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#f30;"></span></p><p><span>產(chǎn)品關(guān)鍵詞：</span>安徽CO2分配系統(tǒng)驗證GMP咨詢,GMP咨詢</p><p><span>***更新：</span>2021-01-12 10:06:56</p><p><span id="click" >瀏覽次數(shù)：3次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="fc7wnzu" 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(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="nf3uqhh" class="page-proshow02"><p class="title">詳細說明</p><div id="8rsef3h" class="box"><p><p> 驗證交付物包括VP，SC，SRA，IQ，OQ，PQ，RTM以及VSR文件,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)安裝環(huán)境確認, 儀器儀表校準(zhǔn)確認,部件信息及安裝確認，公用介質(zhì)連接確認, 標(biāo)識確認；OQ內(nèi)容包含：系統(tǒng)啟動和關(guān)閉，系統(tǒng)安全確認，權(quán)限確認，安徽CO2分配系統(tǒng)驗證GMP咨詢，按鍵確認，參數(shù)設(shè)置功能確認，噪聲確認，歷史故障記錄確認，斷電/恢復(fù)確認；PQ內(nèi)容包括：水分測試，含油量測試，固體顆粒測試以及微生物測試，安徽CO2分配系統(tǒng)驗證GMP咨詢，測試執(zhí)行3次 </p> <p> 旦霆科技為企業(yè)提供壓縮空氣系統(tǒng)GMP咨詢。旦霆科技提供技術(shù)咨詢、GMP咨詢，安徽CO2分配系統(tǒng)驗證GMP咨詢、驗證及檢測服務(wù)。在您不知道具體項目需求時為您擇優(yōu)推薦！安徽CO2分配系統(tǒng)驗證GMP咨詢</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽CO2分配系統(tǒng)驗證GMP咨詢,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312036142578/5616514.jpg"></div><p> 什么是系統(tǒng)分類（SC），怎么做？ </p> <p> ISPE基準(zhǔn)指南卷5《調(diào)試與確認》(2019）中列出以下8個問題將系統(tǒng)分為直接影響系統(tǒng)和間接影響系統(tǒng)，如其中一個問題回答為”是”，則改系統(tǒng)應(yīng)判定為直接影響系統(tǒng)，我司可提供3Q認證；：1.系統(tǒng)是否包含CAs/CDEs或執(zhí)行滿足包括CPPs在內(nèi)的一個或多個流程需求(CQAs)的功能?2.系統(tǒng)是否與產(chǎn)品或生產(chǎn)流程有直接接觸，并且這種接觸有可能影響**終產(chǎn)品質(zhì)量或?qū)颊邩?gòu)成風(fēng)險?3.該系統(tǒng)是否提供輔料或生產(chǎn)成分或溶劑(如WFI)，以及該物質(zhì)的質(zhì)量(以其質(zhì)量標(biāo)準(zhǔn)而論)是否會影響**終產(chǎn)品質(zhì)量或?qū)颊邩?gòu)成風(fēng)險?4.系統(tǒng)是否用于清潔、消毒或滅菌，系統(tǒng)故障是否會導(dǎo)致無法充分清潔、消毒或滅菌，從而給患者帶來風(fēng)險?5.系統(tǒng)建立一個適當(dāng)?shù)沫h(huán)境(如氮氣保護，密閉流程，暴露灌裝區(qū)區(qū)空氣質(zhì)量，維持產(chǎn)品溫濕度等等產(chǎn)品關(guān)鍵工藝參數(shù))，這前列程失效情況下，其功能會導(dǎo)致患者健康的風(fēng)險?6.系統(tǒng)是否使用、生產(chǎn)、處理或存儲用于接受或拒絕產(chǎn)品、CPPS 或電子記錄的數(shù)據(jù)，以符合 21CFR第11部和歐盟 GMP 第 4 卷第 11部[21]或本地同等標(biāo)準(zhǔn)?7.該系統(tǒng)是否提供容器封口或產(chǎn)品保護，如果封口或產(chǎn)品保護失敗，將對患者構(gòu)成風(fēng)險或產(chǎn)品質(zhì)量下降? 安徽CO2分配系統(tǒng)驗證GMP咨詢旦霆科技保證測試驗證數(shù)據(jù)真實、測試人員專業(yè)、性價比高。為客戶提供GMP咨詢服務(wù)及技術(shù)咨詢！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽CO2分配系統(tǒng)驗證GMP咨詢,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175311838671875/7440718.jpg"></div><p> 空調(diào)系統(tǒng)與潔凈室驗證內(nèi)容 </p> <p> 旦霆科技為企業(yè)提供空調(diào)系統(tǒng)與潔凈廠房GMP咨詢，驗證交付物包括VP，SC，SRA，IQ，OQ，PQ，RTM以及VSR文件，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(zhǔn)確認, 潔凈區(qū)安裝確認, 空調(diào)系統(tǒng)部件安裝確認，PLC及HMI確認，標(biāo)識確認以及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，報警確認，斷電恢復(fù)確認，自動運行確認，風(fēng)量及換氣次數(shù)確認測，壓差確認，高效過濾器及邊框完整性確認，溫度/相對濕度確，噪音確認測，照度確認，氣流流型確認，自凈時間確認，懸浮粒子確認，浮游菌確認，沉降菌確認；PQ內(nèi)容包括：溫度/相對濕度確認，懸浮粒子確認，浮游菌確認，沉降菌確認測試以及表面微生物，動態(tài)執(zhí)行三次。 </p><p> 制藥行業(yè)常見生產(chǎn)設(shè)備清單 </p> <p> <br /> </p> <p> 我司目前已提供以下常見生產(chǎn)設(shè)備GMP咨詢： </p> <p> 無菌制劑：膠塞清洗機，理瓶機，洗瓶機（噴淋式，噴射式，超聲洗滌），隧道烘箱，電熱烘箱，配液系統(tǒng)，灌封機器，凍干機（粉針），粉針分裝機器，軋蓋機，濕熱/敢惹滅菌器 </p> <p> 固體制劑：一步制粒機、濕法制粒機、混合機、膠囊填充機、壓片機、高效包衣機、數(shù)粒裝瓶機等 </p> <p> 生物制劑/中藥提?。荷锓磻?yīng)器、發(fā)酵罐、培養(yǎng)罐、中藥提取系統(tǒng)、蛋白純化系統(tǒng)等 </p> <p> 包裝機械：鋁塑/鋁鋁包裝機、四面封包裝機、全自動包裝線、裝盒機、激光打碼機、貼標(biāo)機等 </p> <p> <br /> 旦霆科技為制藥行業(yè)等企業(yè)提供GMP咨詢及驗證測試服務(wù)。對耗材供應(yīng)商進行年審、為項目把好關(guān)！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="安徽CO2分配系統(tǒng)驗證GMP咨詢,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312262080078/3685544.jpg"></div><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> <p> 旦霆科技為企業(yè)提供生物制品工藝驗證GMP咨詢，按照工藝流程： </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> 旦霆科技積極聽取客戶有效意見，不斷完善質(zhì)量體系及服務(wù)理念，為質(zhì)量提供GMP咨詢服務(wù)奠定了基礎(chǔ)。安徽CO2分配系統(tǒng)驗證GMP咨詢</p><p style="text-indent:25px">旦霆科技專業(yè)提供GMP咨詢，服務(wù)面向全國，至今為各大制藥企業(yè)、外企、上市公司提供質(zhì)量服務(wù)。安徽CO2分配系統(tǒng)驗證GMP咨詢</p><p> 驗證交付物包括VP，SC，SRA，IQ，OQ，PQ，RTM以及VSR文件，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(zhǔn)確認, 潔凈區(qū)安裝確認, 空調(diào)系統(tǒng)部件安裝確認，PLC及HMI確認，標(biāo)識確認以及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，報警確認，斷電恢復(fù)確認，自動運行確認，風(fēng)量及換氣次數(shù)確認測，壓差確認，高效過濾器及邊框完整性確認，溫度/相對濕度確，噪音確認測，照度確認，氣流流型確認，自凈時間確認，懸浮粒子確認，浮游菌確認，沉降菌確認；PQ內(nèi)容包括：溫度/相對濕度確認，懸浮粒子確認，浮游菌確認，沉降菌確認測試以及表面微生物，動態(tài)執(zhí)行三次。 </p> <p> 旦霆科技為企業(yè)提供空調(diào)系統(tǒng)與潔凈廠房GMP咨詢}。安徽CO2分配系統(tǒng)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等機構(gòu)的GMP認證檢查； </p> <p> 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