重慶無塵車間驗證咨詢公司誠信為本旦霆生物科技供應(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="生物學(xué)測定方法驗證旦霆科技為企業(yè)提供生物制品生物學(xué)分析方法GMP驗證咨詢，生物學(xué)測定方法依賴于生物基質(zhì)（如動物、活細(xì)胞或目標(biāo)受體的功能復(fù)合體等）通常比化學(xué)實驗變異性更大，主要的是生物活性（或效價、效力）測定。生物活性測定包括以下方法：1.動"><meta name="keywords" content="重慶無塵車間驗證咨詢公司,驗證咨詢公司"><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 name="baidu-site-verification" content="OBVzrC9aaQ" /> <meta http-equiv="Cache-Control" 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href="http://www.cdcfah.com/cp/second-yyby_swzp/">生物制品</a>?<a href="http://www.cdcfah.com/cp/third-swzp_qtswzp/">其他生物制品</a>?重慶無塵車間驗證咨詢公司誠信為本旦霆生物科技供應(yīng)</p><div id="8exgayc" class="leftbox clearfix"><h1>重慶無塵車間驗證咨詢公司誠信為本旦霆生物科技供應(yīng)</h1><div id="wdx2f4x" class="proBig"><div id="6t8ai7x" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431512939453/2814885.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="1i1lafz" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431512939453/2814885.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="zqzqjxx" 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>重慶無塵車間驗證咨詢公司,驗證咨詢公司</p><p><span>***更新：</span>2021-01-17 01:06:22</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="r87qca9" 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: </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="87fxmgj" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="6pn6iuo" class="box"><p><p> 生物學(xué)測定方法驗證 </p> <p> 旦霆科技為企業(yè)提供生物制品生物學(xué)分析方法GMP驗證咨詢，生物學(xué)測定方法依賴于生物基質(zhì)（如動物、活細(xì)胞或目標(biāo)受體的功能復(fù)合體等）通常比化學(xué)實驗變異性更大，主要的是生物活性（或效價、效力）測定。生物活性測定包括以下方法：1.動物試驗方法，2.在細(xì)胞水平上測定產(chǎn)品的生化和生理效應(yīng)的細(xì)胞培養(yǎng)檢測方法；3，重慶無塵車間驗證咨詢公司.利用酶反應(yīng)速率或免疫相互作用誘導(dǎo)的生物反應(yīng)等方法測定生物活性的生化檢測方法。依照方法來源不同，重慶無塵車間驗證咨詢公司，驗證的要求有所不同，標(biāo)準(zhǔn)方法）通常認(rèn)為在被確定為標(biāo)準(zhǔn)方法前巳經(jīng)過驗證，使用者在采用此類方法前只需證明實際使用條件下方法的適用性，對于非標(biāo)準(zhǔn)的方法通常需要經(jīng)過嚴(yán)格驗證。一般情況下，需驗證的分析項有：鑒別試驗、純度和雜質(zhì)檢査，重慶無塵車間驗證咨詢公司、原液或制劑中有效成分的含量測定及生物活性測定。旦霆科技將不斷完善，繼續(xù)以高質(zhì)量服務(wù)為客戶提供CSV驗證、技術(shù)支持及咨詢服務(wù)!重慶無塵車間驗證咨詢公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="重慶無塵車間驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431512939453/2814885.jpg"></div><p> 各項驗證與測試 </p> <p> <br /> </p> <p> 在各項驗證中，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證的項目及其標(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)的驗證程序著墨不多，在驗證中，需根據(jù)現(xiàn)實情況做調(diào)整。 </p> <p> <br /> </p> <p> <br /> 湖北實驗室驗證咨詢公司著眼質(zhì)量，靜思細(xì)量，旦霆科技為您提供專業(yè)的計算機化系統(tǒng)驗證服務(wù)，為您的合規(guī)之路保駕護(hù)航！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="重慶無塵車間驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431513242187/8526534.jpg"></div><p> 清潔驗證方案制定應(yīng)重點考慮以下內(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> 取樣與檢驗方法學(xué) </p> <p> 旦霆科技為企業(yè)提供清潔驗證方案GMP驗證咨詢。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。 </p><p> <br /> </p> <p> 風(fēng)險評估是一種用于評估并描述系統(tǒng)、設(shè)備或工藝的關(guān)鍵方面，以構(gòu)成編寫驗證方案的基礎(chǔ)的方法。在定義關(guān)鍵設(shè)計控制(CAs/CDEs)后，采用失效模式影響分析（Failure </p> <p> mode effects analysis, FMEA)或其他風(fēng)險評估工具來找出可能失效的影響。風(fēng)險評估結(jié)果以表格形式提供，每一行分別對應(yīng)一個需求或功能可能失效的風(fēng)險，每個風(fēng)險具有對應(yīng)編號。在表格中應(yīng)結(jié)合URS要求，以及設(shè)計確認(rèn)結(jié)果列出關(guān)鍵設(shè)計控制(CAs/CDEs)所有失效模式，并分析其失效的可能性，危害嚴(yán)重性以及失效的可檢測性，將失效模式分為高中低三級，并制定相應(yīng)的風(fēng)險降低策略。風(fēng)險降低策略可包含驗證策略的提出，制作針對系統(tǒng)的檢查表，制定相應(yīng)的SOP（如設(shè)備/儀器操作，人員管理，對關(guān)鍵功能模塊進(jìn)行定期維護(hù)，定期再驗證等）。GMP驗證咨詢服務(wù)過程中風(fēng)險評估是為了簡化驗證和減少不必要的確認(rèn)活動，應(yīng)通過風(fēng)險評估的方法確定待確認(rèn)的設(shè)備或系統(tǒng)以及每個系統(tǒng)所需要的驗證范圍和程度。旦霆科技擁有幾百套進(jìn)口及國產(chǎn)儀器，提供專業(yè)csv驗證及檢測服務(wù)，在承接眾多業(yè)務(wù)下保證設(shè)備充足！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="重慶無塵車間驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431490947265/1428486.jpg"></div><p> 制藥用水系統(tǒng)驗證內(nèi)容 </p> <p> 旦霆科技為企業(yè)提供制藥用水系統(tǒng)GMP驗證咨詢，驗證交付物包括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)各過程控制點和分配系統(tǒng)各取樣點進(jìn)行取樣檢測 </p> <p> <br /> 旦霆科技團(tuán)隊成員掌握國內(nèi)為GMP、國標(biāo)、ISO等相關(guān)法規(guī)，可為相關(guān)企業(yè)開展CSV認(rèn)證等服務(wù)。重慶潔凈室綜合性能檢測驗證咨詢公司</p><p style="text-indent:25px">旦霆科技可與客戶開展遠(yuǎn)程技術(shù)交流，解決難題為雙方良好合作打下扎實基礎(chǔ)，提供csv驗證等技術(shù)服務(wù)。重慶無塵車間驗證咨詢公司</p><p> 什么是需求追溯矩陣，怎么做？ </p> <p> ISPE </p> <p> GAMP5《良好自動化生產(chǎn)實踐指南-遵從GxP計算機化系統(tǒng)監(jiān)管的風(fēng)險管理方法》提到：在系統(tǒng)生命周期的早期就應(yīng)該識別并糾正系統(tǒng)缺點，設(shè)計審査和可追溯性有助于保證系統(tǒng)符合預(yù)定用途，并且可以通過在早期識別缺點并解決問題來降低總體項目成本?！盙MP驗證咨詢服務(wù)過程中，需求追溯性矩陣（Requirements </p> <p> traceability matrix, RTM)可與標(biāo)準(zhǔn)、要點和成果進(jìn)行比較，對特定問題點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)計需求經(jīng)過了驗證，并可以追溯到表明需求得到滿足的測試或驗證活動； </p> <p> 2.使得風(fēng)險管理和設(shè)計審査流程更有效率； </p> <p> 判斷所提交的變更需求會產(chǎn)生什么樣的影響； </p> <p> 3.有助于對所提交的變更進(jìn)行風(fēng)險評估； </p> <p> 4.確認(rèn)對變更進(jìn)行測試的范圍； </p> <p> 5.可在檢査和審査時快速準(zhǔn)確地反應(yīng)。重慶無塵車間驗證咨詢公司</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: 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