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src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431524472656/9507670.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="l5z5zpv" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431524472656/9507670.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="dj3j3zn" 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>四川干式細(xì)胞融化儀驗(yàn)證咨詢公司,驗(yàn)證咨詢公司</p><p><span>***更新：</span>2021-01-08 10:06:34</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="b3nj7nd" 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="pvlz5xf" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="7p5f5lr" class="box"><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(guò)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(guò)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(shuō)明。設(shè)計(jì)確認(rèn)執(zhí)行過(guò)程中可通過(guò)表格的方式對(duì)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(duì)，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(duì)相應(yīng)的設(shè)計(jì)文件進(jìn)行詳細(xì)索引，四川干式細(xì)胞融化儀驗(yàn)證咨詢公司，設(shè)計(jì)確認(rèn)過(guò)程中對(duì)于不能滿足的用戶需求應(yīng)進(jìn)行記錄，并通過(guò)評(píng)估以及與供應(yīng)商溝通的方式，四川干式細(xì)胞融化儀驗(yàn)證咨詢公司，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(jí)。經(jīng)過(guò)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)，四川干式細(xì)胞融化儀驗(yàn)證咨詢公司、性能確認(rèn)）的基礎(chǔ)。 </p> <p> <br /> </p> <p> <br /> 旦霆科技針對(duì)于中大型驗(yàn)證及測(cè)試項(xiàng)目均配備項(xiàng)目經(jīng)理，在為提供3Q認(rèn)證服務(wù)時(shí)及時(shí)匯報(bào)進(jìn)、嚴(yán)格控制質(zhì)量！四川干式細(xì)胞融化儀驗(yàn)證咨詢公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="四川干式細(xì)胞融化儀驗(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> 壓縮空氣系統(tǒng)驗(yàn)證內(nèi)容 </p> <p> 旦霆科技為企業(yè)提供壓縮空氣系統(tǒng)GMP驗(yàn)證咨詢，驗(yàn)證交付物包括VP，SC，SRA，IQ，OQ，PQ，RTM以及VSR文件,其中IQ內(nèi)容包括：文件確認(rèn)（圖紙確認(rèn)/技術(shù)文件確認(rèn)/材質(zhì)證明類(lèi)文件確認(rèn)/施工記錄/報(bào)告確認(rèn)）,系統(tǒng)安裝環(huán)境確認(rèn), 儀器儀表校準(zhǔn)確認(rèn),部件信息及安裝確認(rèn)，公用介質(zhì)連接確認(rèn), 標(biāo)識(shí)確認(rèn)；OQ內(nèi)容包含：系統(tǒng)啟動(dòng)和關(guān)閉，系統(tǒng)安全確認(rèn)，權(quán)限確認(rèn)，按鍵確認(rèn)，參數(shù)設(shè)置功能確認(rèn)，噪聲確認(rèn)，歷史故障記錄確認(rèn)，斷電/恢復(fù)確認(rèn)；PQ內(nèi)容包括：水分測(cè)試，含油量測(cè)試，固體顆粒測(cè)試以及微生物測(cè)試，測(cè)試執(zhí)行3次 </p> <p> <br /> </p> <p> <br /> 四川干式細(xì)胞融化儀驗(yàn)證咨詢公司旦霆科技配備幾百套驗(yàn)證及檢測(cè)儀器，專(zhuān)業(yè)的驗(yàn)證及檢測(cè)服務(wù)團(tuán)隊(duì)，專(zhuān)業(yè)提供驗(yàn)證服務(wù)，服務(wù)區(qū)域覆蓋全國(guó)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="四川干式細(xì)胞融化儀驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431525898437/6717066.png"></div><p> 1.IQ(安裝確認(rèn))：顧名思義就是對(duì)儀器的安裝過(guò)程進(jìn)行確認(rèn)(或驗(yàn)證)。 </p> <p> <br /> </p> <p> 首先是紙質(zhì)文件準(zhǔn)備，可以以表格的形式羅列出來(lái)，包括儀器廠家對(duì)儀器材質(zhì)、檢測(cè)等證明材料;儀器廠家的說(shuō)明書(shū)、包裝清單、配件清單等資料;使用部門(mén)編寫(xiě)的標(biāo)準(zhǔn)操作規(guī)程、維護(hù)保養(yǎng)記錄、使用記錄、人員培訓(xùn)等文件;儀表或其他部件的校正證明等等。 </p> <p> <br /> </p> <p> 其次是外界環(huán)境的準(zhǔn)備工作確認(rèn)，如房間排風(fēng)、溫濕度控制;電力供應(yīng)、意外停電應(yīng)急措施等。 </p> <p> <br /> </p> <p> ***就是儀器本身部件的確認(rèn)，根據(jù)說(shuō)明書(shū)和儀器本身的特點(diǎn)，核對(duì)以上準(zhǔn)備工作是否完成、是否合理。 </p> <p> <br /> </p><p> 什么是系統(tǒng)分類(lèi)（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(wèn)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(wèn)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(wú)法充分清潔、消毒或滅菌，從而給患者帶來(lái)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(duì)患者構(gòu)成風(fēng)險(xiǎn)或產(chǎn)品質(zhì)量下降? </p> <p> <br /> 旦霆科技作為專(zhuān)業(yè)的CSV驗(yàn)證及第三方檢測(cè)供應(yīng)商，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)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="四川干式細(xì)胞融化儀驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431490947265/9085575.png"></div><p> 什么是驗(yàn)證總結(jié)報(bào)告，怎么做？ </p> <p> 在GMP驗(yàn)證咨詢服務(wù)確認(rèn)程序的** 后階段應(yīng)完成確認(rèn)總結(jié)報(bào)告。這個(gè)報(bào)告的目的是總結(jié)和**終審核所有可能存在問(wèn)題的確認(rèn)活動(dòng)以及出現(xiàn)的偏差。確認(rèn)總結(jié)報(bào)告** 后，應(yīng)正式說(shuō)明系統(tǒng)準(zhǔn)予放行，可進(jìn)行GMP相關(guān)的生產(chǎn)活動(dòng)。滿足以下條件，本系統(tǒng)即可批準(zhǔn)正式放行： </p> <p> 1. 所有的測(cè)試均執(zhí)行完成，所有的確認(rèn)報(bào)告（DQ, CCA,RA,IQ, OQ, PQ）被批準(zhǔn)； </p> <p> 2. 如有必要，應(yīng)通過(guò)追蹤矩陣、檢查清單等方式證實(shí)所有的URS已得到滿足； </p> <p> 3. 所有的偏差均被糾正和關(guān)閉； </p> <p> 4. 如果只有微小偏差沒(méi)有關(guān)閉，只能生成一個(gè)臨時(shí)的總結(jié)報(bào)告，這種情況下可以接受該系統(tǒng)限制性放行，并可用于GMP操作。當(dāng)所有偏差被關(guān)閉后，批準(zhǔn)**終的驗(yàn)證總結(jié)報(bào)告； </p> <p> 當(dāng)每個(gè)系統(tǒng)驗(yàn)證總結(jié)報(bào)告均被批準(zhǔn)之后，整個(gè)項(xiàng)目的確認(rèn)活動(dòng)宣告完成，并可以投入應(yīng)用于GMP相關(guān)的生產(chǎn)操作。在驗(yàn)證主報(bào)告中應(yīng)該描述性的總結(jié)所有相關(guān)系統(tǒng)的狀況，確保沒(méi)有遺漏任何一個(gè)GMP相關(guān)或生物安全相關(guān)的系統(tǒng). 旦霆科技可提供CSV認(rèn)證等驗(yàn)證檢測(cè)服務(wù)。廣納良言，吸取客戶有效意見(jiàn)、致力于為客戶更好的服務(wù)。四川干式細(xì)胞融化儀驗(yàn)證咨詢公司</p><p style="text-indent:25px">旦霆科技感恩新老客戶的多年信賴，我們將再接再厲，持續(xù)為新老客戶提供質(zhì)量、專(zhuān)業(yè)的CSV驗(yàn)證服務(wù)！四川干式細(xì)胞融化儀驗(yàn)證咨詢公司</p><p> 旦霆科技為企業(yè)提供消毒劑消毒效果驗(yàn)證GMP驗(yàn)證咨詢，實(shí)驗(yàn)室對(duì)消毒劑的殺菌效力測(cè)定方法常有定量懸浮試驗(yàn)法、載體浸泡定量試驗(yàn)法、表面試驗(yàn)法、工作液直接接種法等多種試驗(yàn) 方法；現(xiàn) 場(chǎng) 考察試驗(yàn) 用以評(píng) 估消毒劑對(duì)相應(yīng)設(shè)施的實(shí)際消毒效力，如潔凈區(qū)的墻面、天花板、門(mén)窗、機(jī)器設(shè)備、儀器、操作臺(tái)、地漏、推車(chē)、桌椅等表面以及操作人員雙手（手套）。此類(lèi) 試驗(yàn) 是通過(guò) 監(jiān) 測(cè) 清潔<span style="display:none;"></span>（消毒）前后的環(huán) 境微生物質(zhì) 量進(jìn) 行的。經(jīng) 歷一段時(shí) 間后才能積累用以評(píng)估消毒和淸潔程序的數(shù) 據(jù) （建議至少 3 次試驗(yàn) ）通常在 ** 差條件 ( 如預(yù) 防性維修之后）檢驗(yàn) 環(huán) 境的污染狀況，因?yàn)榇藭r(shí) 環(huán) 境中的微生物種類(lèi) 和數(shù) 量有上升的潛在可能 ***廠常見(jiàn)消毒劑有如下幾種：75%乙醇、0.1%新潔爾滅溶液、0.3%新潔爾滅溶液、0.1%醋酸洗必泰、0.5%醋酸洗必泰、40mg/L的二氧化氯、60mg/L的二氧化氯，消毒劑效果驗(yàn)證一般分為實(shí)驗(yàn)室考察部分和現(xiàn)場(chǎng)考察部分，四川干式細(xì)胞融化儀驗(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(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://m.cdcfah.com/cp/2757814.html</p></div></div></div></div></div><div id="rxvjn7f" class="page-right twoColRt"><div id="d577dtj" class="box01 margin10 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