中國香港保溫箱3Q認證創(chuàng)新服務旦霆生物科技供應-b2b網(wǎng)站_b2b電子商務平臺【買產(chǎn)品】-上?？谄蚴称酚邢薰?/title><meta name="description" content="驗證參考的法規(guī)文獻有哪些？3Q認證參考的法規(guī)/指南文件如下：(NMPA)2010年版GMP及附錄確認與驗證(NMPA)2003藥品生產(chǎn)驗證指南(EU)歐盟GMP附錄15:《確認與驗證》2015.10(EMA)《制劑工藝驗證指南-監(jiān)管性遞交需"><meta name="keywords" content="中國香港保溫箱3Q認證,3Q認證"><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" content="no-transform" /> <meta 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clearfix"><h1>中國香港保溫箱3Q認證創(chuàng)新服務旦霆生物科技供應</h1><div id="7yikmjw" class="proBig"><div id="pjldfct" class="bigimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309147939453/5125649.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="eol778x" class="smallimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309147939453/5125649.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="aurtlcz" 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)品關鍵詞：</span>中國香港保溫箱3Q認證,3Q認證</p><p><span>***更新：</span>2021-01-21 01:04:55</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="p237li3" 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="pqxzr2s" class="page-proshow02"><p class="title">詳細說明</p><div id="ga7h8jf" class="box"><p><p> 驗證參考的法規(guī)文獻有哪些？ </p> <p> <p> 3Q認證參考的法規(guī)/指南文件如下： </p> <p> (NMPA) 2010年版GMP及附錄確認與驗證 </p> <p> (NMPA) 2003藥品生產(chǎn)驗證指南 </p> <p> (EU) 歐盟GMP附錄15:《確認與驗證》2015.10 </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(shù)據(jù)》2014.08 </p> <p> (FDA) 聯(lián)邦法規(guī)第21篇第210 211部分，成品藥的現(xiàn)行生產(chǎn)質量管理規(guī)范 </p> <p> (FDA)《工藝驗證：一般原則與慣例》2011.01 </p> <p> (PIC/S)GMP指南，中國香港保溫箱3Q認證，藥用產(chǎn)品良好生產(chǎn)實踐指南 </p> <p> (PIC/S) 驗證指南文件 </p> <p> (TGA)GMP，中國香港保溫箱3Q認證，中國香港保溫箱3Q認證，藥用產(chǎn)品良好生產(chǎn)實踐指南 </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> (ISPE)指南第5卷：調試與確認（2nd）2019.06 </p> 旦霆科技不斷強化團隊管理、品牌價值及服務升級，以質量的理念良好的信譽為企業(yè)提供高水準的3Q認證服務！中國香港保溫箱3Q認證</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="中國香港保溫箱3Q認證,3Q認證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309147939453/5125649.jpg"></div><p> 二氧化碳培養(yǎng)箱3Q認證內(nèi)容包括如下： </p> <p> PQ內(nèi)容：根據(jù)甲方SOP運行、3次。 </p> <p> OQ內(nèi)容：預確認(確認安裝確認是否完成,安裝確認中出現(xiàn)的偏差是否已關閉，設備操作SOP是否已審批完成)，啟動/關閉確認，按鍵功能確認，參數(shù)設置功能確認，轉速確認，計時器比對確認，溫度控制功能確認，升/降速時間確認，噪聲確認，報警/安全功能確認。 </p> <p> IQ內(nèi)容: 技術類文件確認, 設備儀表校準確認, 安裝位置和安裝環(huán)境確認, 部件安裝確認, 公用系統(tǒng)連接確認和標識確認。 </p> <p> <br /> </p> <p> <br /> 中國香港保溫箱3Q認證旦霆科技配備數(shù)十人的驗證及檢測團隊，承接國內(nèi)各類相關企業(yè)的3Q認證、第三方驗證或檢測及咨詢服務。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="中國香港保溫箱3Q認證,3Q認證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309137382812/4789865.png"></div><p> 前驗證怎么做？ </p> <p> <br /> </p> <p> 新品、新型設備及其生產(chǎn)工藝的引入應采用前驗證的方式。3Q認證中前驗證的目標考察并確認工藝的重現(xiàn)性及可靠性，因此前驗證前必須有比較充分和完整的產(chǎn)品和工藝的開發(fā)資料，實施前以下工作應已完成： </p> <p> 1. 配方的設計、篩選及推薦已完成； </p> <p> 2. 中試性生產(chǎn)已完成，關鍵的工藝及工藝變量已經(jīng)確定，相應參數(shù)的控制限已經(jīng)摸清； </p> <p> 3. 已有生產(chǎn)工藝方面的詳細技術資料，包括有文件記載的產(chǎn)品穩(wěn)定性考察資料； </p> <p> 4. 即使是比較簡單的工藝，也已完成了一個批號的試生產(chǎn)。 </p> <p> 5. 中試放大至試生產(chǎn)中應無明顯的“數(shù)據(jù)漂移”或“工藝過程的因果關系發(fā)生畸變”現(xiàn)象。 </p> <p> 前驗證實施前，生產(chǎn)和管理人員都已進行了必要的培訓，***的了解所需驗證的工藝及其要求。 </p> <p> <br /> </p><p style="text-indent:25px">以證明某項工藝達到預計要求的活動。以水系統(tǒng)驗證為例，人們很難制造一個原水污染變化的環(huán)境條件來考察水系統(tǒng)的處理能力并根據(jù)原水污染程度來確定系統(tǒng)運行參數(shù)的調控范圍，這種條件下，同步驗證成了合理的選擇。這種情況下，工藝驗證的實際概念是特殊監(jiān)控條件下的試生產(chǎn)，而在試生產(chǎn)性的工藝驗證過程中，可以同時獲得兩方面的結果：一是合格的產(chǎn)品，二是驗證的結果，即“工藝重現(xiàn)性及可靠性”的證據(jù)。由于同步驗證與生產(chǎn)同時進行，因此該驗證方式可能帶來產(chǎn)品質量方面的風險，因此，企業(yè)應根據(jù)自己的實際情況作出適當?shù)倪x擇，且在制定驗證方案并實施驗證時，特別注意這種方式的先決條件，分析主客觀的情況并預計驗證結果對保證質量可靠性的風險程度。3Q認證中，同步驗證是在工藝常規(guī)運行的同時進行的驗證，即從工藝實際運行過程中獲得的數(shù)據(jù)來確立文件的依據(jù)旦霆科技成立至今為超過800多家企業(yè)提供GMP咨詢、3Q認證等服務，口碑良好，性價比高！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="中國香港保溫箱3Q認證,3Q認證" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175309138359375/982422.jpg"></div><p> 什么是性能確認，怎么做？ </p> <p> <br /> </p> <p> 3Q認證過程中性能確認應在安裝確認和運行確認成功完成之后執(zhí)行。性能確認可通過文件證明當設備、設施等與其他系統(tǒng)完成連接后能夠有效地可重復的發(fā)揮作用，即通過測試設施、設備等的產(chǎn)出物來證明它們的正確性。就工藝設備而言，性能確認實際上是通過實際負載生產(chǎn)的方法，考察其運行的可靠性、關鍵工藝參數(shù)的穩(wěn)定性和產(chǎn)出的產(chǎn)品的質量均一性、重現(xiàn)性的一系列活動進行。 </p> <p> 性能確認前應考慮以下內(nèi)容： </p> <p> ① 確認安裝確認/運行確認報告已完成并審批，沒有未關閉的偏差或存在的偏差不影響性能確認； </p> <p> ② 用于完成性能確認測試的分析方法已經(jīng)計對其預期用途經(jīng)過了充分的驗證/確認； </p> <p> ③ 用于性能確認測試的所有實驗室設備和儀器均已經(jīng)過了充分的確認或校準。 </p> <p> 性能測試應包含以下內(nèi)容： </p> <p> ?性能測試經(jīng)常包括一些合理的“挑戰(zhàn)”檢測，確保系統(tǒng)“挑戰(zhàn)”后能繼續(xù)滿足工藝要求； </p> <p> ?性能測試將主要涉及工藝相關的關鍵工藝參數(shù)，如滅菌/除熱原周期確認、清潔挑戰(zhàn)測試、微生物挑戰(zhàn)測試、滿載熱穿透測試等內(nèi)容。關鍵工藝參數(shù)設定后，其實際生產(chǎn)運行時應在規(guī)定的范圍內(nèi)波動； </p> <p> ?輸出的質量均一行、重現(xiàn)性：對輸出進行取樣檢測，各項質量指標均在預定標準之內(nèi)。 </p> <p> <br /> 旦霆科技擁有幾百套進口及國產(chǎn)儀器，提供專業(yè)3Q認證等驗證及檢測服務，在承接眾多業(yè)務下保證設備充足！中國香港保溫箱3Q認證</p><p style="text-indent:25px">旦霆科技布局細胞行業(yè)，目前為20余家相關行業(yè)的公司提供3Q認證及咨詢等服務。中國香港保溫箱3Q認證</p><p> 什么是用戶需求，用戶需求包含什么內(nèi)容？ </p> <p> 3Q認證中，用戶需求（URS）是指用戶為滿足GMP法規(guī)、工藝用途等提出的對設備及相關系統(tǒng)的要求，因此，用戶需求編制應依據(jù)工藝規(guī)程和法規(guī)要求，其內(nèi)容包括技術、GxP、生物安全、操作安全等相關方面。用戶應對所有用戶需求進行編號以便追蹤，并將其分類為與GMP相關和不相關，GMP相關需求構成確認和驗證的基礎。用戶需求編制時應注意，文件應描述系統(tǒng)“應該做到的”，而不是“如何做”，用戶應在與系統(tǒng)供應商溝通后確定“如何做”，并將其記錄在功能設計規(guī)范和詳細設計規(guī)范中。中國香港保溫箱3Q認證</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(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/2934665.html</p></div></div></div></div></div><div id="xmegiur" class="page-right twoColRt"><div id="wlikmo7" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="on2xebn" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/814588.html"><div><img 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