV） </p> <p> 就生產(chǎn)設(shè)備而言，性能確認(rèn)系指通過設(shè)備整體運(yùn)行的方法，考察工藝設(shè)備運(yùn)行的可靠性、主要運(yùn)行參數(shù)的穩(wěn)定性和運(yùn)行結(jié)果重現(xiàn)性的一系列活動(dòng)。故其實(shí)際意義即指模擬生產(chǎn)或工藝驗(yàn)證，通常模擬生產(chǎn)或工藝驗(yàn)證至少應(yīng)重復(fù)三次。對(duì)于比較簡(jiǎn)單、運(yùn)行較為穩(wěn)定、人員已有一定同類設(shè)備實(shí)際運(yùn)行經(jīng)驗(yàn)或基于風(fēng)險(xiǎn)評(píng)估風(fēng)險(xiǎn) 安徽生產(chǎn)控制系統(tǒng)滅菌柜驗(yàn)證怎么做旦霆科技專業(yè)提供計(jì)算機(jī)化系統(tǒng)驗(yàn)證、空調(diào)系統(tǒng)及潔凈室驗(yàn)證、生產(chǎn)設(shè)備驗(yàn)證、滅菌柜驗(yàn)證等驗(yàn)證咨詢與服務(wù)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽生產(chǎn)控制系統(tǒng)滅菌柜驗(yàn)證怎么做,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335293616376954/1769054.png"></div><p> 本文件主要依據(jù)ISO/IEC 17025標(biāo)準(zhǔn)和USP1058《分析儀器驗(yàn)證指導(dǎo)原則》編制，同時(shí)參考了我國(guó)的《藥品生產(chǎn)質(zhì)量管理規(guī)范 (2010 年修訂 )》等有關(guān)文件，可為實(shí)驗(yàn)室規(guī)范儀器設(shè)備管理提供指導(dǎo)。本文件滿足 ISO/IEC 17025 標(biāo)準(zhǔn)對(duì)儀器設(shè)備的要求，是針對(duì)儀器設(shè)備的更***、具體管理指導(dǎo)性文件。 </p> <p> 本文件對(duì)儀器驗(yàn)證各階段具體實(shí)施提供了指南，注重儀器對(duì)預(yù)期用途的適用性，可用于常規(guī)檢測(cè)實(shí)驗(yàn)室對(duì)各類儀器的管理。為給實(shí)驗(yàn)室施證提供具體指導(dǎo)，本文件以目前檢測(cè)實(shí)驗(yàn)室中使用較為***的液相色譜儀例，提供了實(shí)施儀器驗(yàn)證的具體范例。 </p><p> 設(shè)計(jì)確認(rèn) </p> <p> <br /> </p> <p> 在CNAS-GL040:2019的儀器驗(yàn)證中，將滿足用戶需求作為**重要的指標(biāo)，因此在儀器購(gòu)買前，用戶就必須編制儀器采購(gòu)技術(shù)文件（軟件和硬件），提出所需采購(gòu)儀器設(shè)備的使用條件和技術(shù)參數(shù)及性能要求，同時(shí)還要對(duì)供應(yīng)商進(jìn)行評(píng)價(jià)，這與“4Q驗(yàn)證”中的設(shè)計(jì)確認(rèn)相類似，設(shè)計(jì)確認(rèn)就是客戶確認(rèn)儀器能否滿足自己需求的過程。 </p> <p> <br /> </p> <p> 但在實(shí)驗(yàn)室實(shí)際的設(shè)計(jì)確認(rèn)過程中，實(shí)驗(yàn)室往往對(duì)自己的需求并不了解，或沒有明確的技術(shù)指標(biāo)，導(dǎo)致實(shí)際的設(shè)計(jì)確認(rèn)過程均以儀器供應(yīng)商提供的技術(shù)參數(shù)作為設(shè)計(jì)確認(rèn)的依據(jù)，設(shè)計(jì)確認(rèn)及用戶需求說明變得可有可無了。實(shí)際上實(shí)驗(yàn)室的儀器技術(shù)文件不**是確認(rèn)儀器參數(shù)能否滿足自身需求的文件，同時(shí)也是儀器整個(gè)生命周期中進(jìn)行驗(yàn)證的重要依據(jù)。 </p> <p> <br /> 旦霆科技保證測(cè)試驗(yàn)證數(shù)據(jù)真實(shí)、測(cè)試人員專業(yè)、性價(jià)比高。為客戶提供滅菌柜驗(yàn)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="安徽生產(chǎn)控制系統(tǒng)滅菌柜驗(yàn)證怎么做,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335293110195313/2026151.png"></div><p> URS容易出現(xiàn)的問題： </p> <p> 使用單位不能提供詳細(xì)具體的URS為設(shè)計(jì)單位作為設(shè)計(jì)依據(jù)； </p> <p> 不能提出劑型、品種、工藝、產(chǎn)品的質(zhì)量標(biāo)準(zhǔn)或相應(yīng)的操作程序； </p> <p> 對(duì)產(chǎn)量、班次、物流控制方面不了解、不專業(yè)和不擅長(zhǎng)； </p> <p> 不能按自身的生產(chǎn)工藝需要向制藥裝備廠商提出具體的GMP要求； </p> <p> 不能把GMP的對(duì)應(yīng)要求做細(xì)化理解，關(guān)鍵節(jié)點(diǎn)把握不準(zhǔn)確。如潔凈度控制、壓差梯度、氣鎖裝置等； </p> <p> 一份編寫良好的URS用戶需求規(guī)范，不*考慮工藝要求，而且考慮與GMP的符合性以及驗(yàn)證要求。壓縮空氣檢測(cè)機(jī)構(gòu)，壓縮空氣微生物檢測(cè)，提供CMA/CNAS資質(zhì)檢測(cè)，出具CMA資質(zhì)認(rèn)證及報(bào)告。安徽生產(chǎn)控制系統(tǒng)滅菌柜驗(yàn)證怎么做</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)！安徽生產(chǎn)控制系統(tǒng)滅菌柜驗(yàn)證怎么做</p><p> 設(shè)備的驗(yàn)證可以說是每個(gè)行業(yè)在投入到批量生產(chǎn)前都必須要做的，后期也要根據(jù)產(chǎn)品設(shè)備的反饋情況來進(jìn)行設(shè)備的抽查檢測(cè)，不斷的完善設(shè)備的性能提高用戶的滿意度，那么具體如何操作***給大家介紹一下。 </p> <p> 檢測(cè)試用預(yù)確認(rèn)、安裝確認(rèn)、運(yùn)行確認(rèn)、性能確認(rèn)組成，所以再驗(yàn)證的范圍很廣 </p> <p> 設(shè)備可以的運(yùn)作通常需要硬件和軟件的配合，硬件按照軟件設(shè)定的程序來運(yùn)行，硬件問題是會(huì)通過外觀、聲響等表現(xiàn)出來，容易被人察覺的。這個(gè)時(shí)候檢查人員需要在設(shè)備的組裝、運(yùn)行、性能等方面來進(jìn)行觀察。 </p> <p> 任何的設(shè)備在使用的過程中或多或少都會(huì)消耗和破損，所以這個(gè)設(shè)備的檢查需要根據(jù)使用頻率和強(qiáng)度來指定維護(hù)的期限，確保不會(huì)出現(xiàn)事故，盡可能的避免不必要的損失。安徽生產(chǎn)控制系統(tǒng)滅菌柜驗(yàn)證怎么做</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(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>文章來源地址: http://www.cdcfah.com/cp/2849109.html</p></div></div></div></div></div><div id="yxl7m4h" class="page-right twoColRt"><div id="d1h7ijz" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="hbtq32d" 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="i5xhdmb" 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(chéng)推薦寧波助學(xué)商務(wù)信息咨詢供應(yīng)" 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