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onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="rlda82r" 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>浙江GMP咨詢值得推薦,GMP咨詢</p><p><span>***更新：</span>2021-01-18 03:05:18</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="wqnpr32" 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="3ibv3if" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="vz7xeln" class="box"><p><p> 什么是需求追溯矩陣，怎么做？ </p> <p> <br /> </p> <p> ISPE GAMP5《良好自動(dòng)化生產(chǎn)實(shí)踐指南-遵從GxP計(jì)算機(jī)化系統(tǒng)監(jiān)管的風(fēng)險(xiǎn)管理方法》提到：在系統(tǒng)生命周期的早期就應(yīng)該識(shí)別并糾正系統(tǒng)缺點(diǎn)，設(shè)計(jì)審査和可追溯性有助于保證系統(tǒng)符合預(yù)定用途，并且可以通過(guò)在早期識(shí)別缺陷并解決問(wèn)題來(lái)降低總體項(xiàng)目成本?！?GMP咨詢過(guò)程中，需求追溯性矩陣（Requirements traceability matrix, RTM)可與標(biāo)準(zhǔn)、要點(diǎn)和成果進(jìn)行比較，對(duì)特定問(wèn)題點(diǎn)提出必要的糾正措施。 </p> <p> 需求追溯矩陣可起到如下作用： </p> <p> 1.設(shè)計(jì)需求經(jīng)過(guò)了驗(yàn)證，并可以追溯到表明需求得到滿足的測(cè)試或驗(yàn)證活動(dòng)； </p> <p> 2.使得風(fēng)險(xiǎn)管理和設(shè)計(jì)審査流程更有效率； </p> <p> 判斷所提交的變更需求會(huì)產(chǎn)生什么樣的影響； </p> <p> 3.有助于對(duì)所提交的變更進(jìn)行風(fēng)險(xiǎn)評(píng)估； </p> <p> 4.確認(rèn)對(duì)變更進(jìn)行測(cè)試的范圍； </p> <p> 5，浙江GMP咨詢值得推薦.可在檢査和審査時(shí)快速準(zhǔn)確地反應(yīng)。 </p> <p> <br /> 旦霆科技成員具備10年以上工作經(jīng)驗(yàn)，浙江GMP咨詢值得推薦，浙江GMP咨詢值得推薦、良好的GMP理念、精通國(guó)內(nèi)外相關(guān)法規(guī)，可專業(yè)開(kāi)展GMP咨詢服務(wù)！浙江GMP咨詢值得推薦</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="浙江GMP咨詢值得推薦,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312263828125/6888947.jpg"></div><p> 什么是驗(yàn)證與確認(rèn)？ </p> <p> <p> 3Q驗(yàn)證/3Q認(rèn)證/驗(yàn)證與確認(rèn)是證明任何程序、生產(chǎn)過(guò)程、設(shè)備、物料、活動(dòng)或系統(tǒng)確實(shí)能達(dá)到預(yù)期結(jié)果的有文件證明的一系列活動(dòng)，PIC/s中將驗(yàn)證與確認(rèn)的關(guān)系闡釋如下：設(shè)計(jì)確認(rèn)-安裝確認(rèn)-運(yùn)行確認(rèn)-工藝驗(yàn)證(性能確認(rèn))-變更控制-設(shè)計(jì)確認(rèn)。 </p> <p> 設(shè)備/系統(tǒng)的確認(rèn)/驗(yàn)證工作應(yīng)按照驗(yàn)證生命周期（Life cycle）設(shè)計(jì)出一套完整的驗(yàn)證計(jì)劃（VP）及有效的測(cè)試策略，旦霆科技為您提供GMP咨詢，從制定用戶需求說(shuō)明為起點(diǎn)，經(jīng)過(guò)設(shè)計(jì)階段，建造實(shí)施階段，安裝確認(rèn)，運(yùn)行確認(rèn)，**終通過(guò)性能確認(rèn)來(lái)證實(shí)用戶需求說(shuō)明是否完成。 </p> 浙江GMP咨詢值得推薦旦霆科技擁有專業(yè)的驗(yàn)證團(tuán)隊(duì)，專業(yè)的驗(yàn)證設(shè)備，為您提供專業(yè)、質(zhì)量的GMP咨詢服務(wù)！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="浙江GMP咨詢值得推薦,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312262080078/3685544.jpg"></div><p> 清潔驗(yàn)證方案制定應(yīng)重點(diǎn)考慮以下內(nèi)容： </p> <p> 1．參照物質(zhì)與**難清潔物質(zhì)選擇； </p> <p> 2． **難清潔部位和取樣點(diǎn)選擇； </p> <p> 3．殘留物限度的確定 </p> <p> 4．殘留溶劑的限度標(biāo)準(zhǔn) </p> <p> 5．微生物污染控制標(biāo)準(zhǔn) </p> <p> 6. 取樣與檢驗(yàn)方法學(xué) </p> <p> 旦霆科技為企業(yè)提供清潔驗(yàn)證方案GMP咨詢。在藥品生產(chǎn) 的每道工序完成后，對(duì) 制藥設(shè) 備進(jìn) 行淸洗是防止藥品污染和交叉污染的必要手段, 嚴(yán) 格地講，*** 意義上的、不含任何殘留物的清潔狀態(tài) 是不存在的, 設(shè) 備的清潔程度，取決于殘留物的性質(zhì) 、設(shè) 備的結(jié) 構(gòu) 、材質(zhì) 和清洗的方法。 </p> <p> <br /> </p><p> 旦霆科技為企業(yè)提供消毒劑消毒效果驗(yàn)證，此類試驗(yàn) 是通過(guò) 監(jiān) 測(cè) 清潔（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，因為此時(shí) 環(huán) 境中的微生物種類和數(shù) 量有上升的潛在可能性， </p> <p> 旦霆科技為企業(yè)提供消毒劑消毒效果驗(yàn)證GMP咨詢，藥廠常見(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，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、門窗、機(jī)器設(shè)備、儀器、操作臺(tái)、地漏、推車、桌椅等表面以及操作人員雙手（手套）。旦霆科技作為專業(yè)的GMP咨詢、第三方檢測(cè)供應(yīng)商，配備國(guó)外專業(yè)驗(yàn)證及檢測(cè)儀器,質(zhì)量可靠值得推薦!</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="浙江GMP咨詢值得推薦,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312036142578/5616514.jpg"></div><p> 清潔驗(yàn)證 </p> <p> <p> 旦霆科技為企業(yè)提供清潔驗(yàn)證方案GMP咨詢。在藥品生產(chǎn) 的每道工序完成后，對(duì) 制藥設(shè) 備進(jìn) 行淸洗是防止藥品污染和交叉污染的必要手段, 嚴(yán) 格地講，*** 意義上的、不含任何殘留物的清潔狀態(tài) 是不存在的, 設(shè) 備的清潔程度，取決于殘留物的性質(zhì) 、設(shè) 備的結(jié) 構(gòu) 、材質(zhì) 和清洗的方法。清潔驗(yàn)證方案制定應(yīng)重點(diǎn)考慮以下內(nèi)容： </p> <p> 1．參照物質(zhì)與**難清潔物質(zhì)選擇； </p> <p> 2． **難清潔部位和取樣點(diǎn)選擇； </p> <p> 3．殘留物限度的確定 </p> <p> 4．殘留溶劑的限度標(biāo)準(zhǔn) </p> <p> 5．微生物污染控制標(biāo)準(zhǔn) </p> <p> 取樣與檢驗(yàn)方法學(xué) </p> 旦霆科技團(tuán)隊(duì)成員精通、掌握國(guó)內(nèi)為GMP、國(guó)標(biāo)、ISO、ISPE等相關(guān)法規(guī)，可為相關(guān)企業(yè)開(kāi)展GMP咨詢等服務(wù)。貴州環(huán)境監(jiān)測(cè)系統(tǒng)驗(yàn)證GMP咨詢</p><p style="text-indent:25px">旦霆科技具備新建企業(yè)整場(chǎng)驗(yàn)證及檢測(cè)的實(shí)力，可有效開(kāi)展GMP咨詢及相關(guān)驗(yàn)證或檢測(cè)服務(wù)！浙江GMP咨詢值得推薦</p><p> 生物制品工藝設(shè)備 </p> <p> <p> 旦霆科技為企業(yè)提供生物制品工藝驗(yàn)證GMP咨詢，按照工藝流程： </p> <p> 細(xì)胞庫(kù)制備及保存設(shè)備：液氮罐，超低溫冰箱，搖床，培養(yǎng)箱，倒置顯微鏡，生化分析儀，細(xì)胞計(jì)數(shù)儀，流式細(xì)胞儀，程序降溫儀等； </p> <p> 細(xì)胞復(fù)蘇過(guò)程：水浴鍋，生物安全柜，恒溫培養(yǎng)箱，搖床，CO2培養(yǎng)箱等； </p> <p> 細(xì)胞培養(yǎng)、傳代過(guò)程：生物反應(yīng)器； </p> <p> 收貨過(guò)程：過(guò)濾系統(tǒng)，收集罐，中轉(zhuǎn)罐等； </p> <p> 純化和精制過(guò)程：離心機(jī)，層析系統(tǒng)（蛋白純化柱，GE AKTA蛋白純化儀等）過(guò)濾系統(tǒng)，除菌過(guò)濾系統(tǒng)； </p> <p> 生物制品生產(chǎn)設(shè)備和系統(tǒng)中一般被定義為直接影響系統(tǒng)的有： </p> <p> 1. 配液罐系統(tǒng) </p> <p> 2. 反應(yīng)罐系統(tǒng) </p> <p> 3. 超濾系統(tǒng) </p> <p> 離心機(jī)系統(tǒng) </p> 浙江GMP咨詢值得推薦</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/2893456.html</p></div></div></div></div></div><div id="3vcegi8" class="page-right twoColRt"><div id="8f3qnzb" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="mg7c8d8" 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" 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