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src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431524511718/1685851.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="tmya72k" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431524511718/1685851.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="ibacir8" 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>湖南生化培養(yǎng)箱驗證咨詢公司,驗證咨詢公司</p><p><span>***更新：</span>2020-08-10 10:07:46</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="revct8p" 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="yx8qx93" class="page-proshow02"><p class="title">詳細說明</p><div id="octvckl" class="box"><p><p> 什么是SRA，怎么做（是否與RA合并） </p> <p> GMP驗證咨詢服務(wù)過程中系統(tǒng)風險評估（SRA）是通過QRM檢驗直接影響系統(tǒng)的產(chǎn)品質(zhì)量風險控制措施的應(yīng)用，執(zhí)行系統(tǒng)風險評估的項目團隊應(yīng)包含能理解工藝和相關(guān)CQAs的相關(guān)風險的主題技術(shù)**（SMEs）。（對于標準的現(xiàn)成的或簡單的目錄系統(tǒng),一些組織認為沒有必要的執(zhí)行系統(tǒng)風險評估；可使用簡單的協(xié)議或報告（例如，安裝和運行驗證)來提供安裝和操作滿足系統(tǒng)需求的書面證據(jù)）。 </p> <p> 系統(tǒng)風險評估完成后，應(yīng)檢查 URS 以確保 CAs/CDEs 已包括在內(nèi)；若未包括在內(nèi)，則應(yīng)修訂 URS，湖南生化培養(yǎng)箱驗證咨詢公司，湖南生化培養(yǎng)箱驗證咨詢公司，將其加入。過程控制元素應(yīng)該添加到 C&Q 范圍中。系統(tǒng)的驗收和放行涉及確認系統(tǒng)風險評估中確定的控制措施如下: </p> <p> 1.已經(jīng)證明設(shè)計控件(CAs/CDEs)按照指定的方式運行； </p> <p> 2.過程控制已經(jīng)就位，湖南生化培養(yǎng)箱驗證咨詢公司。 </p> <p> <br /> 旦霆科技作為國內(nèi)**大中型規(guī)模綜合性咨詢服務(wù)公司，專業(yè)提供計算機化系統(tǒng)驗證服務(wù)，值得信賴！湖南生化培養(yǎng)箱驗證咨詢公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖南生化培養(yǎng)箱驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431524511718/1685851.jpg"></div><p> 運行確認（OQ）一旦滿足IQ階段的每個協(xié)議，就執(zhí)行操作資格（OQ）以在制造商特定的操作范圍內(nèi)檢查設(shè)備的性能是否與用戶要求規(guī)范一致。在OQ階段，3Q驗證，測試計劃中的所有項目都將單獨測試并記錄其性能。這是技術(shù)驗收設(shè)備和設(shè)施的先決條件，因此只有在IQ成功后才能執(zhí)行。除初始安裝后的資格認證外，還需要在對設(shè)備進行任何重大維護工作或修改后，或作為常規(guī)質(zhì)量保證計劃的一部分進行重新認證。OQ的主要目的是識別和檢查可能影響終產(chǎn)品質(zhì)量的設(shè)備特征，例如：·顯示單元和信號LED·溫度控制和波動·過熱和低溫保護系統(tǒng)和報警·壓力/真空控制系統(tǒng)·CO2控制系統(tǒng)·濕度測量和控制系統(tǒng)·風扇和風扇速度控制器·伺服電機和風門襟翼控制器·讀卡器和訪問控制器·溫度分布符合DIN12880：2007-05。廣東超微量分光光度計驗證咨詢公司旦霆科技對驗證測試工程師進行培訓拓展及考核晉級，為向客戶提供更專業(yè)的CSV驗證檢測服務(wù)而不斷邁進。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖南生化培養(yǎng)箱驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431513144531/7614493.jpg"></div><p> 消毒劑消毒效果驗證 </p> <p> 旦霆科技為企業(yè)提供消毒劑消毒效果驗證GMP驗證咨詢，藥廠常見消毒劑有如下幾種：75%乙醇、0.1%新潔爾滅溶液、0.3%新潔爾滅溶液、0.1%醋酸洗必泰、0.5%醋酸洗必泰、40mg/L的二氧化氯、60mg/L的二氧化氯，消毒劑效果驗證一般分為實驗室考察部分和現(xiàn)場考察部分，實驗室對消毒劑的殺菌效力測定方法常有定量懸浮試驗法、載體浸泡定量試驗法、表面試驗法、工作液直接接種法等多種試驗方法；現(xiàn) 場考察試驗用以評估消毒劑對相應(yīng) 設(shè) 施的實際消毒 </p> <p> 效力，如潔凈區(qū)的墻面、天花板、門窗、機器設(shè)備、儀器、操作臺、地漏、推車、桌椅等表面以及操作人員雙手（手套）。此類試驗是通過監(jiān) 測清潔（消毒）前后的環(huán) 境微生物質(zhì) 量進行的。經(jīng) 歷一段時間后才能積累用以評估消毒和淸潔程序的數(shù) 據(jù) （建議至少 3 次試驗）通常在 ** 差條件 ( 如預(yù) 防性維修之后）檢驗環(huán) 境的污染狀況，因為此時環(huán) 境中的微生物種類和數(shù) 量有上升的潛在可能性， </p><p> 旦霆科技為企業(yè)提供制藥用水系統(tǒng)GMP驗證咨詢其中IQ內(nèi)容包括：文件確認（圖紙確認/技術(shù)文件確認/材質(zhì)證明類文件確認/施工記錄/報告確認）,系統(tǒng)安全確認, 系統(tǒng)安裝環(huán)境確認, 公用介質(zhì)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(nèi)容包括：系統(tǒng)啟動和關(guān)閉確認，登錄權(quán)限確認，HMI界面和基本功能確認，用戶權(quán)限確認，控制柜急停功能確認，電機轉(zhuǎn)向確認，罐體排空確認，核黃素覆蓋率確認，預(yù)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(chǎn)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(tǒng)消毒功能確認，純化水分配系統(tǒng)消毒功能確認，純化水關(guān)鍵控制點取樣確認，用戶權(quán)限確認，互鎖/安全確認，報警確認，斷電恢復確認，數(shù)據(jù)打印功能確認；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）驗證交付物包括VP，SC，SRA，IQ，OQ，PQ，RTM以及VSR文件。旦霆科技成員具備多年工作經(jīng)驗、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驗證服務(wù)！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="湖南生化培養(yǎng)箱驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431512939453/2814885.jpg"></div><p> 分析方法驗證怎么做？ </p> <p> 旦霆科技為企業(yè)提供分析方法驗證GMP驗證咨詢。分析方法驗證的目的是證明所采用的方法達到相應(yīng)的檢測要求，驗證的內(nèi)容主要包括準確度、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行哪些項目的驗證，應(yīng)根據(jù)實際情況而定，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，如藥典標準和部頒標準，*做系統(tǒng)適用性試驗即可。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，就需進行系統(tǒng)的方法驗證。 </p> <p> 2. 對于已在一實驗室驗證過但需在另一個實驗室使用的分析方法，可采用對照試驗法。即取同一批樣品，按此方法在兩實驗室分別進行檢驗，將結(jié)果進行比較 ( </p> <p> 如用 t 檢驗法計算 ) ，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；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 </p> <p> <br /> </p> <p> </p> <p> <br /> </p> <p> 旦霆科技配備專業(yè)的質(zhì)量部，進行驗證審核、報告審核等質(zhì)量監(jiān)管，專業(yè)提供CSV驗證及咨詢服務(wù)，值得信賴！福建新建廠房驗證咨詢公司</p><p style="text-indent:25px">旦霆科技擁有良好的驗證及檢測理念，為CSV驗證服務(wù)提供保障！湖南生化培養(yǎng)箱驗證咨詢公司</p><p> 儀器校正相關(guān)規(guī)定 </p> <p> <br /> </p> <p> 實驗室的儀器設(shè)備種類相當多，若我們依設(shè)備的校正屬性來做分類，可以區(qū)分成下列三類： </p> <p> <br /> </p> <p> 一、需定期校正者： </p> <p> <br /> </p> <p> 凡用于制劑量測等事宜，以做為產(chǎn)品放行或向主管機關(guān)送件用之依據(jù)者，都屬于這一類的儀器設(shè)備。 </p> <p> <br /> </p> <p> 這些設(shè)備必須制訂合理校正的計劃，訂立合理的校正周期，定期以標準品對這些儀器設(shè)備進行測試，并判斷所得到的響應(yīng)是否正常，加以記錄。 </p> <p> <br /> </p> <p> 而標準品的選定必須是可回溯的，在校正的動作完成之后，必須在這類儀器上貼上“校正標”，標上至少應(yīng)具備以下資訊：***一次校正日期、招待校正人員簽名、目前校正之有效期限等。這一類的儀器在實驗室中為數(shù)**多。 </p> <p> <br /> </p> <p> 例如：HPLC、UV/VIS、FTIR、AA、旋光度計、天平、熒光光譜儀、自動滴定儀、崩散度計、磨損度計及烘箱等。 </p> <p> <br /> </p> <p> 這些儀器必須按照既定的校正計劃嚴格執(zhí)行校正，若發(fā)現(xiàn)該儀器有偏離校正容許范圍時，校正者應(yīng)發(fā)出正式之通告，并循標準程序排除障礙。 </p> <p> <br /> 湖南生化培養(yǎng)箱驗證咨詢公司</p><p style="text-indent:25px">旦霆生物科技（上海）有限公司創(chuàng)立于2014-04-21，是一家服務(wù)型公司。公司業(yè)務(wù)分為[ "GMP驗證咨詢與服務(wù)", "計算機化系統(tǒng)驗證", "壓縮空氣檢測", "潔凈室檢測" ]等，目前不斷進行創(chuàng)新和服務(wù)改進，為客戶提供質(zhì)量的產(chǎn)品和服務(wù)。公司秉持誠信為本的經(jīng)營理念，在醫(yī)藥、保養(yǎng)深耕多年，以技術(shù)為先導，以自主產(chǎn)品為**，發(fā)揮人才優(yōu)勢，打造醫(yī)藥、保養(yǎng)質(zhì)量品牌。在社會各界的鼎力支持下，經(jīng)過公司所有人員的努力，公司自2014-04-21成立以來，年營業(yè)額達到700-1000萬元。</p></p><br /><p>文章來源地址: http://m.cdcfah.com/cp/868312.html</p></div></div></div></div></div><div id="ilso303" class="page-right twoColRt"><div id="8vhi7wk" class="box01 margin10 clearfix"><h3><a href="http://m.cdcfah.com/cp/">猜你喜歡</a></h3><div id="uypws4r" class="recomPic likePro"><a href="http://m.cdcfah.com/cp/814588.html"><div><img src="http://tyunfile.71360.com/UpLoadFile/2019/11/1/14/637082168864691056_lgpj_5374157.jpg" alt="福建ZF配件哪家強信息推薦自業(yè)物資供應(yīng)" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></div><p>福建ZF配件哪家強信息推薦自業(yè)物資供應(yīng)</p></a></div><div id="vjamdhy" class="recomPic likePro"><a href="http://m.cdcfah.com/cp/846569.html"><div><img 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