云南微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司創(chuàng)新服務(wù) 旦霆生物科技供應(yīng)-b2b網(wǎng)站_b2b電子商務(wù)平臺【買產(chǎn)品】-上?？谄蚴称酚邢薰?/title><meta name="description" content="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：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：1.配液罐系統(tǒng)2.反應(yīng)罐系統(tǒng)3.超濾系統(tǒng)4.離心機(jī)系統(tǒng)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，"><meta name="keywords" content="云南微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司,驗(yàn)證咨詢公司"><link rel="canonical" href="http://www.cdcfah.com/"/><meta name="applicable-device" content="pc"><link rel="shortcut icon" href="/static/new_net_01/images/favicon.ico"><link rel="stylesheet" href="/static/new_net_01/css/slick.css" /><link rel="stylesheet" href="/static/new_net_01/css/addnew.css"><link rel="stylesheet" href="/static/new_net_01/css/sidenav.css"><link rel="stylesheet" href="/static/new_net_01/css/style.css" /><link rel="stylesheet" href="/static/new_net_01/css/tab.css"><link rel="stylesheet" href="/static/new_net_01/css/404.css"> <meta 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href="http://www.cdcfah.com/cp/third-swzp_qtswzp/">其他生物制品</a>?云南微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司創(chuàng)新服務(wù) 旦霆生物科技供應(yīng)</p><div id="iu89oqv" class="leftbox clearfix"><h1>云南微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司創(chuàng)新服務(wù) 旦霆生物科技供應(yīng)</h1><div id="qfczwda" class="proBig"><div id="nrjgd3g" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431525859375/4595948.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="lqskrtv" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431525859375/4595948.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="she2zgd" 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>云南微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司,驗(yàn)證咨詢公司</p><p><span>***更新：</span>2021-01-26 04:05:13</p><p><span id="click" >瀏覽次數(shù)：1次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="34r3df2" 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="srdqnur" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="o3g92og" class="box"><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> 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> 4.離心機(jī)系統(tǒng) </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，云南微生物實(shí)驗(yàn)室驗(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，云南微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司，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，GE AKTA蛋白純化儀等）過濾系統(tǒng)，除菌過濾系統(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，云南微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司. 超濾系統(tǒng) </p> <p> 離心機(jī)系統(tǒng) 旦霆科技配備數(shù)十人的驗(yàn)證及檢測團(tuán)隊(duì)，承接國內(nèi)各類相關(guān)企業(yè)的CSV驗(yàn)證、第三方驗(yàn)證或檢測及咨詢服務(wù)。云南微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="云南微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431525859375/4595948.jpg"></div><p> "回顧性驗(yàn)證怎么做 </p> <p> <br /> </p> <p> GMP驗(yàn)證咨詢服務(wù)中，回顧驗(yàn)證必須具備以下條件方可應(yīng)用： </p> <p> <br /> </p> <p> 1.至少有6批符合要求的數(shù)據(jù)，有20批以上的數(shù)據(jù)更好。 </p> <p> <br /> </p> <p> 2.檢驗(yàn)方法已經(jīng)過驗(yàn)證，檢驗(yàn)的結(jié)果可以用數(shù)值表示，可以進(jìn)行統(tǒng)計(jì)分析。 </p> <p> <br /> </p> <p> 3.批記錄符合制藥GMP要求，記錄中有明確的工藝條件，且有關(guān)于偏差的分析說明。 </p> <p> <br /> </p> <p> 4.有關(guān)的工藝變量是標(biāo)準(zhǔn)化的，并一直處于控制狀態(tài)，如原料標(biāo)準(zhǔn)、潔凈區(qū)的級別、分析方法、微生物控制等。 </p> <p> <br /> </p> <p> 5.這種方式通常用于非無菌產(chǎn)品的工藝驗(yàn)證，以積累的生產(chǎn)、檢驗(yàn)和其他有關(guān)歷史資料為依據(jù)，回顧、分析工藝控制的全過程，證實(shí)其控制條件的有效件。" </p> <p> <br /> 云南微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司旦霆科技不但擁有龐大的驗(yàn)證及檢測團(tuán)隊(duì)，同時配備幾百套驗(yàn)證及檢測儀器，專業(yè)開展CSV驗(yàn)證服務(wù)！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="云南微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431491279297/3059290.png"></div><p> 我司目前已提供以下常見實(shí)驗(yàn)室儀器{3Q驗(yàn)GMP驗(yàn)證咨詢服務(wù)： </p> <p> 存儲類：冷藏箱，低溫冰箱，超低溫冰箱，液氮儲存罐，程序降溫儀 </p> <p> 其他類:CO2培養(yǎng)箱，生化培養(yǎng)箱，震蕩培養(yǎng)箱，電熱鼓風(fēng)干燥箱，生物安全柜，超凈工作臺，通風(fēng)櫥、層流罩、手套箱、隔離器，離心機(jī)（冷凍，微量，96孔板），水浴槽，全自動蛋白純化儀，純水儀，洗板機(jī)，滅菌鍋，干式細(xì)胞融化儀，血液分析系統(tǒng) </p> <p> 生化檢測類：細(xì)胞計(jì)數(shù)儀，流式細(xì)胞儀實(shí)時熒光定量PCR儀，全自動微生物培養(yǎng)系統(tǒng)，酶標(biāo)儀，凝膠成像系統(tǒng)，倒置顯微鏡，菌落計(jì)數(shù)器 </p> <p> 理化檢測類：電泳儀，電導(dǎo)率儀，紫外分光光度計(jì)，紅外分光光度計(jì)，可見分光光度計(jì)，高效液相色譜儀，氣相色譜儀，原子吸收光譜儀、質(zhì)譜儀，液質(zhì)聯(lián)用/氣質(zhì)聯(lián)用，滲透壓儀，pH計(jì)，分析天平/電子天平，血細(xì)胞分析儀 </p> <p> <br /> </p> <p> </p> <p> <br /> </p> <p> </p><p> 工藝驗(yàn)證是什么，怎么做？ </p> <p> 旦霆科技為企業(yè)提供工藝驗(yàn)證GMP驗(yàn)證咨詢。工藝驗(yàn)證應(yīng)當(dāng)證明一個生產(chǎn)工藝按照規(guī)定的工藝參數(shù)能夠持續(xù)生產(chǎn)出符合預(yù)定用途和注冊要求的產(chǎn)品。在工藝驗(yàn)證之前應(yīng)確定以下工作已完成: </p> <p> 1.所使用的設(shè)備或設(shè)施已完成安裝確認(rèn) (IQ) ，運(yùn)行確認(rèn) (OQ) 和性能確認(rèn)（PQ）； </p> <p> 2.產(chǎn)品的質(zhì)量標(biāo)準(zhǔn)已確定； </p> <p> 3.分析方法驗(yàn)證已完成； </p> <p> 工藝驗(yàn)證一般要求生產(chǎn)至少連續(xù)3批，對于新產(chǎn)品的工藝驗(yàn)證，由于產(chǎn)品產(chǎn)品從小試成功，中試放大，再到商業(yè)化生產(chǎn)中一些工藝參數(shù)還不能確定，因此推薦先進(jìn)行至少1個批號的開發(fā)批工藝驗(yàn)證，跟進(jìn)此次數(shù)據(jù)調(diào)整一些工藝參數(shù)和設(shè)備操作，為正式工藝驗(yàn)證提供可靠數(shù)據(jù)基礎(chǔ)，但開發(fā)批的產(chǎn)品必須檢驗(yàn)全部符合質(zhì)量標(biāo)準(zhǔn)，且偏差得到有效調(diào)查評估后才可關(guān)閉。根據(jù)開發(fā)批驗(yàn)證的數(shù)據(jù)修改SOP，并起草工藝驗(yàn)證方案。 </p> <p> <br /> 旦霆科技作為專業(yè)的CSV驗(yàn)證及第三方檢測供應(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。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="云南微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431513007812/9123788.jpg"></div><p> 制藥行業(yè)實(shí)驗(yàn)室常見儀器清單 </p> <p> <br /> </p> <p> 我司目前已提供以下常見實(shí)驗(yàn)室儀器GMP驗(yàn)證咨詢服務(wù)： </p> <p> <br /> </p> <p> 生化檢測類：細(xì)胞計(jì)數(shù)儀，流式細(xì)胞儀實(shí)時熒光定量PCR儀，全自動微生物培養(yǎng)系統(tǒng)，酶標(biāo)儀，凝膠成像系統(tǒng)，倒置顯微鏡，菌落計(jì)數(shù)器 </p> <p> <br /> </p> <p> 理化檢測類：電泳儀，電導(dǎo)率儀，紫外分光光度計(jì)，紅外分光光度計(jì)，可見分光光度計(jì)，高效液相色譜儀，氣相色譜儀，原子吸收光譜儀、質(zhì)譜儀，液質(zhì)聯(lián)用/氣質(zhì)聯(lián)用，滲透壓儀，pH計(jì)，分析天平/電子天平，血細(xì)胞分析儀 </p> <p> <br /> </p> <p> 存儲類：冷藏箱，低溫冰箱，超低溫冰箱，液氮儲存罐，程序降溫儀 </p> <p> <br /> </p> <p> 其他類: CO2培養(yǎng)箱，生化培養(yǎng)箱，震蕩培養(yǎng)箱，電熱鼓風(fēng)干燥箱，生物安全柜，超凈工作臺，通風(fēng)櫥、層流罩、手套箱、隔離器，離心機(jī)（冷凍，微量，96孔板），水浴槽，全自動蛋白純化儀，純水儀，洗板機(jī)，滅菌鍋，干式細(xì)胞融化儀，血液分析系統(tǒng) </p> <p> <br /> 旦霆科技可提供CSV認(rèn)證等驗(yàn)證檢測服務(wù)。廣納良言，吸取客戶有效意見、致力于為客戶更好的服務(wù)。云南微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司</p><p style="text-indent:25px">旦霆科技針對于中大型驗(yàn)證及測試項(xiàng)目均配備項(xiàng)目經(jīng)理，在為提供3Q認(rèn)證服務(wù)時及時匯報(bào)進(jìn)、嚴(yán)格控制質(zhì)量！云南微生物實(shí)驗(yàn)室驗(yàn)證咨詢公司</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，。IS P E 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；2. 對以下幾類物料存儲條件的管理：包裝物料，印<span style="display:none;"></span>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；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(bào)警流程，廢料處理等，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。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)需求云南微生物實(shí)驗(yàn)室驗(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、及國內(nèi)**的第三方檢測公司。 </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)，同時公司每年利潤的10%捐獻(xiàn)給中國貧困兒童，持久資助中國貧困兒童的教育。 </p></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/3012988.html</p></div></div></div></div></div><div id="gq3xebi" class="page-right twoColRt"><div id="nc2tf7k" class="box01 margin10 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