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class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431491337890/60026.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="fogfgnu" 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>河南液態(tài)加壓罐驗證咨詢公司,驗證咨詢公司</p><p><span>***更新：</span>2020-12-18 00:15:59</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="sq2hegn" 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="o87fxpm" class="page-proshow02"><p class="title">詳細說明</p><div id="zv7g8wl" class="box"><p><p> 旦霆科技為企業(yè)提供倉儲物流系統(tǒng)GMP驗證咨詢，。IS P E 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，河南液態(tài)加壓罐驗證咨詢公司.廠房管理：包括培訓，清潔，維護，蟲害控制以及安全；2. 對以下幾類物料存儲條件的管理：包裝物料，印<span style="display:none;"></span>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，接收和發(fā)貨）等；3.對溫度受控區(qū)域的控制：規(guī)范要求，產(chǎn)品數(shù)據(jù)，相應的清潔，維護，河南液態(tài)加壓罐驗證咨詢公司，校準，確認，監(jiān)控，報警流程，廢料處理等，4.運輸：運輸方法的制定和驗證，供應商審計，供應商性能確認/ 監(jiān) 測，貨物檢測 / 性能監(jiān)測等等。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，河南液態(tài)加壓罐驗證咨詢公司，如何對制藥企業(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)提出了相應的法規(guī)需求旦霆科技各類行業(yè)的驗證服務經(jīng)驗，專業(yè)為您提供CSV認證，值得信賴！河南液態(tài)加壓罐驗證咨詢公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河南液態(tài)加壓罐驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431491337890/60026.jpg"></div><p> 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> 河南液態(tài)加壓罐驗證咨詢公司CSV認證服務選旦霆科技，多年的驗證服務經(jīng)驗，成熟的驗證體系，品質(zhì)優(yōu)先，良心推薦。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河南液態(tài)加壓罐驗證咨詢公司,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. 反應罐系統(tǒng) </p> <p> 3. 超濾系統(tǒng) </p> <p> 離心機系統(tǒng) </p><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，旦霆科技專業(yè)提供3Q認證、驗證服務及第三方檢測，技術(shù)實力雄厚，值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河南液態(tài)加壓罐驗證咨詢公司,驗證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431490947265/1428486.jpg"></div><p> 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。旦霆科技不但擁有龐大的驗證及檢測團隊，同時配備幾百套驗證及檢測儀器，專業(yè)開展CSV驗證服務！河南液態(tài)加壓罐驗證咨詢公司</p><p style="text-indent:25px">旦霆科技擁有先進的驗證理念，成熟的驗證體系，為您提供專業(yè)、質(zhì)量的計算機化系統(tǒng)驗證服務。河南液態(tài)加壓罐驗證咨詢公司</p><p> 什么是用戶需求，用戶需求包含什么內(nèi)容？ </p> <p> GMP驗證咨詢服務中，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(shè)備及相關(guān)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(shù)、GxP、生物安全、操作安全等相關(guān)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(guān)和不相關(guān)，GMP相關(guān)需求構(gòu)成確認和驗證的基礎(chǔ)。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(shè)計規(guī)范和詳細設(shè)計規(guī)范中。河南液態(tài)加壓罐驗證咨詢公司</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(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，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/2445259.html</p></div></div></div></div></div><div id="gvsur7i" class="page-right twoColRt"><div id="dnkmjbn" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="ixubyfc" class="recomPic likePro"><a 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