四川庫存管理軟件滅菌柜驗(yàn)證第三方誠信服務(wù) 旦霆生物科技供應(yīng)-b2b網(wǎng)站_b2b電子商務(wù)平臺(tái)【買產(chǎn)品】-上?？谄蚴称酚邢薰?/title><meta name="description" content="性能確認(rèn)中應(yīng)注意以下幾點(diǎn)：一、流量、壓力和溫度等檢測(cè)儀器必須經(jīng)過校驗(yàn)并在校驗(yàn)期內(nèi)；二、制定詳細(xì)的取樣計(jì)劃、化驗(yàn)方法并得到相關(guān)部門的批準(zhǔn)；三、性能確認(rèn)時(shí)至少應(yīng)制定好BPR（BatchProductionRecord，即空白批記錄），四川庫存管"><meta name="keywords" content="四川庫存管理軟件滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證"><link rel="canonical" href="http://www.cdcfah.com/"/><meta name="applicable-device" content="pc"><link rel="shortcut icon" href="/static/new_net_01/images/favicon.ico"><link rel="stylesheet" href="/static/new_net_01/css/slick.css" /><link rel="stylesheet" href="/static/new_net_01/css/addnew.css"><link rel="stylesheet" href="/static/new_net_01/css/sidenav.css"><link rel="stylesheet" href="/static/new_net_01/css/style.css" /><link rel="stylesheet" href="/static/new_net_01/css/tab.css"><link rel="stylesheet" href="/static/new_net_01/css/404.css"> <meta name="baidu-site-verification" 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href="http://www.cdcfah.com/cp/third-yyby_qtflft/">其他未分類</a>?四川庫存管理軟件滅菌柜驗(yàn)證第三方誠信服務(wù) 旦霆生物科技供應(yīng)</p><div id="u700qzn" class="leftbox clearfix"><h1>四川庫存管理軟件滅菌柜驗(yàn)證第三方誠信服務(wù) 旦霆生物科技供應(yīng)</h1><div id="fwq87ux" class="proBig"><div id="whbsrkj" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294992236329/5059315.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="xtnra83" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294992236329/5059315.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="i7p88kt" 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>四川庫存管理軟件滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證</p><p><span>***更新：</span>2020-12-19 06:04:55</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="mihgky3" 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="m2zq3a8" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="b7fonwf" class="box"><p><p> 性能確認(rèn)中應(yīng)注意以下幾點(diǎn)： </p> <p> 一、流量、壓力和溫度等檢測(cè)儀器必須經(jīng)過校驗(yàn)并在校驗(yàn)期內(nèi)； </p> <p> 二、制定詳細(xì)的取樣計(jì)劃、化驗(yàn)方法并得到相關(guān)部門的批準(zhǔn)； </p> <p> 三、性能確認(rèn)時(shí)至少應(yīng)制定好BPR（Batch Production Record，即空白批記錄），四川庫存管理軟件滅菌柜驗(yàn)證第三方，按照方案的要求操作設(shè)備，觀察、調(diào)試和取樣并記錄運(yùn)行參數(shù)； </p> <p> 四、將驗(yàn)證數(shù)據(jù)和結(jié)果直接填入性能確認(rèn)方案的空白記錄部分，或作為其附件。人工記錄和計(jì)算機(jī)打印的數(shù)據(jù)作為原始數(shù)據(jù)，數(shù)據(jù)資料必須注明日期和簽名，四川庫存管理軟件滅菌柜驗(yàn)證第三方，四川庫存管理軟件滅菌柜驗(yàn)證第三方。 </p> <p> <br /> 旦霆科技作為國內(nèi)較早從事儀器設(shè)備驗(yàn)證的公司，專業(yè)提供滅菌柜驗(yàn)證服務(wù)，擁有幾十人的驗(yàn)證團(tuán)隊(duì)，值得信賴！四川庫存管理軟件滅菌柜驗(yàn)證第三方</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="四川庫存管理軟件滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294992236329/5059315.png"></div><p> 驗(yàn)證的概念 </p> <p> 1.2010GMP </p> <p> 驗(yàn)證：證明任何操作規(guī)程（或方法）、生產(chǎn)工藝或系統(tǒng)能夠達(dá)到預(yù)期結(jié)果的一系列活動(dòng)。 </p> <p> 確認(rèn)：證明廠房、設(shè)施、設(shè)備能正確運(yùn)行并可達(dá)到預(yù)期結(jié)果的一系列活動(dòng)。 </p> <p> 2.WHO,GMP </p> <p> 驗(yàn)證：證明任一程序、加工、設(shè)備、物料、活動(dòng)或系統(tǒng)能得到預(yù)期結(jié)果，并且有文件記錄的活動(dòng)。 </p> <p> 3.FDA，GMP </p> <p> 驗(yàn)證：是要有足夠的證據(jù)，能證明這一工序?qū)⑹冀K如一地產(chǎn)生出符合預(yù)定質(zhì)量要求的產(chǎn)品，并把這些證據(jù)形成文字。 </p> <p> 2010 GMP 第七章確認(rèn)與驗(yàn)證 </p> <p> ***百三十八條企業(yè)應(yīng)確定需要進(jìn)行的確認(rèn)或驗(yàn)證工作，以證明有關(guān)操作的關(guān)鍵要素能得到有效控制。確認(rèn)或驗(yàn)證的范圍和程度應(yīng)經(jīng)過風(fēng)險(xiǎn)評(píng)估來確定。 </p> <p> <br /> 上海倉庫管理軟件滅菌柜驗(yàn)證怎么做專業(yè)從事滅菌柜驗(yàn)證、培養(yǎng)箱驗(yàn)證、滅菌隧道驗(yàn)證、GSP冷庫驗(yàn)證、熱風(fēng)循環(huán)烘箱驗(yàn)證等一些列溫度驗(yàn)證服務(wù)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="四川庫存管理軟件滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335294414755860/4492022.png"></div><p> URS容易出現(xiàn)的問題： </p> <p> 使用單位不能提供詳細(xì)具體的URS為設(shè)計(jì)單位作為設(shè)計(jì)依據(jù)； </p> <p> 不能提出劑型、品種、工藝、產(chǎn)品的質(zhì)量標(biāo)準(zhǔn)或相應(yīng)的操作程序； </p> <p> 對(duì)產(chǎn)量、班次、物流控制方面不了解、不專業(yè)和不擅長(zhǎng)； </p> <p> 不能按自身的生產(chǎn)工藝需要向制藥裝備廠商提出具體的GMP要求； </p> <p> 不能把GMP的對(duì)應(yīng)要求做細(xì)化理解，關(guān)鍵節(jié)點(diǎn)把握不準(zhǔn)確。如潔凈度控制、壓差梯度、氣鎖裝置等； </p> <p> 一份編寫良好的URS用戶需求規(guī)范，不僅考慮工藝要求，而且考慮與GMP的符合性以及驗(yàn)證要求。 </p><p> 設(shè)備驗(yàn)證的內(nèi)容。設(shè)備驗(yàn)證一般包括四個(gè)階段，分別為預(yù)確認(rèn)、安裝確認(rèn)、運(yùn)行確認(rèn)和性能確認(rèn)。預(yù)確認(rèn)，即設(shè)計(jì)確認(rèn)，通常指對(duì)待訂購設(shè)備技術(shù)指標(biāo)適用性的審查及對(duì)供應(yīng)廠商的選定；安裝確認(rèn)，主要指機(jī)器設(shè)備安裝后進(jìn)行的各種系統(tǒng)檢查及技術(shù)資料的文件化工作；運(yùn)行確認(rèn)，為證明設(shè)備達(dá)到設(shè)定要求進(jìn)行的運(yùn)行試驗(yàn)；性能確認(rèn)，指模擬試生產(chǎn)，證實(shí)設(shè)備的穩(wěn)定性。 </p> <p> 通過在技術(shù)層面上對(duì)設(shè)備驗(yàn)證和設(shè)備管理的各個(gè)階段的對(duì)比，我們可以發(fā)現(xiàn)，設(shè)備的預(yù)確認(rèn)，即為設(shè)備管理中的前期管理；設(shè)備的安裝確認(rèn)、運(yùn)行確認(rèn)和性能確認(rèn)為設(shè)備管理中的過渡階段。我們?cè)谠O(shè)備管理方面已經(jīng)積累了較多的經(jīng)驗(yàn)，而在設(shè)備驗(yàn)證方面，經(jīng)驗(yàn)則較為缺乏。如此一來，我們就可以結(jié)合設(shè)備管理來規(guī)范設(shè)備驗(yàn)證的工作，同樣，在設(shè)備驗(yàn)證過程中產(chǎn)生的關(guān)于設(shè)備方面的要求，可以用來進(jìn)一步規(guī)范設(shè)備管理方面的工作。下面就針對(duì)設(shè)備驗(yàn)證的各個(gè)階段，結(jié)合設(shè)備管理來進(jìn)行論述。 </p> <p> <br /> 旦霆科技具備新建企業(yè)整場(chǎng)驗(yàn)證及檢測(cè)的實(shí)力，可有效開展設(shè)備驗(yàn)證及相關(guān)驗(yàn)證或檢測(cè)服務(wù)！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="四川庫存管理軟件滅菌柜驗(yàn)證第三方,滅菌柜驗(yàn)證" src="https://tyunfile.71360.com/WaterMark/UploadFile/SHDTSWKJ/637335295189746094/9212985.png"></div><p> 3Q內(nèi)容 </p> <p> 如果是一套完整的儀器(或設(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)(Design Qualification)，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)(Installation Qualification)，確認(rèn)儀器文件、部件及安裝過程。 </p> <p> OQ，運(yùn)行確認(rèn)(Operational Qualification)，確認(rèn)儀器在空轉(zhuǎn)狀態(tài)下，在操作的極限范圍內(nèi)能作正常的運(yùn)轉(zhuǎn)。 </p> <p> PQ，性能確認(rèn)(Performance Qualification)，確認(rèn)儀器載樣運(yùn)行下是否符合標(biāo)準(zhǔn)規(guī)定。 </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，所以本文所提3Q，是指以上IQ(安裝確認(rèn))、OQ(運(yùn)行確認(rèn))、PQ(性能確認(rèn))。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> <br /> 旦霆科技專業(yè)為國內(nèi)制藥行業(yè)提供滅菌柜驗(yàn)證服務(wù)、第三方測(cè)試執(zhí)行以及技術(shù)支持。四川庫存管理軟件滅菌柜驗(yàn)證第三方</p><p style="text-indent:25px">旦霆科技可提供滅菌柜驗(yàn)證等驗(yàn)證服務(wù)。廣納良言，吸取客戶有效意見、致力于為客戶更好的服務(wù)。四川庫存管理軟件滅菌柜驗(yàn)證第三方</p><p> <p> 運(yùn)行確認(rèn)和性能確認(rèn) </p> <p> <br /> </p> <p> 儀器安裝完成后就需要進(jìn)行驗(yàn)收和運(yùn)行，分別與“4Q驗(yàn)證”的運(yùn)行確認(rèn)和性能確認(rèn)相對(duì)應(yīng)。運(yùn)行確認(rèn)也可以看做是安裝確認(rèn)的一部分，因?yàn)橹挥邪惭b正常的情況下，運(yùn)行才能正常。 </p> <p> <br /> </p> <p> 將驗(yàn)收和運(yùn)行放在一起講是因?yàn)閮烧哂泻芏囝愃频牡胤?，首先兩者均有?duì)于儀器的測(cè)試，但測(cè)試的側(cè)重點(diǎn)不一樣，驗(yàn)收是為了運(yùn)行儀器，測(cè)試儀器的基本功能是否正常，運(yùn)行則是為了測(cè)試儀器的性能是否能滿足要求。 </p> <p> <br /> </p> <p> 例如，液相色譜儀二元泵的驗(yàn)收檢查，我們只會(huì)驗(yàn)證泵的耐壓、準(zhǔn)確性和穩(wěn)定性，但是在二元泵的運(yùn)行檢查中我們會(huì)驗(yàn)證泵的梯度準(zhǔn)確性。在檢測(cè)器的驗(yàn)收檢查中我們會(huì)驗(yàn)證紫外檢測(cè)器的基線噪音和基線漂移等，但是在紫外檢測(cè)器的運(yùn)行檢查中我們需要它能檢出某一低濃度的樣品。 </p> <p> <br /> </p> <p> 簡(jiǎn)單來講，驗(yàn)收檢查只是為了確定儀器的基本功能是否正常，軟件及各模塊的功能是否完善，運(yùn)行則是確認(rèn)儀器能否滿足某一方面的需求。這就牽扯到了采購時(shí)的用戶需求文件，在后續(xù)的運(yùn)行驗(yàn)證中，需要做哪些驗(yàn)證，判斷驗(yàn)證是否合格都需要依據(jù)用戶需求文件進(jìn)行，只有滿足了用戶需求，驗(yàn)證才能說達(dá)到了預(yù)期結(jié)果。 </p> <p> <br /> </p> CNAS-GL040:2019豐富了儀器驗(yàn)證的內(nèi)涵，將其推廣到儀器的整個(gè)生命周期，也體現(xiàn)了現(xiàn)代質(zhì)量管理的思維。四川庫存管理軟件滅菌柜驗(yàn)證第三方</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> 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