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clearfix"><p class="current"> 當(dāng)前位置:<a href="http://www.cdcfah.com/">首頁?<a href="http://www.cdcfah.com/cp/">產(chǎn)品供應(yīng)</a>?<a href="http://www.cdcfah.com/cp/first-_yyby/">醫(yī)藥健康</a>?<a href="http://www.cdcfah.com/cp/second-yyby_swzp/">生物制品</a>?<a href="http://www.cdcfah.com/cp/third-swzp_qtswzp/">其他生物制品</a>?江蘇血細(xì)胞分析儀驗(yàn)證咨詢公司誠(chéng)信服務(wù) 旦霆生物科技供應(yīng)</p><div id="znpm2cq" class="leftbox clearfix"><h1>江蘇血細(xì)胞分析儀驗(yàn)證咨詢公司誠(chéng)信服務(wù) 旦霆生物科技供應(yīng)</h1><div id="cldk9vx" class="proBig"><div id="3iprb8k" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431513359375/9658238.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="qumoy4w" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431513359375/9658238.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="ckhewam" class="content"><p><span>需求數(shù)量：</span>0</p><p><span>價(jià)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>江蘇血細(xì)胞分析儀驗(yàn)證咨詢公司,驗(yàn)證咨詢公司</p><p><span>***更新：</span>2021-01-18 01:04:15</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="rkr7np2" 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(hào)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="mvxe2fm" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="y3nebq4" class="box"><p><p> 什么是驗(yàn)證總結(jié)報(bào)告，怎么做？ </p> <p> 在GMP驗(yàn)證咨詢服務(wù)確認(rèn)程序的** 后階段應(yīng)完成確認(rèn)總結(jié)報(bào)告。這個(gè)報(bào)告的目的是總結(jié)和**終審核所有可能存在問題的確認(rèn)活動(dòng)以及出現(xiàn)的偏差。確認(rèn)總結(jié)報(bào)告** 后，應(yīng)正式說明系統(tǒng)準(zhǔn)予放行，可進(jìn)行GMP相關(guān)的生產(chǎn)活動(dòng)。滿足以下條件，本系統(tǒng)即可批準(zhǔn)正式放行： </p> <p> 1. 所有的測(cè)試均執(zhí)行完成，所有的確認(rèn)報(bào)告（DQ, CCA,RA,IQ, OQ, PQ）被批準(zhǔn)； </p> <p> 2. 如有必要，應(yīng)通過追蹤矩陣、檢查清單等方式證實(shí)所有的URS已得到滿足； </p> <p> 3. 所有的偏差均被糾正和關(guān)閉； </p> <p> 4. 如果只有微小偏差沒有關(guān)閉，只能生成一個(gè)臨時(shí)的總結(jié)報(bào)告，這種情況下可以接受該系統(tǒng)限制性放行，并可用于GMP操作。當(dāng)所有偏差被關(guān)閉后，批準(zhǔn)**終的驗(yàn)證總結(jié)報(bào)告； </p> <p> 當(dāng)每個(gè)系統(tǒng)驗(yàn)證總結(jié)報(bào)告均被批準(zhǔn)之后，整個(gè)項(xiàng)目的確認(rèn)活動(dòng)宣告完成，并可以投入應(yīng)用于GMP相關(guān)的生產(chǎn)操作，江蘇血細(xì)胞分析儀驗(yàn)證咨詢公司，江蘇血細(xì)胞分析儀驗(yàn)證咨詢公司。在驗(yàn)證主報(bào)告中應(yīng)該描述性的總結(jié)所有相關(guān)系統(tǒng)的狀況，江蘇血細(xì)胞分析儀驗(yàn)證咨詢公司，確保沒有遺漏任何一個(gè)GMP相關(guān)或生物安全相關(guān)的系統(tǒng). 旦霆科技在提供高質(zhì)量服務(wù)的同時(shí)為眾多客戶解決項(xiàng)目偏差、驗(yàn)證偏差等問題。以保證3Q認(rèn)證服務(wù)的順利進(jìn)行。江蘇血細(xì)胞分析儀驗(yàn)證咨詢公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江蘇血細(xì)胞分析儀驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431513359375/9658238.jpg"></div><p> 旦霆科技為企業(yè)提供倉儲(chǔ)物流系統(tǒng)GMP驗(yàn)證咨詢，。IS P E 冷鏈管理中對(duì)藥品的冷鏈則提出了具體的質(zhì)量計(jì)劃，從倉儲(chǔ)運(yùn)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(hù)，蟲害控制以及安全；2. 對(duì)以下幾類物料存儲(chǔ)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(duì)物料存儲(chǔ)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；3.對(duì)溫度受控區(qū)域的控制：規(guī)范要求，產(chǎn)品數(shù)據(jù)，相應(yīng)的清潔，維護(hù)，校準(zhǔn)，確認(rèn)，監(jiān)控，報(bào)警流程，廢料處理等，4.運(yùn)輸：運(yùn) 輸方法的制定和驗(yàn)證，供應(yīng) 商審計(jì)，供應(yīng) 商性能確認(rèn)/ 監(jiān) 測(cè)，貨物檢測(cè) / 性能監(jiān)測(cè)等等。制藥企業(yè)的產(chǎn)品通過生產(chǎn) 、存儲(chǔ) 、運(yùn)輸及交付，**終才能到達(dá) 患者的手中，為保證患者的安全，如何對(duì)制藥企業(yè)的倉儲(chǔ)物流系統(tǒng) 進(jìn)行驗(yàn)證成為關(guān)注的重點(diǎn)問題。ICHQ7，《美國(guó)藥典》，中國(guó)GMP2010版都對(duì)藥品的倉儲(chǔ)物流系統(tǒng)提出了相應(yīng)的法規(guī)需求江蘇血細(xì)胞分析儀驗(yàn)證咨詢公司旦霆科技配備幾百套驗(yàn)證及檢測(cè)儀器，專業(yè)的驗(yàn)證及檢測(cè)服務(wù)團(tuán)隊(duì)，專業(yè)提供驗(yàn)證服務(wù)，服務(wù)區(qū)域覆蓋全國(guó)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江蘇血細(xì)胞分析儀驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431491503906/5150702.png"></div><p> 清潔驗(yàn)證方案制定應(yīng)重點(diǎn)考慮以下內(nèi)容： </p> <p> 1．參照物質(zhì)與**難清潔物質(zhì)選擇； </p> <p> 2． **難清潔部位和取樣點(diǎn)選擇； </p> <p> 3．殘留物限度的確定 </p> <p> 4．殘留溶劑的限度標(biāo)準(zhǔn) </p> <p> 5．微生物污染控制標(biāo)準(zhǔn) </p> <p> <br /> </p> <p> 取樣與檢驗(yàn)方法學(xué) </p> <p> 旦霆科技為企業(yè)提供清潔驗(yàn)證方案GMP驗(yàn)證咨詢。在藥品生產(chǎn) 的每道工序完成后，對(duì) 制藥設(shè) 備進(jìn) 行淸洗是防止藥品污染和交叉污染的必要手段, 嚴(yán) 格地講，*** 意義上的、不含任何殘留物的清潔狀態(tài) 是不存在的, 設(shè) 備的清潔程度，取決于殘留物的性質(zhì) 、設(shè) 備的結(jié) 構(gòu) 、材質(zhì) 和清洗的方法。 </p><p> 儀器校正相關(guān)規(guī)定 </p> <p> <br /> </p> <p> 實(shí)驗(yàn)室的儀器設(shè)備種類相當(dāng)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(cè)等事宜，以做為產(chǎn)品放行或向主管機(jī)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(jì)劃，訂立合理的校正周期，定期以標(biāo)準(zhǔn)品對(duì)這些儀器設(shè)備進(jìn)行測(cè)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(biāo)準(zhǔn)品的選定必須是可回溯的，在校正的動(dòng)作完成之后，必須在這類儀器上貼上“校正標(biāo)”，標(biāo)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(shí)驗(yàn)室中為數(shù)**多。 </p> <p> <br /> </p> <p> 例如：HPLC、UV/VIS、FTIR、AA、旋光度計(jì)、天平、熒光光譜儀、自動(dòng)滴定儀、崩散度計(jì)、磨損度計(jì)及烘箱等。 </p> <p> <br /> </p> <p> 這些儀器必須按照既定的校正計(jì)劃嚴(yán)格執(zhí)行校正，若發(fā)現(xiàn)該儀器有偏離校正容許范圍時(shí)，校正者應(yīng)發(fā)出正式之通告，并循標(biāo)準(zhǔn)程序排除障礙。 </p> <p> <br /> 旦霆科技致力于質(zhì)量?jī)?yōu)、人員佳、信價(jià)比高的質(zhì)量服務(wù)，為制藥行業(yè)等企業(yè)提供CSV驗(yàn)證及檢測(cè)服務(wù)和咨詢。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江蘇血細(xì)胞分析儀驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431513242187/8526534.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(jī)系統(tǒng) </p> <p> 旦霆科技為企業(yè)提供生物制品工藝驗(yàn)證GMP驗(yàn)證咨詢，按照工藝流程： </p> <p> 細(xì)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(xì)胞計(jì)數(shù)儀，流式細(xì)胞儀，程序降溫儀等； </p> <p> 細(xì)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(xì)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(jī)，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)；旦霆科技保證測(cè)試驗(yàn)證數(shù)據(jù)真實(shí)、測(cè)試人員專業(yè)、性價(jià)比高。為客戶提供CSV驗(yàn)證服務(wù)及技術(shù)咨詢！江蘇血細(xì)胞分析儀驗(yàn)證咨詢公司</p><p style="text-indent:25px">旦霆科技是國(guó)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(rèn)證服務(wù)的專業(yè)第三方咨詢公司。江蘇血細(xì)胞分析儀驗(yàn)證咨詢公司</p><p> 什么是SRA，怎么做（是否與RA合并） </p> <p> GMP驗(yàn)證咨詢服務(wù)過程中系統(tǒng)風(fēng)險(xiǎn)評(píng)估（SRA）是通過QRM檢驗(yàn)直接影響系統(tǒng)的產(chǎn)品質(zhì)量風(fēng)險(xiǎn)控制措施的應(yīng)用，執(zhí)行系統(tǒng)風(fēng)險(xiǎn)評(píng)估的項(xiàng)目團(tuán)隊(duì)?wèi)?yīng)包含能理解工藝和相關(guān)CQAs的相關(guān)風(fēng)險(xiǎn)的主題技術(shù)**（SMEs）。（對(duì)于標(biāo)準(zhǔn)的現(xiàn)成的或簡(jiǎn)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(xiǎn)評(píng)估；可使用簡(jiǎn)單的協(xié)議或報(bào)告（例如，安裝和運(yùn)行驗(yàn)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(xiǎn)評(píng)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(yàn)收和放行涉及確認(rèn)系統(tǒng)風(fēng)險(xiǎn)評(píng)估中確定的控制措施如下: </p> <p> 1.已經(jīng)證明設(shè)計(jì)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 /> 江蘇血細(xì)胞分析儀驗(yàn)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(yàn)證服務(wù)以及培訓(xùn)的綜合性咨詢公司； </p> <p> 旦霆公司長(zhǎng)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(guó)內(nèi)**的第三方檢測(cè)公司。 </p> <p> 作為以慈善事業(yè)為使命的旦霆公司堅(jiān)持以超值的品質(zhì)為客戶提供服務(wù)，同時(shí)公司每年利潤(rùn)的10%捐獻(xiàn)給中國(guó)貧困兒童，持久資助中國(guó)貧困兒童的教育。 </p></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/2890625.html</p></div></div></div></div></div><div id="3oqikbq" class="page-right twoColRt"><div id="hgd7e8u" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="2r37r2j" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/814588.html"><div><img 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