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class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431524472656/5236721.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="lrczrv8" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431524472656/5236721.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="ayfmovp" class="content"><p><span>需求數(shù)量：</span>0</p><p><span>價格要求：</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>重慶穩(wěn)定性試驗(yàn)箱驗(yàn)證咨詢公司,驗(yàn)證咨詢公司</p><p><span>***更新：</span>2020-08-09 17:04:30</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="c7a2b93" 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="wgspmoq" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="tx3zqce" class="box"><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> <p> 旦霆科技為企業(yè)提供生物制品工藝驗(yàn)證GMP驗(yàn)證咨詢，按照工藝流程： </p> <p> 細(xì)胞庫制備及保存設(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)蘇過程：水浴鍋，生物安全柜，重慶穩(wěn)定性試驗(yàn)箱驗(yàn)證咨詢公司，恒溫培養(yǎng)箱，搖床，CO2培養(yǎng)箱等； </p> <p> 細(xì)胞培養(yǎng)、傳代過程：生物反應(yīng)器； </p> <p> 收貨過程：過濾系統(tǒng)，收集罐，中轉(zhuǎn)罐等； </p> <p> 純化和精制過程：離心機(jī)，層析系統(tǒng)（蛋白純化柱，重慶穩(wěn)定性試驗(yàn)箱驗(yàn)證咨詢公司，GE AKTA蛋白純化儀等）過濾系統(tǒng)，除菌過濾系統(tǒng)；旦霆科技可與客戶開展遠(yuǎn)程技術(shù)交流，重慶穩(wěn)定性試驗(yàn)箱驗(yàn)證咨詢公司，解決難題為雙方良好合作打下扎實(shí)基礎(chǔ)，提供csv驗(yàn)證等技術(shù)服務(wù)。重慶穩(wěn)定性試驗(yàn)箱驗(yàn)證咨詢公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="重慶穩(wěn)定性試驗(yàn)箱驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431524472656/5236721.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> <br /> </p> <p> 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驗(yàn)證咨詢。在藥品生產(chǎn) 的每道工序完成后，對制藥設(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。重慶穩(wěn)定性試驗(yàn)箱驗(yàn)證咨詢公司旦霆科技作為國內(nèi)為數(shù)不多的中大規(guī)模驗(yàn)證公司，專業(yè)提供CSV驗(yàn)證服務(wù)，擁有幾十人的驗(yàn)證團(tuán)隊(duì)，值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="重慶穩(wěn)定性試驗(yàn)箱驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431513242187/8526534.jpg"></div><p> 制藥用水系統(tǒng)驗(yàn)證內(nèi)容 </p> <p> 旦霆科技為企業(yè)提供制藥用水系統(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)證明類文件確認(rèn)/施工記錄/報告確認(rèn)）, 系統(tǒng)安全確認(rèn), 系統(tǒng)安裝環(huán)境確認(rèn), 公用介質(zhì)連接確認(rèn), 儀器儀表校準(zhǔn)確認(rèn), 機(jī)械部件安裝確認(rèn)，HMI及PLC確認(rèn)，標(biāo)識確認(rèn)，I/O測試確認(rèn)；OQ內(nèi)容包括：系統(tǒng)啟動和關(guān)閉確認(rèn)，登錄權(quán)限確認(rèn)，HMI界面和基本功能確認(rèn)，用戶權(quán)限確認(rèn)，控制柜急停功能確認(rèn)，電機(jī)轉(zhuǎn)向確認(rèn)，罐體排空確認(rèn)，核黃素覆蓋率確認(rèn)，預(yù)處理清洗、消毒功能確認(rèn)，軟化器自動再生功能確認(rèn)，反滲透自動沖洗功能確認(rèn)，自動程序運(yùn)行確認(rèn)，純化水流速及產(chǎn)能確認(rèn)，電加熱空氣呼吸器（保溫純化水箱）加熱功能確認(rèn)，紫外滅菌器計(jì)時功能確認(rèn)，反滲透系統(tǒng)消毒功能確認(rèn)，純化水分配系統(tǒng)消毒功能確認(rèn)，純化水關(guān)鍵控制點(diǎn)取樣確認(rèn)，用戶權(quán)限確認(rèn)，互鎖/安全確認(rèn)，報警確認(rèn)，斷電恢復(fù)確認(rèn)，數(shù)據(jù)打印功能確認(rèn)；PQ內(nèi)容包括：第1階段（評價階段），第2階段（短期質(zhì)量控制階段），第三階段（長期質(zhì)量控制階段）分別對制備系統(tǒng)各過程控制點(diǎn)和分配系統(tǒng)各取樣點(diǎn)進(jìn)行取樣檢測 </p> <p> <br /> </p><p> 各項(xiàng)驗(yàn)證與測試 </p> <p> <br /> </p> <p> 在各項(xiàng)驗(yàn)證中，確認(rèn)儀器的個別或整體性能，必須對儀器進(jìn)行各項(xiàng)測試，測試是指系統(tǒng)中誤差的鑒定，當(dāng)我們用已知(亦即可回溯)的標(biāo)準(zhǔn)品對儀器進(jìn)行測試時，這個過程就稱之為校正。 </p> <p> <br /> </p> <p> 倘若鑒定后的誤差超出容許的范圍，就必須視情況對儀器進(jìn)行調(diào)整的動作，并將原來偏差的部分調(diào)回標(biāo)準(zhǔn)的規(guī)格，這個過程我們可稱之為標(biāo)準(zhǔn)化。 </p> <p> <br /> </p> <p> 因此，儀器在驗(yàn)證的過程中必須作哪些測試，必須選擇什么樣的標(biāo)準(zhǔn)品，就成為相當(dāng)重要的課題。 </p> <p> <br /> </p> <p> 在各類檢測規(guī)范中，雖然對于分析儀器驗(yàn)證的項(xiàng)目及其標(biāo)準(zhǔn)，有部分建議及規(guī)范供使用者遵循，但規(guī)范多是概念性的指引，對于詳細(xì)的驗(yàn)證程序著墨不多，在驗(yàn)證中，需根據(jù)現(xiàn)實(shí)情況做調(diào)整。 </p> <p> <br /> </p> <p> <br /> 旦霆科技不忘初心，持續(xù)資助中國貧困兒童教育的同時，持續(xù)以高性價比為國內(nèi)企業(yè)提供CSV驗(yàn)證與咨詢服務(wù).</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="重慶穩(wěn)定性試驗(yàn)箱驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431512958984/46711.jpg"></div><p> 倉儲物流系統(tǒng)簡介 </p> <p> 旦霆科技為企業(yè)提供倉儲物流系統(tǒng)GMP驗(yàn)證咨詢，制藥企業(yè) 的產(chǎn) 品通過生產(chǎn) 、存儲、運(yùn) 輸及交付，**終才能到達(dá)患者的手中，為保證患者的安全，如何對制<span style="display:none;"></span>藥企業(yè) 的倉儲物流系統(tǒng) 進(jìn) 行驗(yàn) 證成為關(guān) 注的重點(diǎn) 問題。ICHQ7，《美國藥典》，中國GMP2010版都對藥品的倉儲物流系統(tǒng)提出了相應(yīng)的法規(guī)需求。ISPE<span style="display:none;"></span>冷鏈管理中對藥品的冷鏈則提出了具體的質(zhì)量計(jì)劃，從倉儲運(yùn)輸做出了具體規(guī)劃： </p> <p> 1.廠房管理：包括培訓(xùn)，清潔，維護(hù)，蟲害控制以及安全； </p> <p> 2. 對以下幾類物料存儲條件的管理：包裝物料，印刷物料，產(chǎn)品潛在危害物質(zhì)，合格物料，待檢物料，不合格物料等，以及對物料存儲的存貨單控制/記錄和管理流程的建立（包括培訓(xùn)，接收和發(fā)貨）等； </p> <p> 3.對溫度受控區(qū)域的控制：規(guī)范要求，產(chǎn)品數(shù)據(jù)，相應(yīng)的清潔，維護(hù)，校準(zhǔn)，確認(rèn)，監(jiān)控，報警流程，廢料處理等， </p> <p> 4.運(yùn)輸：運(yùn)輸方法的制定和驗(yàn)證，供應(yīng) 商審計(jì)，供應(yīng) 商性能確認(rèn) / 監(jiān) 測，貨物檢測 / 性能監(jiān) 測等等。旦霆科技成立至今為超過800多家企業(yè)提供GMP咨詢、CSV驗(yàn)證等服務(wù)，口碑良好，性價比高！陜西層流罩驗(yàn)證咨詢公司</p><p style="text-indent:25px">旦霆科技成員具備多年工作經(jīng)驗(yàn)、良好的GMP理念、熟悉精通國內(nèi)外相關(guān)法規(guī)，可專業(yè)開展CSV驗(yàn)證服務(wù)！重慶穩(wěn)定性試驗(yàn)箱驗(yàn)證咨詢公司</p><p> 分析方法驗(yàn)證怎么做？ </p> <p> 旦霆科技為企業(yè)提供分析方法驗(yàn)證GMP驗(yàn)證咨詢。分析方法驗(yàn)證的目的是證明所采用的方法達(dá)到相應(yīng)的檢測要求，驗(yàn)證的內(nèi)容主要包括準(zhǔn)確度、精密度、專屬性、檢測限、定量限、線性、范圍、粗放性（重現(xiàn)性）和耐用性9個方面。某一方法需到底須進(jìn)行哪些項(xiàng)目的驗(yàn)證，應(yīng)根據(jù)實(shí)際情況而定，一般可分一下3種情況對待： </p> <p> 1. 對于直接引用有法定依據(jù)的方法，如藥典標(biāo)準(zhǔn)和部頒標(biāo)準(zhǔn)，*做系統(tǒng)適用性試驗(yàn)即可。但若將法定方法用于測定新藥，或?qū)⒛骋黄贩N的法定測定方法用于另一品種，就需進(jìn)行系統(tǒng)的方法驗(yàn)證。 </p> <p> 2. 對于已在一實(shí)驗(yàn)室驗(yàn)證過但需在另一個實(shí)驗(yàn)室使用的分析方法，可采用對照試驗(yàn)法。即取同一批樣品，按此方法在兩實(shí)驗(yàn)室分別進(jìn)行檢驗(yàn)，將結(jié)果進(jìn)行比較 ( </p> <p> 如用 t 檢驗(yàn)法計(jì)算 ) ，判斷是否有性差異。其他分析方法又分為4種類型，有不同的驗(yàn)證要求：用于測定原料藥中主要成分或制劑中活性組分 ( 包括防腐劑 ) </p> <p> 的定量分析方法；用于測定原料藥中雜質(zhì)或制劑中降解產(chǎn)物的分析方法，包括定量分析和限度試驗(yàn)；用于測定性能特性 ( 如溶解度、溶出度 ) </p> <p> 的分析方法以及鑒別試驗(yàn) </p> <p> <br /> </p> <p> </p> <p> <br /> </p> <p> 重慶穩(wěn)定性試驗(yàn)箱驗(yàn)證咨詢公司</p><p style="text-indent:25px">旦霆生物科技（上海）有限公司一直專注于旦霆生物科技（上海）有限公司位于上海市青浦區(qū)徐涇鎮(zhèn)華徐公路966號323室、325室，成立于2014年04月21日的私營/民營企業(yè)，目前公司的主要經(jīng)營范圍是從事生物科技、計(jì)算機(jī)領(lǐng)域內(nèi)的技術(shù)開發(fā)、技術(shù)咨詢,企業(yè)管理咨詢,檢測領(lǐng)域內(nèi)的技術(shù)咨詢和技術(shù)服務(wù)?！疽婪毥?jīng)批準(zhǔn)的項(xiàng)目,經(jīng)相關(guān)部門批準(zhǔn)后方可開展經(jīng)營活動】，是一家醫(yī)藥、保養(yǎng)的企業(yè)，擁有自己**的技術(shù)體系。公司目前擁有11~50人員工，為員工提供廣闊的發(fā)展平臺與成長空間，為客戶提供高質(zhì)高效的產(chǎn)品服務(wù)，深受員工與客戶好評。公司業(yè)務(wù)范圍主要包括：[ "GMP驗(yàn)證咨詢與服務(wù)", "計(jì)算機(jī)化系統(tǒng)驗(yàn)證", "壓縮空氣檢測", "潔凈室檢測" ]等。公司奉行顧客至上、質(zhì)量為首、的經(jīng)營宗旨，深受客戶好評。公司力求給客戶提供***質(zhì)量服務(wù)，我們相信誠實(shí)正直、開拓進(jìn)取地為公司發(fā)展做正確的事情，將為公司和個人帶來共同的利益和進(jìn)步。經(jīng)過幾年的發(fā)展，已成為[ "GMP驗(yàn)證咨詢與服務(wù)", "計(jì)算機(jī)化系統(tǒng)驗(yàn)證", "壓縮空氣檢測", "潔凈室檢測" ]行業(yè)**企業(yè)。</p></p><br /><p>文章來源地址: http://m.cdcfah.com/cp/861288.html</p></div></div></div></div></div><div id="wu4oqxu" class="page-right twoColRt"><div id="qzol3oa" class="box01 margin10 clearfix"><h3><a 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