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usp藥品質(zhì)量標準ppt課件(留存版)

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【正文】 eofart analytical instruments and ISO 9001 and ISO17025 certified that: ? 我們的標準品開發(fā)實驗室配備先進,通過了 ISO9001認證以及ISO17025實驗室認可: – performs collaborative testing to qualify USP reference material 執(zhí)行 USP標準品的協(xié)作標定 – test samples that were submitted as part of USP Verification Program 對參加 USP認證項目的樣品進行測試 – offer 3rd party testing services such as USPNatural Products Association program 提供第三方測試服務(比如與美國天然產(chǎn)品協(xié)會的合作項目) USPChina Laboratory 美國藥典中華區(qū)分部實驗室 書面標準 ——各論、通則、凡例 ? about 1400 drug substance monographs。 – FDA will always use the pendial method as the “referee test.” USP is “regulatory analytical procedure” FDA總是使用藥典方法作為 “ 仲裁方法 ” 。 QC (12 months) 批準后,分裝、 貼標 及 QC程序 USP Expert Committees review for suitability for use in USP documentary standards (2 weeks) USP專 家委 員 會 審 核 標 準品的適用性 Submit a Reference Standard 提交標準品 ? USP releases about 360 new lots of official Reference Standards yearly USP 每年正式發(fā)行約 360個新批次的標準品 ? Half are brand new to our catalog, and half are replacement lots for existing standards 其中半數(shù)為新加入的標準品,另有一半為現(xiàn)有標準品的更新批次 ? USP appreciates your support on RS candidates USP 歡迎國內(nèi)企業(yè)提供標準品候選樣品 Benefits of Participation 參與對于企業(yè)的利益 ? Direct impact in setting the USP specifications for the donated material/monograph 通過提供樣品和方法直接影響 USP規(guī)格的制定 ? Competitive advantage, because your standard is used and enforced by regulatory authorities 競爭優(yōu)勢,因為您的標準是官方標準并被強制執(zhí)行 ? Public recognition by USP through its Donor Recognition Program 通過 USP質(zhì)量標準合作方認可(表彰)計劃獲得公眾認可 ? Enhanced corporate citizenship image 有助于提高企業(yè)形象 ? Copies of the multilaboratory collaborative testing results with traceability to your reference standard 提供給企業(yè)標準品標定的多實驗室聯(lián)合標定結果和可追溯性說明 Donor Recognition Program USP質(zhì)量標準合作方認可計劃 ? Free workshop registrations 專題學術討論會免費注冊 ? Free print subscription to either USPNF, FCC or DSC 免費印刷版 USPNF, FCC 或 DSC ? Free onsite USP Pharmacopeia Education course 免費現(xiàn)場藥典培訓 ? One year, multiple user license of electronic USPNF 一年多用戶電子版 USPNF ? USP Reference Standards 免費 USP標準品 ? Recognition on the USP Web Site USP官方網(wǎng)站致謝 ? Recognition in the USPNF USPNF出版物致謝 ? USP Annual Science Meeting Recognition USP年度科學大會致謝 Provide RS Candidates to USP 提供標準品給 USP ? Donors will receive USP’s summary data package and a traceability statement after lot release 在批次放行之后,樣品提供者會收到由USP頒發(fā)的樣品聯(lián)合檢測數(shù)據(jù)匯總報告和可追溯性說明 ? Traceability provides link between USP standard and inhouse standard 可追溯性說明為生產(chǎn)廠家提供了 USP標準和生產(chǎn)廠家內(nèi)部標準之間的相關性 USP Certificate USP 證書 C e r t i f i c a t e o f A p p r e c i a t i o n In recognition of YOU for the donation of a plete monograph for [drug or substance name], which may bee an official, public USP standard. USP expresses sincere appreciation to [pany name] for its participation in
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