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onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="udasrta" 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>江西驗證咨詢公司,驗證咨詢公司</p><p><span>***更新：</span>2021-01-27 06:04:40</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="imjlnuw" 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="t7oaspr" class="page-proshow02"><p class="title">詳細說明</p><div id="jyasurd" class="box"><p><p> 倉儲物流系統(tǒng)簡介 </p> <p> 旦霆科技為企業(yè)提供倉儲物流系統(tǒng)GMP驗證咨詢，制藥企業(yè) 的產(chǎn) 品通過生產(chǎn) 、存儲、運輸及交付，**終才能到達患者的手中，為保證患者的安全，如何對制<span style="display:none;"></span>藥企業(yè) 的倉儲物流系統(tǒng) 進行驗證成為關(guān) 注的重點問題。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。ISPE<span style="display:none;"></span>冷鏈管理中對藥品的冷鏈則提出了具體的質(zhì)量計劃，從倉儲運輸做出了具體規(guī)劃： </p> <p> 1.廠房管理：包括培訓(xùn)，清潔，維護，蟲害控制以及安全； </p> <p> 2. 對以下幾類物料存儲條件的管理：包裝物料，印刷物料，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； </p> <p> 3，江西驗證咨詢公司.對溫度受控區(qū)域的控制：規(guī)范要求，產(chǎn)品數(shù)據(jù)，江西驗證咨詢公司，相應(yīng)的清潔，維護，校準，確認，監(jiān)控，報警流程，廢料處理等， </p> <p> 4.運輸：運輸方法的制定和驗證，江西驗證咨詢公司，供應(yīng) 商審計，供應(yīng) 商性能確認 / 監(jiān) 測，貨物檢測 / 性能監(jiān) 測等等。旦霆科技擁有專業(yè)的驗證團隊，專業(yè)的驗證設(shè)備，為您提供專業(yè)、質(zhì)量的計算機化系統(tǒng)驗證服務(wù)！江西驗證咨詢公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江西驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431524472656/9507670.png"></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。江西驗證咨詢公司旦霆科技是國內(nèi)無數(shù)不多的為制藥及醫(yī)療器械等相關(guān)行業(yè)提供3Q認證服務(wù)的專業(yè)第三方咨詢公司。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江西驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431491337890/60026.jpg"></div><p> 旦霆科技為企業(yè)提供生物制品工藝驗證GMP驗證咨詢，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.離心機系統(tǒng) </p> <p> 細胞庫制備及保存設(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，細胞計數(shù)儀，流式細胞儀，程序降溫儀等； </p> <p> 細胞復(fù)蘇過程：水浴鍋，生物安全柜，恒溫培養(yǎng)箱，搖床，CO2培養(yǎng)箱等； </p> <p> 細胞培養(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，中轉(zhuǎn)罐等； </p> <p> 純化和精制過程：離心機，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. 超濾系統(tǒng) </p> <p> 離心機系統(tǒng) </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 /> 旦霆科技各類行業(yè)的驗證服務(wù)經(jīng)驗，專業(yè)為您提供CSV認證，值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江西驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431491503906/5150702.png"></div><p> 再驗證怎么做? </p> <p> GMP驗證咨詢服務(wù)中，再驗證是指一項生產(chǎn)工藝、一個系統(tǒng)或設(shè)備、或一種原材料經(jīng)過驗證，并在使用一個階段后，旨在證實其“驗證狀態(tài)”沒有發(fā)生漂移而進行的驗證。再驗證通常由下述三個原因引起： </p> <p> 1. 藥監(jiān)部門或法規(guī)要求的強制性再驗證：如無菌操作的培養(yǎng)基灌裝試驗，計量器具的強制檢定 </p> <p> 2. 發(fā)生變更時的“改變”性再驗證：如包裝形式的改變，工藝參數(shù)或工藝路線的變更，關(guān)鍵設(shè)備變更，生產(chǎn)***變更，常規(guī)檢測表明系統(tǒng)存在著影響質(zhì)量的變遷情況； </p> <p> 3. 每隔一段時間進行的“定期”再驗證：如滅菌設(shè)備、關(guān)鍵潔凈區(qū)的空調(diào)凈化系統(tǒng)等。 </p> <p> 在下列情況下需進行再驗證： </p> <p> (1)關(guān)鍵設(shè)備大修或更換及程控設(shè)備在預(yù)定生產(chǎn)一定周期后。 </p> <p> (2)批量數(shù)量級的變更。 </p> <p> (3)趨勢分析中發(fā)現(xiàn)有系統(tǒng)性偏差。 </p> <p> (4)當影響產(chǎn)品質(zhì)量的主要因素，如工藝、質(zhì)量控制方法、主要原輔料、主要生產(chǎn)設(shè)備或主要生產(chǎn)介質(zhì)發(fā)生改變時。 </p> <p> 生產(chǎn)企業(yè)應(yīng)根據(jù)自身產(chǎn)品及工藝的特點制定再驗證的周期，一般不宜超過2年。即使在設(shè)備及規(guī)程沒有任何變更的情況下，也要求定期進行再驗證。如產(chǎn)品的滅菌設(shè)備，在正常的情況下須每年作1次再驗證，又如培養(yǎng)基模擬分裝試驗每年至少2次。 </p> <p> <br /> </p> <p> </p> <p> <br /> </p> <p> 旦霆科技專業(yè)提供驗證咨詢、CSV認證及技術(shù)支持，**解答專業(yè)技術(shù)問題，歡迎您的垂詢！江西驗證咨詢公司</p><p style="text-indent:25px">旦霆科技在提供高質(zhì)量服務(wù)的同時為眾多客戶解決項目偏差、驗證偏差等問題。以保證3Q認證服務(wù)的順利進行。江西驗證咨詢公司</p><p> 冷鏈運輸系統(tǒng)驗證 </p> <p> 旦霆科技為企業(yè)提供冷鏈運輸系統(tǒng)GMP驗證咨詢冷鏈運輸倉儲物流系統(tǒng)中一般確定為直接影響系統(tǒng)的有：庫房、設(shè)施、設(shè)備、保溫包裝、運輸工具和監(jiān)控儀器等系統(tǒng)驗證，對于物流系統(tǒng)的風險評估，首先需要確定運輸?shù)沫h(huán)境，分析運輸過程中可能對產(chǎn)品<span style="display:none;"></span>（藥品或包材）產(chǎn)生的危害，驗證應(yīng)重點考慮環(huán)境溫度變化、冷藏藥品穩(wěn) 定性數(shù)據(jù)、運輸或配送的相關(guān)信息、包裝部件的設(shè)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(tǒng)的安裝，自動控制系統(tǒng)的安裝，以及設(shè)備狀態(tài)及關(guān)鍵儀表的校準狀態(tài)的確認；運行確認一般在實驗室內(nèi)完成，這些測試應(yīng)該能夠保證包裝和運輸方案能夠維持產(chǎn)品所處的內(nèi)部環(huán)境。測試應(yīng)該包括冷點和熱點的確認，震蕩測試，受壓測試等。一般包括以下測試項：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，產(chǎn)品比較大/**小裝載/季節(jié)測試，溫度比對測試以及按照風險評估結(jié)果的其他測試項目；性能測試包括以下內(nèi)容：確認安裝確認和運行確認已經(jīng)完成，性能確認方案得到批準，SOP狀態(tài)應(yīng)為已批準，測試儀器儀表校準確認，典型產(chǎn)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(tǒng)數(shù)據(jù)備份的確認。江西驗證咨詢公司</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/3031063.html</p></div></div></div></div></div><div id="jtv7i3f" class="page-right twoColRt"><div id="uzr7j9y" 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