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onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="tr3vmi9" 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>河北生化培養(yǎng)箱驗(yàn)證咨詢公司,驗(yàn)證咨詢公司</p><p><span>***更新：</span>2021-01-09 06:05:09</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="huiokg9" 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="dlxok2z" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="omievgp" class="box"><p><p> 常見(jiàn)驗(yàn)證文件并釋意 </p> <p> GMP驗(yàn)證咨詢服務(wù)常見(jiàn)驗(yàn)證交付物釋意如下：用戶需求（URS）：指使用方對(duì)廠房、設(shè)施、設(shè)備或其他系統(tǒng)提出的要求及期望；驗(yàn)證總計(jì)劃（VMP）：是對(duì)整個(gè)驗(yàn)證計(jì)劃的概述；驗(yàn)證計(jì)劃（VP）：針對(duì)于大型復(fù)雜項(xiàng)目，驗(yàn)證總計(jì)劃將整個(gè)項(xiàng)目再劃分成多個(gè)小項(xiàng)目，按照其特點(diǎn)來(lái)編寫驗(yàn)證計(jì)劃和方案；風(fēng)險(xiǎn)評(píng)估（RA）：一種用于評(píng)估并描述系統(tǒng)、設(shè)備或工藝的關(guān)鍵方面（CQA/CPP），以確定系統(tǒng)、設(shè)備驗(yàn)證的范圍和程度的方法；設(shè)計(jì)確認(rèn)（DQ）：在設(shè)備建造前，對(duì)設(shè)備設(shè)計(jì)文件（用戶需求說(shuō)明、功能設(shè)計(jì)說(shuō)明、詳細(xì)設(shè)計(jì)說(shuō)明等）進(jìn)行檢査確保能夠完全滿足用戶需求說(shuō)明及GMP中的所有要求；安裝確認(rèn)（IQ）：為確認(rèn)安裝或改造后的設(shè)施，河北生化培養(yǎng)箱驗(yàn)證咨詢公司、系統(tǒng)和設(shè)備符合已批準(zhǔn)的設(shè)計(jì)及制造商建議所作的各種查證及文件記錄，新的或改造的廠房、設(shè)施、設(shè)備需進(jìn)行安裝確認(rèn)；運(yùn)行確認(rèn)（OQ）：應(yīng)當(dāng)證明廠房、設(shè)施、設(shè)備的運(yùn)行符合設(shè)計(jì)標(biāo)準(zhǔn)；性能確認(rèn)（PQ）：性能確認(rèn)目的在于證明廠房、設(shè)施、設(shè)備在正常操作方法和工藝條件下能夠持續(xù)符合標(biāo)準(zhǔn)，性能確認(rèn)方案的制定應(yīng)依據(jù)已有的生產(chǎn)工藝，河北生化培養(yǎng)箱驗(yàn)證咨詢公司，河北生化培養(yǎng)箱驗(yàn)證咨詢公司、設(shè)施和設(shè)備的相關(guān)知識(shí)，使用生產(chǎn)物料、適當(dāng)?shù)奶娲坊蛘吣M產(chǎn)品來(lái)進(jìn)行試驗(yàn)/測(cè)試；需求追溯矩陣。旦霆科技不但擁有龐大的驗(yàn)證及檢測(cè)團(tuán)隊(duì)，同時(shí)配備幾百套驗(yàn)證及檢測(cè)儀器，專業(yè)開(kāi)展CSV驗(yàn)證服務(wù)！河北生化培養(yǎng)箱驗(yàn)證咨詢公司</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北生化培養(yǎng)箱驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431490947265/9085575.png"></div><p> 倉(cāng)儲(chǔ)物流系統(tǒng)簡(jiǎn)介 </p> <p> 旦霆科技為企業(yè)提供倉(cāng)儲(chǔ)物流系統(tǒng)GMP驗(yàn)證咨詢，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<span style="display:none;"></span>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。ICHQ7，《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。ISPE<span style="display:none;"></span>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； </p> <p> 2. 對(duì)以下幾類物料存儲(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； </p> <p> 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， </p> <p> 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。河北生化培養(yǎng)箱驗(yàn)證咨詢公司旦霆科技積極聽(tīng)取客戶有效意見(jiàn)，不斷完善質(zhì)量體系及服務(wù)理念，為質(zhì)量提供3Q認(rèn)證服務(wù)奠定了基礎(chǔ)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北生化培養(yǎng)箱驗(yàn)證咨詢公司,驗(yàn)證咨詢公司" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637188431525898437/6717066.png"></div><p> 驗(yàn)證過(guò)程中對(duì)于儀表校準(zhǔn)常見(jiàn)問(wèn)題 </p> <p> 旦霆科技為企業(yè)提供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； </p> <p> 2. 需要校準(zhǔn) 的儀器 /儀表卻未進(jìn) 行校準(zhǔn)； </p> <p> 3.校準(zhǔn)證書的校準(zhǔn)范圍不符合用戶使用需求； </p> <p> 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 </p> <p> 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； </p> <p> 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； </p> <p> 7.為儀器/儀表出具校準(zhǔn)證書的第三方機(jī)構(gòu)資質(zhì)不全或者資質(zhì)造假。 </p><p> 生物學(xué)測(cè)定方法驗(yàn)證 </p> <p> 旦霆科技為企業(yè)提供生物制品生物學(xué)分析方法GMP驗(yàn)證咨詢，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。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。旦霆科技不斷強(qiáng)化團(tuán)隊(duì)管理、品牌價(jià)值及服務(wù)升級(jí)，以質(zhì)量的理念為企業(yè)提供高水準(zhǔn)的CSV驗(yàn)證服務(wù)！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北生化培養(yǎng)箱驗(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> 什么是用戶需求，用戶需求包含什么內(nèi)容？ </p> <p> GMP驗(yàn)證咨詢服務(wù)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(duì)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(duì)所有用戶需求進(jìn)行編號(hào)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(yàn)證的基礎(chǔ)。用戶需求編制時(shí)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(jì)規(guī)范和詳細(xì)設(shè)計(jì)規(guī)范中。旦霆科技擁有先進(jìn)的驗(yàn)證理念，成熟的驗(yàn)證體系，為您提供專業(yè)、質(zhì)量的計(jì)算機(jī)化系統(tǒng)驗(yàn)證服務(wù)。河北生化培養(yǎng)箱驗(yàn)證咨詢公司</p><p style="text-indent:25px">旦霆科技配備數(shù)十人的驗(yàn)證及檢測(cè)團(tuán)隊(duì)，承接國(guó)內(nèi)各類相關(guān)企業(yè)的CSV驗(yàn)證、第三方驗(yàn)證或檢測(cè)及咨詢服務(wù)。河北生化培養(yǎng)箱驗(yàn)證咨詢公司</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. 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； </p> <p> 2.為儀器/儀表出具校準(zhǔn)證書的第三方機(jī)構(gòu)資質(zhì)不全或者資質(zhì)造假。 </p> <p> 3．儀器 /儀表精密度不符合要求；4. 需要校準(zhǔn) 的儀器 /儀表卻未進(jìn) 行校準(zhǔn)；5. </p> <p> 校準(zhǔn)證書的校準(zhǔn)范圍不符合用戶使用需求；6.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7. </p> <p> 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；河北生化培養(yǎng)箱驗(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(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: 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