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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>上海無塵車間驗(yàn)證咨詢公司,驗(yàn)證咨詢公司</p><p><span>***更新：</span>2021-01-11 01:04:42</p><p><span id="click" >瀏覽次數(shù)：2次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="aph8o3h" 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="u2iaczb" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="8xogdqx" class="box"><p><p> 驗(yàn)證參考的法規(guī)文獻(xiàn)有哪些？ </p> <p> <br /> </p> <p> GMP驗(yàn)證咨詢服務(wù)參考的法規(guī)/指南文件如下： </p> <p> <br /> </p> <p> (NMPA) 2010年版GMP及附錄確認(rèn)與驗(yàn)證 </p> <p> <br /> </p> <p> (NMPA) 2003藥品生產(chǎn)驗(yàn)證指南 </p> <p> <br /> </p> <p> (EU) 歐盟GMP附錄15:《確認(rèn)與驗(yàn)證》2015.10 </p> <p> <br /> </p> <p> (EMA)《制劑工藝驗(yàn)證指南-監(jiān)管性遞交需提供的信息和數(shù)據(jù)》2014.08 </p> <p> <br /> </p> <p> (FDA) 聯(lián)邦法規(guī)第21篇第210 211部分，成品藥的現(xiàn)行生產(chǎn)質(zhì)量管理規(guī)范 </p> <p> <br /> </p> <p> (FDA)《工藝驗(yàn)證：一般原則與慣例》2011.01 </p> <p> <br /> </p> <p> (PIC/S)GMP指南，藥用產(chǎn)品良好生產(chǎn)實(shí)踐指南 </p> <p> <br /> </p> <p> (PIC/S) 驗(yàn)證指南文件 </p> <p> <br /> </p> <p> (TGA)GMP，藥用產(chǎn)品良好生產(chǎn)實(shí)踐指南 </p> <p> <br /> </p> <p> (PDA)第60號(hào)技術(shù)報(bào)告：《工藝驗(yàn)證-一個(gè)生命周期方式》2013.02 </p> <p> <br /> </p> <p> (ISPE)指南第5卷：調(diào)試與確認(rèn)（2nd）2019，上海無塵車間驗(yàn)證咨詢公司.06 旦霆科技專業(yè)提供驗(yàn)證咨詢，上海無塵車間驗(yàn)證咨詢公司、CSV認(rèn)證及技術(shù)支持，上海無塵車間驗(yàn)證咨詢公司，**解答專業(yè)技術(shù)問題，歡迎您的垂詢！上海無塵車間驗(yàn)證咨詢公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="上海無塵車間驗(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> 什么是需求追溯矩陣，怎么做？ </p> <p> ISPE </p> <p> GAMP5《良好自動(dòng)化生產(chǎn)實(shí)踐指南-遵從GxP計(jì)算機(jī)化系統(tǒng)監(jiān)管的風(fēng)險(xiǎn)管理方法》提到：在系統(tǒng)生命周期的早期就應(yīng)該識(shí)別并糾正系統(tǒng)缺點(diǎn)，設(shè)計(jì)審査和可追溯性有助于保證系統(tǒng)符合預(yù)定用途，并且可以通過在早期識(shí)別缺點(diǎn)并解決問題來降低總體項(xiàng)目成本?！盙MP驗(yàn)證咨詢服務(wù)過程中，需求追溯性矩陣（Requirements </p> <p> traceability matrix, RTM)可與標(biāo)準(zhǔn)、要點(diǎn)和成果進(jìn)行比較，對(duì)特定問題點(diǎn)提出必要的糾正措施。 </p> <p> 需求追溯矩陣可起到如下作用： </p> <p> 1.設(shè)計(jì)需求經(jīng)過了驗(yàn)證，并可以追溯到表明需求得到滿足的測(cè)試或驗(yàn)證活動(dòng)； </p> <p> 2.使得風(fēng)險(xiǎn)管理和設(shè)計(jì)審査流程更有效率； </p> <p> 判斷所提交的變更需求會(huì)產(chǎn)生什么樣的影響； </p> <p> 3.有助于對(duì)所提交的變更進(jìn)行風(fēng)險(xiǎn)評(píng)估； </p> <p> 4.確認(rèn)對(duì)變更進(jìn)行測(cè)試的范圍； </p> <p> 5.可在檢査和審査時(shí)快速準(zhǔn)確地反應(yīng)。上海無塵車間驗(yàn)證咨詢公司旦霆科技擁有專業(yè)的驗(yàn)證及檢測(cè)服務(wù)團(tuán)隊(duì)、專業(yè)提供CSV證等服務(wù)，因?yàn)閷I(yè)所以值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="上海無塵車間驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431524472656/9507670.png"></div><p> 什么是4Q? </p> <p> 關(guān)于儀器驗(yàn)證，比如說，一套完整的儀器設(shè)備驗(yàn)證方案，將包括4個(gè)部分，即4Q，分別為： </p> <p> DQ，設(shè)計(jì)確認(rèn)：確認(rèn)設(shè)備的設(shè)計(jì)符合用戶需求規(guī)范及相關(guān)法規(guī)。 </p> <p> IQ，安裝確認(rèn)：確認(rèn)儀器文件、部件及安裝過程。 </p> <p> OQ，運(yùn)行確認(rèn)：確認(rèn)儀器在空轉(zhuǎn)狀態(tài)下，在操作的極限范圍內(nèi)能正常的運(yùn)轉(zhuǎn)。 </p> <p> PQ，性能確認(rèn)：確認(rèn)儀器載樣運(yùn)行下是否符合標(biāo)準(zhǔn)規(guī)定。 </p> <p> <p> 什么是3Q? </p> <p> 由于實(shí)驗(yàn)室所用儀器均有儀器廠家研發(fā)設(shè)計(jì)而成，因此DQ(設(shè)計(jì)確認(rèn))在儀器驗(yàn)證中可以不做，所以本文提到的3Q，是指以上IQ(安裝確認(rèn))、OQ(運(yùn)行確認(rèn))、PQ(性能確認(rèn))。 </p> <p> 也就是說實(shí)驗(yàn)室儀器驗(yàn)證是從IQ(安裝確認(rèn))做起，再做OQ(運(yùn)行確認(rèn))、PQ(性能確認(rèn))，就完成了一套儀器驗(yàn)證的整套資料。 </p> </p><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)需求旦霆科技作為國(guó)內(nèi)**大中型規(guī)模綜合性咨詢服務(wù)公司，專業(yè)提供計(jì)算機(jī)化系統(tǒng)驗(yàn)證服務(wù)，值得信賴！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="上海無塵車間驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431532265625/5596974.png"></div><p> 壓縮空氣系統(tǒng)驗(yàn)證內(nèi)容 </p> <p> 旦霆科技為企業(yè)提供壓縮空氣系統(tǒng)GMP驗(yàn)證咨詢，驗(yàn)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(rèn)（圖紙確認(rèn)/技術(shù)文件確認(rèn)/材質(zhì)證明類文件確認(rèn)/施工記錄/報(bào)告確認(rèn)）,系統(tǒng)安裝環(huán)境確認(rèn), 儀器儀表校準(zhǔn)確認(rèn),部件信息及安裝確認(rèn)，公用介質(zhì)連接確認(rèn), 標(biāo)識(shí)確認(rèn)；OQ內(nèi)容包含：系統(tǒng)啟動(dòng)和關(guān)閉，系統(tǒng)安全確認(rèn)，權(quán)限確認(rèn)，按鍵確認(rèn)，參數(shù)設(shè)置功能確認(rèn)，噪聲確認(rèn)，歷史故障記錄確認(rèn)，斷電/恢復(fù)確認(rèn)；PQ內(nèi)容包括：水分測(cè)試，含油量測(cè)試，固體顆粒測(cè)試以及微生物測(cè)試，測(cè)試執(zhí)行3次 </p> <p> <br /> </p> <p> <br /> 旦霆科技作為專業(yè)的計(jì)算機(jī)化系統(tǒng)驗(yàn)證服務(wù)，配備國(guó)外專業(yè)驗(yàn)證及檢測(cè)儀器，數(shù)據(jù)真實(shí)、質(zhì)量可靠值得推薦!上海無塵車間驗(yàn)證咨詢公司</p><p style="text-indent:25px">旦霆科技作為專業(yè)的CSV驗(yàn)證及第三方檢測(cè)供應(yīng)商，取得良好的客戶口碑，我們繼續(xù)保持高水準(zhǔn)服務(wù)全國(guó)。上海無塵車間驗(yàn)證咨詢公司</p><p> "回顧性驗(yàn)證怎么做 </p> <p> <br /> </p> <p> GMP驗(yàn)證咨詢服務(wù)中，回顧驗(yàn)證必須具備以下條件方可應(yīng)用： </p> <p> <br /> </p> <p> 1.至少有6批符合要求的數(shù)據(jù)，有20批以上的數(shù)據(jù)更好。 </p> <p> <br /> </p> <p> 2.檢驗(yàn)方法已經(jīng)過驗(yàn)證，檢驗(yàn)的結(jié)果可以用數(shù)值表示，可以進(jìn)行統(tǒng)計(jì)分析。 </p> <p> <br /> </p> <p> 3.批記錄符合制藥GMP要求，記錄中有明確的工藝條件，且有關(guān)于偏差的分析說明。 </p> <p> <br /> </p> <p> 4.有關(guān)的工藝變量是標(biāo)準(zhǔn)化的，并一直處于控制狀態(tài)，如原料標(biāo)準(zhǔn)、潔凈區(qū)的級(jí)別、分析方法、微生物控制等。 </p> <p> <br /> </p> <p> 5.這種方式通常用于非無菌產(chǎn)品的工藝驗(yàn)證，以積累的生產(chǎn)、檢驗(yàn)和其他有關(guān)歷史資料為依據(jù)，回顧、分析工藝控制的全過程，證實(shí)其控制條件的有效件。" </p> <p> <br /> 上海無塵車間驗(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://m.cdcfah.com/cp/2789517.html</p></div></div></div></div></div><div id="xhew2in" class="page-right twoColRt"><div id="3dkxpme" class="box01 margin10 clearfix"><h3><a href="http://m.cdcfah.com/cp/">猜你喜歡</a></h3><div id="3i8dfxe" class="recomPic likePro"><a href="http://m.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="akxpwyv" class="recomPic likePro"><a href="http://m.cdcfah.com/cp/846569.html"><div><img src="https://tyunfile.71360.com/WaterMark/UploadFile/nbzxsw/637298235378037109/764794.png" 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