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onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="3jk3p98" class="smallimg"><div><p class="pic"><img src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312264707031/9318208.jpg" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="sw8vktf" class="content"><p><span>需求數量：</span>0</p><p><span>價格要求：</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>產品關鍵詞：</span>甘肅QMS系統(tǒng)驗證GMP咨詢,GMP咨詢</p><p><span>***更新：</span>2021-01-12 07:04:16</p><p><span id="click" >瀏覽次數：0次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="o7ht2mp" 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>網址: </span></p><p><span>手機: </span>021-59882315</p><p><span>地址: </span>上海市青浦區(qū)華徐公路966號法姬娜大廈B323室，325室</p><p>[當前離線] <a rel="nofollow"> [加為商友] </a><a rel="nofollow"> [發(fā)送信件] </a></p></div></div><div id="gpwtv42" class="page-proshow02"><p class="title">詳細說明</p><div id="ir7wynt" class="box"><p><p> 驗證總計劃內容 </p> <p> PIC/S對于GMP咨詢文件中驗證總計劃應包含內容該如何做出具體的指導，指出一個驗證主計劃應包含以下幾方面的資料:1簡介：公司的驗證方針，驗證項目所包含操作的概述，地點和時間安排（包括先后順序）；2如下驗證活動的組織機構：起草VMP，項目負責，驗證工作，報告/文件的控制和準備，文件審批，審核和索引系統(tǒng)，培訓需求管理人員;3工廠/工藝/產品描述：提供對其他文檔的交叉引用。包含或排除驗證的基本原理。對于驗證方法和驗證的范圍應該包括在內;4與其他文件的相互引用關系說明;5特殊工藝說明：簡要說明工廠和工藝的特殊性質和要求;6需驗證的產品/工藝/系統(tǒng)的列表：驗證計劃中的所有驗證活動應以矩陣的形式進行概述和編排，甘肅QMS系統(tǒng)驗證GMP咨詢，包括對驗證所需的程序進行描述，如DQ，IQ，OQ，甘肅QMS系統(tǒng)驗證GMP咨詢，PQ，用于確定工藝和系統(tǒng)的驗證狀態(tài)所用的分析技術的驗證，對驗證方法的概述（如前瞻性驗證，回顧性驗證和再驗證），再驗證活動，產品/工藝/系統(tǒng)當前的驗證狀態(tài)以及驗證安排;7.關鍵合格標準概述：包括第6挑中項目的關鍵合格標準的概述;8.文件格式要求;9.相關的SOP清單;10驗證項目的規(guī)劃和安排：包括驗證所需的人員、設備和其他特殊要求的估計，項目的時間安排，甘肅QMS系統(tǒng)驗證GMP咨詢，子項目的詳細規(guī)劃;11變更控制旦霆科技以高質量、高性價比作為服務宗旨，為國內制藥行業(yè)等眾多行業(yè)提供GMP咨詢及咨詢服務!甘肅QMS系統(tǒng)驗證GMP咨詢</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="甘肅QMS系統(tǒng)驗證GMP咨詢,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312264707031/9318208.jpg"></div><p> 旦霆科技為企業(yè)提供GMP咨詢中發(fā)現驗證過程中儀表校準常見偏差問題如下： </p> <p> 1.新購儀器 /儀表無相應的校準報告或供應商提供的桕關校準記錄2. 儀器 /儀表超過校準日期，尚未校準仍在現場使用，未做任何處置；3. 校準合格儀器/儀表無標識或標識破損、模糊，無法識別； 4.為儀器/儀表出具校準證書的第三方機構資質不全或者資質造假。5．儀器 /儀表精密度不符合要求；6. 需要校準的儀器 /儀表卻未進行校準；7. 校準證書的校準范圍不符合用戶使用需求；甘肅QMS系統(tǒng)驗證GMP咨詢旦霆科技配備幾百套驗證及檢測儀器，專業(yè)的驗證及檢測服務團隊、GMP咨詢，服務區(qū)域覆蓋全國！</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="甘肅QMS系統(tǒng)驗證GMP咨詢,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175311839003906/3223283.jpg"></div><p> 冷鏈運輸系統(tǒng)驗證 </p> <p> 旦霆科技為企業(yè)提供冷鏈運輸系統(tǒng)GMP咨詢冷鏈運輸倉儲物流系統(tǒng)中一般確定為直接影響系統(tǒng)的有：庫房、設施、設備、保溫包裝、運輸工具和監(jiān)控儀器等系統(tǒng)驗證，對于物流系統(tǒng)的風險評估，首先需要確定運輸的環(huán)境，分析運輸過程中可能對產品（藥品或包材）產生的危害，驗證應重點考慮環(huán)境溫度變化、冷藏藥品穩(wěn) 定性數據、運輸或配送的相關信息、包裝部件的設計等。冷鏈運輸車的安裝確認主要是冷藏車的確認，包括制冷系統(tǒng)的安裝，自動控制系統(tǒng)的安裝，以及設備狀態(tài)及關鍵儀表的校準狀態(tài)的確認；運行確認一般在實驗室內完成，這些測試應該能夠保證包裝和運輸方案能夠維持產品所處的內部環(huán)境。測試應該包括冷點和熱點的確認，震蕩測試，受壓測試等。一般包括以下測試項：安裝確認報告以及運行確認方案已完成，冬季、夏季溫度曲線確認，模擬時間曲線（物流流線圖）確認，產品比較大 /**小裝載/季節(jié)測試，溫度比對測試以及按照風險評估結果的其他測試項目；性能測試包括以下內容：確認安裝確認和運行確認已經完成，性能確認方案得到批準，測試儀器儀表校準確認，典型產品裝載按照運輸路線運輸類型、運輸季節(jié)及運輸時間等運輸條件確認，溫度監(jiān)測和計算機系統(tǒng)數據備份的確認。 </p><p> 同步驗證怎么做？ </p> <p> GMP咨詢中，同步驗證是在工藝常規(guī)運行的同時進行的驗證，即從工藝實際運行過程中獲得的數據來確立文件的依據，以證明某項工藝達到預計要求的活動。以水系統(tǒng)驗證為例，人們很難制造一個原水污染變化的環(huán)境條件來考察水系統(tǒng)的處理能力并根據原水污染程度來確定系統(tǒng)運行參數的調控范圍，這種條件下，同步驗證成了合理的選擇。這種情況下，工藝驗證的實際概念是特殊監(jiān)控條件下的試生產，而在試生產性的工藝驗證過程中，可以同時獲得兩方面的結果：一是合格的產品，二是驗證的結果，即“工藝重現性及可靠性”的證據。由于同步驗證與生產同時進行，因此該驗證方式可能帶來產品質量方面的風險，因此，企業(yè)應根據自己的實際情況作出適當的選擇，且在制定驗證方案并實施驗證時，特別注意這種方式的先決條件，分析主客觀的情況并預計驗證結果對保證質量可靠性的風險程度。旦霆科技專業(yè)提供GMP咨詢，服務面向全國，至今為各大制藥企業(yè)、外企、上市公司提供質量服務。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="甘肅QMS系統(tǒng)驗證GMP咨詢,GMP咨詢" src="http://tyunfile.71360.com/UploadFile/SHDTSWKJ/637175312262041015/5554118.jpg"></div><p> 制藥行業(yè)常見生產設備清單 </p> <p> <br /> </p> <p> 我司目前已提供以下常見生產設備GMP咨詢： </p> <p> 無菌制劑：膠塞清洗機，理瓶機，洗瓶機（噴淋式，噴射式，超聲洗滌），隧道烘箱，電熱烘箱，配液系統(tǒng)，灌封機器，凍干機（粉針），粉針分裝機器，軋蓋機，濕熱/敢惹滅菌器 </p> <p> 固體制劑：一步制粒機、濕法制粒機、混合機、膠囊填充機、壓片機、高效包衣機、數粒裝瓶機等 </p> <p> 生物制劑/中藥提取：生物反應器、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> 包裝機械：鋁塑/鋁鋁包裝機、四面封包裝機、全自動包裝線、裝盒機、激光打碼機、貼標機等 </p> <p> <br /> 旦霆科技布局細胞行業(yè)，目前為20余家相關行業(yè)的公司提供GMP咨詢及咨詢等服務。甘肅QMS系統(tǒng)驗證GMP咨詢</p><p style="text-indent:25px">旦霆科技各類行業(yè)的驗證服務經驗，專業(yè)為您提供GMP咨詢，值得信賴！甘肅QMS系統(tǒng)驗證GMP咨詢</p><p> 分析方法驗證的目的是證明所采用的方法達到相應的檢測要求，驗證的內容主要包括準確度、精密度、專屬性、檢測限、定量限、線性、范圍、粗放性（重現性）和耐用性9個方面。某一方法需到底須進行哪些項目的驗證，應根據實際情況而定，一般可分一下3種情況對待：1.對于直接引用有法定依據的方法，如藥典標準和部頒標準，*做系統(tǒng)適用性試驗即可。但若將法定方法用于測定新藥，或將某一品種的法定測定方法用于另一品種，就需進行系統(tǒng)的方法驗證。2.對于已在一實驗室驗證過但需在另一個實驗室使用的分析方法，可采用對照試驗法。即取同一批樣品，按此方法在兩實驗室分別進行檢驗，將結果進行比較(如用t檢驗法計算)，判斷是否有性差異。其他分析方法又分為4種類型，有不同的驗證要求：用于測定原料藥中主要成分或制劑中活性組分(包括防腐劑)的定量分析方法；用于測定原料藥中雜質或制劑中降解產物的分析方法，包括定量分析和限度試驗；用于測定性能特性(如溶解度、溶出度)的分析方法以及鑒別試驗旦霆科技為企業(yè)提供分析方法驗證GMP咨詢。甘肅QMS系統(tǒng)驗證GMP咨詢</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、制藥設備等行業(yè)提供GXP合規(guī)咨詢、驗證服務以及培訓的綜合性咨詢公司； </p> <p> 旦霆公司長期致力于幫助企業(yè)順利通過FDA EU TGA WHO CFDA等機構的GMP認證檢查； </p> <p> 公司成員多來自于**外資制藥企業(yè)、外資GMP咨詢公司、及國內**的第三方檢測公司。 </p> <p> 作為以慈善事業(yè)為使命的旦霆公司堅持以超值的品質為客戶提供服務，同時公司每年利潤的10%捐獻給中國貧困兒童，持久資助中國貧困兒童的教育。 </p></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/2812451.html</p></div></div></div></div></div><div id="cg2v3ks" class="page-right twoColRt"><div id="qk7qgfr" class="box01 margin10 clearfix"><h3><a 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