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src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312040869140/925739.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="upq3r3f" class="smallimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312040869140/925739.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="gja7r4s" 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GMP咨詢誠(chéng)信互利,GMP咨詢</p><p><span>***更新：</span>2021-01-16 01:04:46</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="yr2ariz" 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="dmy83lc" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="rqhv8nj" class="box"><p><p> 制藥行業(yè)常見(jiàn)生產(chǎn)設(shè)備清單 </p> <p> <br /> </p> <p> 我司目前已提供以下常見(jiàn)生產(chǎn)設(shè)備GMP咨詢： </p> <p> 無(wú)菌制劑：膠塞清洗機(jī)，理瓶機(jī)，洗瓶機(jī)（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(jī)器，凍干機(jī)（粉針），粉針?lè)盅b機(jī)器，軋蓋機(jī)，濕熱/敢惹滅菌器 </p> <p> 固體制劑：一步制粒機(jī)、濕法制粒機(jī)、混合機(jī)、膠囊填充機(jī)、壓片機(jī)、高效包衣機(jī)、數(shù)粒裝瓶機(jī)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(jī)械：鋁塑/鋁鋁包裝機(jī)、四面封包裝機(jī)、全自動(dòng)包裝線、裝盒機(jī)、激光打碼機(jī)，江蘇GMP咨詢誠(chéng)信互利，江蘇GMP咨詢誠(chéng)信互利，江蘇GMP咨詢誠(chéng)信互利、貼標(biāo)機(jī)等 </p> <p> <br /> 旦霆科技作為專(zhuān)業(yè)的GMP咨詢、第三方檢測(cè)供應(yīng)商，配備國(guó)外專(zhuān)業(yè)驗(yàn)證及檢測(cè)儀器,質(zhì)量可靠值得推薦!江蘇GMP咨詢誠(chéng)信互利</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江蘇GMP咨詢誠(chéng)信互利,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312040869140/925739.jpg"></div><p> 倉(cāng)儲(chǔ)物流系統(tǒng)簡(jiǎn)介 </p> <p> <p> 旦霆科技為企業(yè)提供倉(cāng)儲(chǔ)物流系統(tǒng)GMP咨詢，制藥企業(yè) 的產(chǎn) 品通過(guò) 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(cāng) 儲(chǔ) 物流系統(tǒng) 進(jìn) 行驗(yàn) 證成為關(guān) 注的重點(diǎn) 問(wèn) 題。IC H Q 7，《美國(guó)藥典》，中國(guó) GMP2010版都對(duì)藥品的倉(cāng)儲(chǔ)物流系統(tǒng)提出了相應(yīng)的法規(guī)需求。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(cāng)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(chóng)害控制以及安全；2. 對(duì)以下幾類(lèi)物料存儲(chǔ)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(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。 </p> 江蘇GMP咨詢誠(chéng)信互利旦霆科技不斷強(qiáng)化團(tuán)隊(duì)管理、服務(wù)升級(jí)，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)！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江蘇GMP咨詢誠(chéng)信互利,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312262041015/5554118.jpg"></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> 6. 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> <br /> </p><p> 工藝驗(yàn)證是什么，怎么做？ </p> <p> <p> 旦霆科技為企業(yè)提供工藝驗(yàn)證GMP咨詢。工藝驗(yàn)證應(yīng)當(dāng)證明一個(gè)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(cè)要求的產(chǎn)品。在工藝驗(yàn)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(yàn)證已完成； </p> <p> 工藝驗(yàn)證一般要求生產(chǎn)至少連續(xù)3批，對(duì)于新產(chǎn)品的工藝驗(yàn)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(gè)批號(hào)的開(kāi)發(fā)批工藝驗(yàn)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(yàn)證提供可靠數(shù)據(jù)基礎(chǔ)，但開(kāi)發(fā)批的產(chǎn)品必須檢驗(yàn)全部符合質(zhì)量標(biāo)準(zhǔn)，且偏差得到有效調(diào)查評(píng)估后才可關(guān)閉。根據(jù)開(kāi)發(fā)批驗(yàn)證的數(shù)據(jù)修改SOP，并起草工藝驗(yàn)證方案。 </p> 旦霆科技以高質(zhì)量、高性價(jià)比作為服務(wù)宗旨，為國(guó)內(nèi)制藥行業(yè)等眾多行業(yè)提供GMP咨詢及咨詢服務(wù)!</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="江蘇GMP咨詢誠(chéng)信互利,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312264707031/9318208.jpg"></div><p style="text-indent:25px">旦霆科技為企業(yè)提供生物制品生物學(xué)分析方法GMP咨詢。依照方法來(lái)源不同，驗(yàn)證的要求有所不同，標(biāo)準(zhǔn)方法）通常認(rèn)為在被確定為標(biāo)準(zhǔn)方法前巳經(jīng)過(guò)驗(yàn)證，使用者在采用此類(lèi)方法前只需證明實(shí)際使用條件下方法的適用性，對(duì)于非標(biāo)準(zhǔn)的方法通常需要經(jīng)過(guò)嚴(yán)格驗(yàn)證。一般情況下，需驗(yàn)證的分析項(xiàng)有：鑒別試驗(yàn)、純度和雜質(zhì)檢査、原液或制劑中有效成分的含量測(cè)定及生物活性測(cè)定。生物學(xué)測(cè)定方法依賴于生物基質(zhì)（如動(dòng)物、活細(xì)胞或目標(biāo)受體的功能復(fù)合體等）通常比化學(xué)實(shí)驗(yàn)變異性更大，主要的是生物活性（或效價(jià)、效力）測(cè)定。生物活性測(cè)定包括以下方法：1.動(dòng)物試驗(yàn)方法，2.在細(xì)胞水平上測(cè)定產(chǎn)品的生化和生理效應(yīng)的細(xì)胞培養(yǎng)檢測(cè)方法；3.利用酶反應(yīng)速率或免疫相互作用誘導(dǎo)的生物反應(yīng)等方法測(cè)定生物活性的生化檢測(cè)方法。旦霆科技年度營(yíng)業(yè)額以50%的速度高速增長(zhǎng)，成為為數(shù)不多的中大型GMP咨詢及驗(yàn)證測(cè)試服務(wù)的綜合性公司。江蘇GMP咨詢誠(chéng)信互利</p><p style="text-indent:25px">旦霆科技可提供GMP咨詢等驗(yàn)證檢測(cè)服務(wù)。廣納良言，吸取客戶有效意見(jiàn)、致力于為客戶更好的服務(wù)。江蘇GMP咨詢誠(chéng)信互利</p><p> 驗(yàn)證過(guò)程中對(duì)于儀表校準(zhǔn)常見(jiàn)問(wèn)題 </p> <p> <p> 旦霆科技為企業(yè)提供{GMP咨詢}/{GMP驗(yàn)證咨詢}中發(fā)現(xiàn)驗(yàn)證過(guò)程中儀表校準(zhǔn)常見(jiàn)偏差問(wèn)題如下： </p> <p> 1．儀器 /儀表精密度不符合要求；2. 需要校準(zhǔn) 的儀器 /儀表卻未進(jìn) 行校準(zhǔn)；3. 校準(zhǔn)證書(shū)的校準(zhǔn)范圍不符合用戶使用需求；4.新購(gòu) 儀器 /儀表無(wú) 相應(yīng) 的校準(zhǔn) 報(bào) 告或供應(yīng) 商提供的桕關(guān) 校準(zhǔn) 記錄5. 儀器 /儀表超過(guò) 校準(zhǔn) 日期，尚未校準(zhǔn) 仍在現(xiàn) 場(chǎng) 使用，未做任何處置；6. 校準(zhǔn)合格儀器/儀表無(wú)標(biāo) 識(shí) 或標(biāo) 識(shí) 破損、模糊，無(wú) 法識(shí) 別； 7.為儀器/儀表出具校準(zhǔn)證書(shū)的第三方機(jī)構(gòu)資質(zhì)不全或者資質(zhì)造假。 </p> 江蘇GMP咨詢誠(chéng)信互利</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(guò)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(lái)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(lái)源地址: http://www.cdcfah.com/cp/2862173.html</p></div></div></div></div></div><div id="2triplm" class="page-right twoColRt"><div id="7ntk8e7" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="yrievwx" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/814588.html"><div><img src="http://tyunfile.71360.com/UpLoadFile/2019/11/1/14/637082168864691056_lgpj_5374157.jpg" alt="福建ZF配件哪家強(qiáng) 信息推薦自業(yè)物資供應(yīng)" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></div><p>福建ZF配件哪家強(qiáng) 信息推薦自業(yè)物資供應(yīng)</p></a></div><div id="ei2wizv" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/846569.html"><div><img src="https://tyunfile.71360.com/WaterMark/UploadFile/nbzxsw/637298235378037109/764794.png" alt="寧波寧海直接考A2有幾個(gè)科目真誠(chéng)推薦寧波助學(xué)商務(wù)信息咨詢供應(yīng)" 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