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旦霆生物科技供應(yīng)</p><div id="jipm8i2" class="leftbox clearfix"><h1>湖北GMP認(rèn)證滅菌柜驗(yàn)證第三方創(chuàng)新服務(wù) 旦霆生物科技供應(yīng)</h1><div id="yr7wd8d" class="proBig"><div id="xmjbkby" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295785400391/920118.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="bkh3p7h" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295785400391/920118.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="jtpmdpg" 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>湖北GMP認(rèn)證滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證</p><p><span>***更新：</span>2021-01-27 02:03:55</p><p><span id="click" >瀏覽次數(shù)：3次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="8gcjar7" 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="uiu8zy2" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="zmtawif" class="box"><p><p> ***百三十九條企業(yè)的廠房、設(shè)施、設(shè)備和檢驗(yàn)儀器應(yīng)經(jīng)過(guò)確認(rèn)，應(yīng)采用經(jīng)過(guò)驗(yàn)證的生產(chǎn)工藝、操作規(guī)程和檢驗(yàn)方法進(jìn)行生產(chǎn)、操作和檢驗(yàn)，并保持持續(xù)的驗(yàn)證狀態(tài)。 </p> <p> ***百四十條應(yīng)建立確認(rèn)和驗(yàn)證的文件和記錄，并能以文件和記錄證明達(dá)到以下預(yù)定的目標(biāo)： </p> <p> （一）設(shè)計(jì)確認(rèn)（DQ）應(yīng)證明廠房，湖北GMP認(rèn)證滅菌柜驗(yàn)證第三方、設(shè)施、設(shè)備的設(shè)計(jì)符合預(yù)定用途和本規(guī)范要求； </p> <p> （二）安裝確認(rèn)（IQ）應(yīng)證明廠房、設(shè)施和設(shè)備的建造和安裝符合設(shè)計(jì)標(biāo)準(zhǔn)； </p> <p> （三）運(yùn)行確認(rèn)（OQ）應(yīng)證明廠房、設(shè)施和設(shè)備的運(yùn)行符合設(shè)計(jì)標(biāo)準(zhǔn)； </p> <p> （四）性能確認(rèn)（PQ）應(yīng)證明廠房、設(shè)施，湖北GMP認(rèn)證滅菌柜驗(yàn)證第三方、設(shè)備在正常操作方法和工藝條件下能持續(xù)符合標(biāo)準(zhǔn)。 </p> <p> （五）工藝驗(yàn)證（PV）應(yīng)證明一個(gè)生產(chǎn)工藝按規(guī)定的工藝參數(shù)能持續(xù)生產(chǎn)出符合預(yù)定的用途和注冊(cè)要求的產(chǎn)品。 </p> <p> <br /> </p> <p> <br /> 旦霆科技作為專業(yè)的設(shè)備驗(yàn)證及第三方檢測(cè)供應(yīng)商，湖北GMP認(rèn)證滅菌柜驗(yàn)證第三方，取得良好的客戶口碑，我們繼續(xù)保持高水準(zhǔn)服務(wù)全國(guó)。湖北GMP認(rèn)證滅菌柜驗(yàn)證第三方</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北GMP認(rèn)證滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295785400391/920118.png"></div><p> 設(shè)備驗(yàn)證合格后，**終確認(rèn)的內(nèi)容有：設(shè)備編號(hào)、操作規(guī)程、維護(hù)規(guī)程、點(diǎn)檢卡、潤(rùn)滑卡、檢修計(jì)劃、備品配件臺(tái)賬、模具臺(tái)賬等。日常使用的包括設(shè)備運(yùn)行（使用）記錄、模具領(lǐng)用記錄、維護(hù)檢修記錄、潤(rùn)滑記錄、儀器儀表記錄等。并將相關(guān)記錄整理歸檔：調(diào)研報(bào)告、合同、開(kāi)箱驗(yàn)收記錄、裝箱單、安裝驗(yàn)收記錄以及驗(yàn)證報(bào)告。驗(yàn)證確認(rèn)的各種內(nèi)容，在設(shè)備管理中應(yīng)有相應(yīng)的規(guī)定。 </p> <p> 備驗(yàn)證合格后即進(jìn)入設(shè)備初期使用階段，設(shè)備初期使用階段故障率較高。依據(jù)設(shè)備失效的浴盆曲線理論，設(shè)備失效狀態(tài)分三個(gè)階段：初期的失效高發(fā)期、設(shè)備運(yùn)行的穩(wěn)定期和后期的失效高發(fā)期。因此，設(shè)備移交時(shí)間的選擇應(yīng)在驗(yàn)證合格后、運(yùn)行進(jìn)入穩(wěn)定期后進(jìn)行，在設(shè)備管理中，該階段即是常說(shuō)的磨合期。設(shè)備如果在磨合期前移交，一旦發(fā)生故障，則較難進(jìn)行索賠。因此，設(shè)備初期應(yīng)較多的進(jìn)行運(yùn)行及空白物料試機(jī)，以使設(shè)備盡快進(jìn)入磨合期。在時(shí)間分布上，該階段還應(yīng)該在設(shè)備的索賠期限內(nèi)，即設(shè)備索賠期限至少達(dá)到設(shè)備的磨合期。湖北LIMS系統(tǒng)滅菌柜驗(yàn)證誠(chéng)信為先旦霆科技各類行業(yè)的驗(yàn)證服務(wù)經(jīng)驗(yàn)，專業(yè)為您提供滅菌柜驗(yàn)證，值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北GMP認(rèn)證滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295583876954/6963779.png"></div><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) </p><p> URS容易出現(xiàn)的問(wèn)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，不僅考慮工藝要求，而且考慮與GMP的符合性以及驗(yàn)證要求。旦霆科技可與客戶開(kāi)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)，提供滅菌柜驗(yàn)證等技術(shù)服務(wù)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖北GMP認(rèn)證滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295380234375/3887825.png"></div><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。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 /> 旦霆科技專業(yè)為國(guó)內(nèi)制藥行業(yè)提供滅菌柜驗(yàn)證服務(wù)、第三方測(cè)試執(zhí)行以及技術(shù)支持。湖北LIMS系統(tǒng)滅菌柜驗(yàn)證誠(chéng)信為先</p><p style="text-indent:25px">旦霆科技為提升各項(xiàng)目質(zhì)量水平，成立質(zhì)量部門。為滅菌柜驗(yàn)證等驗(yàn)證及檢測(cè)服務(wù)保駕護(hù)航！湖北GMP認(rèn)證滅菌柜驗(yàn)證第三方</p><p> 滅菌器驗(yàn)證程序 </p> <p> <br /> </p> <p> 安裝檢查 </p> <p> <br /> </p> <p> 1.1 安裝檢查所需文件的檢查： </p> <p> <br /> </p> <p> 1.1.1 高壓電熱壓力蒸汽消毒器使用說(shuō)明書的檢查：檢查是否有儀器的說(shuō)明書，說(shuō)明書與儀器是否配套。 </p> <p> <br /> </p> <p> 1.1.2 相關(guān)儀器儀表校驗(yàn)記錄的檢查：檢查校驗(yàn)記錄是否完整，是否定期進(jìn)行校驗(yàn)。 </p> <p> <br /> </p> <p> 1.1.3 高壓電熱壓力蒸汽消毒器使用標(biāo)準(zhǔn)操作規(guī)程的檢查：檢查是否具有相應(yīng)的標(biāo)準(zhǔn)操作規(guī)程。 </p> <p> <br /> </p> <p> 1.1.4 高壓電熱壓力蒸汽消毒器維修保養(yǎng)記錄的檢查：檢查儀器的維修保養(yǎng)記錄是否齊全，儀器是否定期進(jìn)行相應(yīng)的維修保養(yǎng)。 </p> <p> <br /> </p> <p> 1.1.5 高壓電熱壓力蒸汽消毒器使用記錄的檢查，檢查使用記錄是否完整。 </p> <p> <br /> </p> <p> <br /> 湖北GMP認(rèn)證滅菌柜驗(yàn)證第三方</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/3025321.html</p></div></div></div></div></div><div id="ajlifry" class="page-right twoColRt"><div id="fzw2skr" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="fzlnuw7" 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="8sp3fhy" class="recomPic likePro"><a 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