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id="hurypqc" class="proBig"><div id="b23yzbi" class="bigimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312263710937/8911479.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="wlsjqrx" class="smallimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312263710937/8911479.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="hwip38v" 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>貴州生化分析儀驗證GMP咨詢,GMP咨詢</p><p><span>***更新：</span>2021-01-26 00:14:41</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="7q4yfws" 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(jī): </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(dāng)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="sryvjug" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="zrtkgxo" class="box"><p><p> 驗證參考的法規(guī)文獻(xiàn)有哪些？ </p> <p> <p> GMP咨詢參考的法規(guī)/指南文件如下： </p> <p> (NMPA) 2010年版GMP及附錄確認(rèn)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(rèn)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，貴州生化分析儀驗證GMP咨詢.08 </p> <p> (FDA) 聯(lián)邦法規(guī)第21篇第210 211部分，貴州生化分析儀驗證GMP咨詢，成品藥的現(xiàn)行生產(chǎn)質(zhì)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，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，貴州生化分析儀驗證GMP咨詢，藥用產(chǎn)品良好生產(chǎn)實踐指南 </p> <p> (PDA)第60號技術(shù)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(diào)試與確認(rèn)（2nd）2019.06 </p> 旦霆科技專業(yè)提供驗證咨詢、GMP咨詢及技術(shù)支持，**解答專業(yè)技術(shù)問題，歡迎您的垂詢！貴州生化分析儀驗證GMP咨詢</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="貴州生化分析儀驗證GMP咨詢,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312263710937/8911479.jpg"></div><p> 冷鏈運(yùn)輸系統(tǒng)驗證 </p> <p> 旦霆科技為企業(yè)提供冷鏈運(yùn)輸系統(tǒng)GMP咨詢冷鏈運(yùn)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(yùn)輸工具和監(jiān)控儀器等系統(tǒng)驗證，對于物流系統(tǒng)的風(fēng)險評估，首先需要確定運(yùn) 輸的環(huán)境，分析運(yùn) 輸過程中可能對產(chǎn) 品（藥品或包材）產(chǎn)生的危害，驗證應(yīng)重點(diǎn)考慮環(huán)境溫度變化、冷藏藥品穩(wěn) 定性數(shù)據(jù)、運(yùn) 輸或配送的相關(guān)信息、包裝部件的設(shè)計等。冷鏈運(yùn)輸車的安裝確認(rèn)主要是冷藏車的確認(rèn)，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(zhǔn)狀態(tài)的確認(rèn)；運(yùn)行確認(rèn)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(yùn)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(diǎn)和熱點(diǎn)的確認(rèn)，震蕩測試，受壓測試等。一般包括以下測試項：安裝確認(rèn) 報告以及運(yùn)行確認(rèn)方案已完成，冬季、夏季溫度曲線確認(rèn)，模擬時間曲線（物流流線圖）確認(rèn)，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(fēng)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(rèn)安裝確認(rèn)和運(yùn)行確認(rèn)已經(jīng)完成，性能確認(rèn)方案得到批準(zhǔn)，測試儀器儀表校準(zhǔn) 確認(rèn)，典型產(chǎn)品裝載按照運(yùn) 輸路線運(yùn)輸類型、運(yùn)輸季節(jié)及運(yùn)輸時間等運(yùn)輸條件確認(rèn)，溫度監(jiān)測和計算機(jī)系統(tǒng)數(shù)據(jù)備份的確認(rèn)。貴州生化分析儀驗證GMP咨詢旦霆科技成員具備10年以上工作經(jīng)驗、良好的GMP理念、精通國內(nèi)外相關(guān)法規(guī)，可專業(yè)開展GMP咨詢服務(wù)！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="貴州生化分析儀驗證GMP咨詢,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312263828125/6888947.jpg"></div><p> 什么是SRA，怎么做（是否與RA合并） </p> <p> <br /> </p> <p> GMP咨詢過程中系統(tǒng)風(fēng)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(fēng)險控制措施的應(yīng)用，執(zhí)行系統(tǒng)風(fēng)險評估的項目團(tuán)隊?wèi)?yīng)包含能理解工藝和相關(guān)CQAs的相關(guān)風(fēng)險的主題技術(shù)**（SMEs）。（對于標(biāo)準(zhǔn)的現(xiàn)成的或簡單的目錄系統(tǒng),一些組織認(rèn)為沒有必要的執(zhí)行系統(tǒng)風(fēng)險評估；可使用簡單的協(xié)議或報告（例如，安裝和運(yùn)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(fēng)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，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(rèn)系統(tǒng)風(fēng)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(yùn)行； </p> <p> 2.過程控制已經(jīng)就位。 </p> <p> <br /> </p><p> 什么是用戶需求，用戶需求包含什么內(nèi)容？ </p> <p> GMP咨詢中，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(yīng)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(yīng)對所有用戶需求進(jìn)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(rèn)和驗證的基礎(chǔ)。用戶需求編制時應(yīng)注意，文件應(yīng)描述系統(tǒng)“應(yīng)該做到的”，而不是“如何做”，用戶應(yīng)在與系統(tǒng)供應(yīng)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(xì)設(shè)計規(guī)范中。旦霆科技專業(yè)為國內(nèi)制藥行業(yè)提供GMP咨詢服務(wù)、第三方測試執(zhí)行以及技術(shù)支持。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="貴州生化分析儀驗證GMP咨詢,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175311838671875/7440718.jpg"></div><p> 什么是風(fēng)險評估，怎么做？ </p> <p> GMP咨詢過程中風(fēng)險評估是為了簡化驗證和減少不必要的確認(rèn)活動，應(yīng)通過風(fēng)險評估的方法確定待確認(rèn)的設(shè)備或系統(tǒng)以及每個系統(tǒng)所需要的驗證范圍和程度。風(fēng)險評估是一種用于評估并描述系統(tǒng)、設(shè)備或工藝的關(guān)鍵方面，以構(gòu)成編寫驗證方案的基礎(chǔ)的方法。在定義關(guān)鍵設(shè)計控制(CAs/CDEs)后，采用失效模式影響分析（Failure mode effects analysis, FMEA)或其他風(fēng)險評估工具來找出可能失效的影響。風(fēng)險評估結(jié)果以表格形式提供，每一行分別對應(yīng)一個需求或功能可能失效的風(fēng)險，每個風(fēng)險具有對應(yīng)編號。在表格中應(yīng)結(jié)合URS要求，以及設(shè)計確認(rèn)結(jié)果列出關(guān)鍵設(shè)計控制(CAs/CDEs)所有失效模式，并分析其失效的可能性，危害嚴(yán)重性以及失效的可檢測性，將失效模式分為高中低三級，并制定相應(yīng)的風(fēng)險降低策略。風(fēng)險降低策略可包含驗證策略的提出，制作針對系統(tǒng)的檢查表，制定相應(yīng)的SOP（如設(shè)備/儀器操作，人員管理，對關(guān)鍵功能模塊進(jìn)行定期維護(hù)，定期再驗證等）。旦霆科技作為國內(nèi)為數(shù)不多的中大規(guī)模驗證公司，專業(yè)提供GMP咨詢服務(wù)，擁有幾十人的驗證團(tuán)隊，值得信賴！貴州生化分析儀驗證GMP咨詢</p><p style="text-indent:25px">旦霆科技不斷強(qiáng)化團(tuán)隊管理、服務(wù)升級，以質(zhì)量的理念良好信譽(yù)為企業(yè)提供高水準(zhǔn)的GMP咨詢服務(wù)！貴州生化分析儀驗證GMP咨詢</p><p> 工藝驗證一般要求生產(chǎn)至少連續(xù)3批，對于新產(chǎn)品的工藝驗證，由于產(chǎn)品產(chǎn)品從小試成功，中試放大，再到商業(yè)化生產(chǎn)中一些工藝參數(shù)還不能確定，因此推薦先進(jìn)行至少1個批號的開發(fā)批工藝驗證，跟進(jìn)此次數(shù)據(jù)調(diào)整一些工藝參數(shù)和設(shè)備操作，為正式工藝驗證提供可靠數(shù)據(jù)基礎(chǔ)，但開發(fā)批的產(chǎn)品必須檢驗全部符合質(zhì)量標(biāo)準(zhǔn)，且偏差得到有效調(diào)查評估后才可關(guān)閉。根據(jù)開發(fā)批驗證的數(shù)據(jù)修改SOP，并起草工藝驗證方案。 </p> <p> <p> 工藝驗證應(yīng)當(dāng)證明一個生產(chǎn)工藝按照規(guī)定的工藝參數(shù)能夠持續(xù)生產(chǎn)出符合預(yù)定用途和注冊要求的產(chǎn)品。在工藝驗證之前應(yīng)確定以下工作已完成: </p> <p> 1.所使用的設(shè)備或設(shè)施已完成安裝確認(rèn) (IQ) ，運(yùn)行確認(rèn) (OQ) 和性能確認(rèn)（PQ）； </p> <p> 2.產(chǎn)品的質(zhì)量標(biāo)準(zhǔn)已確定； </p> <p> 3.分析方法驗證已完成； </p> <p> 旦霆科技為企業(yè)提供工藝驗證GMP咨詢。 </p> 貴州生化分析儀驗證GMP咨詢</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(jī)構(gòu)的GMP認(rèn)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(xiàn)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/3007388.html</p></div></div></div></div></div><div id="war229y" class="page-right twoColRt"><div id="iwdfmof" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="mgcelb2" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/814588.html"><div><img 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