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class="page-proshow clearfix"><p class="current"> 當前位置:<a href="http://www.cdcfah.com/">首頁?<a href="http://www.cdcfah.com/cp/">產品供應</a>?<a href="http://www.cdcfah.com/cp/first-_yyby/">醫(yī)藥健康</a>?<a 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>?中國香港潔凈車間驗證咨詢公司創(chuàng)新服務旦霆生物科技供應</p><div id="8sqnel3" class="leftbox clearfix"><h1>中國香港潔凈車間驗證咨詢公司創(chuàng)新服務旦霆生物科技供應</h1><div id="g2ja8qm" class="proBig"><div id="y8mjgnl" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431491503906/5150702.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="buwt7pr" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431491503906/5150702.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="slszvh7" class="content"><p><span>需求數量：</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>產品關鍵詞：</span>中國香港潔凈車間驗證咨詢公司,驗證咨詢公司</p><p><span>***更新：</span>2020-12-20 00:16:40</p><p><span id="click" >瀏覽次數：0次</span></p><a rel="nofollow" class="button">聯系我們</a></div></div><div id="qo32ixe" 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="f88dh8x" class="page-proshow02"><p class="title">詳細說明</p><div id="2iz83xu" class="box"><p><p> 驗證參考的法規(guī)文獻有哪些？ </p> <p> <br /> </p> <p> GMP驗證咨詢服務參考的法規(guī)/指南文件如下： </p> <p> <br /> </p> <p> (NMPA) 2010年版GMP及附錄確認與驗證 </p> <p> <br /> </p> <p> (NMPA) 2003藥品生產驗證指南 </p> <p> <br /> </p> <p> (EU) 歐盟GMP附錄15:《確認與驗證》2015.10 </p> <p> <br /> </p> <p> (EMA)《制劑工藝驗證指南-監(jiān)管性遞交需提供的信息和數據》2014.08 </p> <p> <br /> </p> <p> (FDA) 聯邦法規(guī)第21篇第210 211部分，成品藥的現行生產質量管理規(guī)范 </p> <p> <br /> </p> <p> (FDA)《工藝驗證：一般原則與慣例》2011，中國香港潔凈車間驗證咨詢公司.01 </p> <p> <br /> </p> <p> (PIC/S)GMP指南，藥用產品良好生產實踐指南 </p> <p> <br /> </p> <p> (PIC/S) 驗證指南文件 </p> <p> <br /> </p> <p> (TGA)GMP，藥用產品良好生產實踐指南 </p> <p> <br /> </p> <p> (PDA)第60號技術報告：《工藝驗證-一個生命周期方式》2013.02 </p> <p> <br /> </p> <p> (ISPE)指南第5卷：調試與確認（2nd）2019.06 旦霆科技感恩新老客戶的多年信賴，中國香港潔凈車間驗證咨詢公司，我們將再接再厲，中國香港潔凈車間驗證咨詢公司，持續(xù)為新老客戶提供質量、專業(yè)的CSV驗證服務！中國香港潔凈車間驗證咨詢公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="中國香港潔凈車間驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431491503906/5150702.png"></div><p> 工藝驗證是什么，怎么做？ </p> <p> 旦霆科技為企業(yè)提供工藝驗證GMP驗證咨詢。工藝驗證應當證明一個生產工藝按照規(guī)定的工藝參數能夠持續(xù)生產出符合預定用途和注冊要求的產品。在工藝驗證之前應確定以下工作已完成: </p> <p> 1.所使用的設備或設施已完成安裝確認 (IQ) ，運行確認 (OQ) 和性能確認（PQ）； </p> <p> 2.產品的質量標準已確定； </p> <p> 3.分析方法驗證已完成； </p> <p> 工藝驗證一般要求生產至少連續(xù)3批，對于新產品的工藝驗證，由于產品產品從小試成功，中試放大，再到商業(yè)化生產中一些工藝參數還不能確定，因此推薦先進行至少1個批號的開發(fā)批工藝驗證，跟進此次數據調整一些工藝參數和設備操作，為正式工藝驗證提供可靠數據基礎，但開發(fā)批的產品必須檢驗全部符合質量標準，且偏差得到有效調查評估后才可關閉。根據開發(fā)批驗證的數據修改SOP，并起草工藝驗證方案。 </p> <p> <br /> 中國香港潔凈車間驗證咨詢公司旦霆科技為提升各項目質量水平，成立質量部門。為3Q認證等驗證及檢測服務保駕護航！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="中國香港潔凈車間驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431524472656/5236721.jpg"></div><p> 旦霆科技為企業(yè)提供冷鏈運輸系統GMP驗證咨詢。安裝確認報告以及運行確認方案已完成，冬季、夏季溫度曲線確認，模擬時間曲線（物流流線圖）確認，產品 ** 大 </p> <p> /**小裝載/季節(jié)測試，溫度比對測試以及按照風險評估結果的其他測試項目；性能測試包括以下內容：確認安裝確認和運行確認已經完成，性能確認方案得到批準，SOP狀態(tài) 應為已批準，測試儀器儀表校準確認，典型產品裝載按照運輸路線、運輸類型、運輸季節(jié)及運輸時間等運輸條件確認，溫度監(jiān)測和計算機系統數據備份的確認。 </p> <p> 冷鏈運輸倉儲物流系統中一般確定為直接影響系統的有：庫房、設施、設備、保溫包裝、運輸工具和監(jiān)控儀器等系統驗證，對于物流系統的風險評估，首先需要確定運輸的環(huán)境，分析運輸過程中可能對產品（藥品或包材）產生的危害，驗證應重點考慮環(huán)境溫度變化、冷藏藥品穩(wěn) 定性數據、運輸或配送的相關信息、包裝部件的設計等。冷鏈運輸車的安裝確認主要是冷藏車的確認，包括制冷系統的安裝，自動控制系統的安裝，以及設備狀態(tài)及關鍵儀表的校準狀態(tài)的確認；運行確認一般在實驗室內完成，這些測試應該能夠保證包裝和運輸方案能夠維持產品所處的內部環(huán)境。測試應該包括冷點和熱點的確認，震蕩測試，受壓測試等。 </p><p> 各項驗證與測試 </p> <p> <br /> </p> <p> 在各項驗證中，確認儀器的個別或整體性能，必須對儀器進行各項測試，測試是指系統中誤差的鑒定，當我們用已知(亦即可回溯)的標準品對儀器進行測試時，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行調整的動作，并將原來偏差的部分調回標準的規(guī)格，這個過程我們可稱之為標準化。 </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準品，就成為相當重要的課題。 </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準，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，對于詳細的驗證程序著墨不多，在驗證中，需根據現實情況做調整。 </p> <p> <br /> </p> <p> <br /> 旦霆科技作為國內**的綜合性驗證咨詢公司，專業(yè)解答各種CSV認證及偏差處理等相關問題，歡迎您的垂詢！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="中國香港潔凈車間驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431513359375/9658238.jpg"></div><p> 空調系統與潔凈室驗證內容 </p> <p> 旦霆科技為企業(yè)提供空調系統與潔凈廠房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內容包括：文件確認（圖紙確認/技術文件確認/材質證明類文件確認/施工記錄/報告確認）, </p> <p> 系統安全確認, 系統安裝環(huán)境確認, 公用介質連接確認, 儀器儀表校準確認, 潔凈區(qū)安裝確認, </p> <p> 空調系統部件安裝確認，PLC及HMI確認，標識確認以及I/O測試確認，OQ內容包括：系統啟動和關閉確認，登錄權限確認，HMI界面和基本功能確認，用戶權限確認，報警確認，斷電恢復確認，自動運行確認，風量及換氣次數確認測，壓差確認，高效過濾器及邊框完整性確認，溫度/相對濕度確，噪音確認測，照度確認，氣流流型確認，自凈時間確認，懸浮粒子確認，浮游菌確認，沉降菌確認；PQ內容包括：溫度/相對濕度確認，懸浮粒子確認，浮游菌確認，沉降菌確認測試以及表面微生物，動態(tài)執(zhí)行三次。旦霆科技不斷強化團隊管理、品牌價值及服務升級，以質量的理念為企業(yè)提供高水準的CSV驗證服務！云南負170度氣態(tài)液氮儲存罐驗證咨詢公司</p><p style="text-indent:25px">旦霆科技作為國內**大中型規(guī)模綜合性咨詢服務公司，專業(yè)提供計算機化系統驗證服務，值得信賴！中國香港潔凈車間驗證咨詢公司</p><p> 旦霆科技為企業(yè)提供制藥用水系統GMP驗證咨詢其中IQ內容包括：文件確認（圖紙確認/技術文件確認/材質證明類文件確認/施工記錄/報告確認）,系統安全確認, 系統安裝環(huán)境確認, 公用介質連接確認, 儀器儀表校準確認,機械部件安裝確認，HMI及PLC確認，標識確認，I/O測試確認；OQ內容包括：系統啟動和關閉確認，登錄權限確認，HMI界面和基本功能確認，用戶權限確認，控制柜急停功能確認，電機轉向確認，罐體排空確認，核黃素覆蓋率確認，預處理清洗、消毒功能確認，軟化器自動再生功能確認，反滲透自動沖洗功能確認，自動程序運行確認，純化水流速及產能確認，電加熱空氣呼吸器（保溫純化水箱）加熱功能確認，紫外滅菌器計時功能確認，反滲透系統消毒功能確認，純化水分配系統消毒功能確認，純化水關鍵控制點取樣確認，用戶權限確認，互鎖/安全確認，報警確認，斷電恢復確認，數據打印功能確認；PQ內容包括：第1階段（評價階段），第2階段（短期質量控制階段）驗證交付物包括VP，SC，SRA，IQ，OQ，PQ，RTM以及VSR文件。中國香港潔凈車間驗證咨詢公司</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、制藥設備等行業(yè)提供GXP合規(guī)咨詢、驗證服務以及培訓的綜合性咨詢公司； </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等機構的GMP認證檢查； </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**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為客戶提供服務，同時公司每年利潤的10%捐獻給中國貧困兒童，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/2473417.html</p></div></div></div></div></div><div id="1qryf7a" class="page-right twoColRt"><div id="vyu74ul" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="p2ofr3t" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/814588.html"><div><img 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