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usp藥品質(zhì)量標(biāo)準(zhǔn)ppt課件(留存版)

  

【正文】 eofart analytical instruments and ISO 9001 and ISO17025 certified that: ? 我們的標(biāo)準(zhǔn)品開(kāi)發(fā)實(shí)驗(yàn)室配備先進(jìn),通過(guò)了 ISO9001認(rèn)證以及ISO17025實(shí)驗(yàn)室認(rèn)可: – performs collaborative testing to qualify USP reference material 執(zhí)行 USP標(biāo)準(zhǔn)品的協(xié)作標(biāo)定 – test samples that were submitted as part of USP Verification Program 對(duì)參加 USP認(rèn)證項(xiàng)目的樣品進(jìn)行測(cè)試 – offer 3rd party testing services such as USPNatural Products Association program 提供第三方測(cè)試服務(wù)(比如與美國(guó)天然產(chǎn)品協(xié)會(huì)的合作項(xiàng)目) USPChina Laboratory 美國(guó)藥典中華區(qū)分部實(shí)驗(yàn)室 書(shū)面標(biāo)準(zhǔn) ——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(zhǔn)后,分裝、 貼標(biāo) 及 QC程序 USP Expert Committees review for suitability for use in USP documentary standards (2 weeks) USP專(zhuān) 家委 員 會(huì) 審 核 標(biāo) 準(zhǔn)品的適用性 Submit a Reference Standard 提交標(biāo)準(zhǔn)品 ? USP releases about 360 new lots of official Reference Standards yearly USP 每年正式發(fā)行約 360個(gè)新批次的標(biāo)準(zhǔn)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(biāo)準(zhǔn)品,另有一半為現(xiàn)有標(biāo)準(zhǔn)品的更新批次 ? USP appreciates your support on RS candidates USP 歡迎國(guó)內(nèi)企業(yè)提供標(biāo)準(zhǔn)品候選樣品 Benefits of Participation 參與對(duì)于企業(yè)的利益 ? Direct impact in setting the USP specifications for the donated material/monograph 通過(guò)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(jìng)爭(zhēng)優(yōu)勢(shì),因?yàn)槟臉?biāo)準(zhǔn)是官方標(biāo)準(zhǔn)并被強(qiáng)制執(zhí)行 ? Public recognition by USP through its Donor Recognition Program 通過(guò) USP質(zhì)量標(biāo)準(zhǔn)合作方認(rèn)可(表彰)計(jì)劃獲得公眾認(rèn)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(biāo)準(zhǔn)品標(biāo)定的多實(shí)驗(yàn)室聯(lián)合標(biāo)定結(jié)果和可追溯性說(shuō)明 Donor Recognition Program USP質(zhì)量標(biāo)準(zhǔn)合作方認(rèn)可計(jì)劃 ? Free workshop registrations 專(zhuān)題學(xué)術(shù)討論會(huì)免費(fèi)注冊(cè) ? Free print subscription to either USPNF, FCC or DSC 免費(fèi)印刷版 USPNF, FCC 或 DSC ? Free onsite USP Pharmacopeia Education course 免費(fèi)現(xiàn)場(chǎng)藥典培訓(xùn) ? One year, multiple user license of electronic USPNF 一年多用戶(hù)電子版 USPNF ? USP Reference Standards 免費(fèi) USP標(biāo)準(zhǔn)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(xué)大會(huì)致謝 Provide RS Candidates to USP 提供標(biāo)準(zhǔn)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(huì)收到由USP頒發(fā)的樣品聯(lián)合檢測(cè)數(shù)據(jù)匯總報(bào)告和可追溯性說(shuō)明 ? Traceability provides link between USP standard and inhouse standard 可追溯性說(shuō)明為生產(chǎn)廠(chǎng)家提供了 USP標(biāo)準(zhǔn)和生產(chǎn)廠(chǎng)家內(nèi)部標(biāo)準(zhǔn)之間的相關(guān)性 USP Certificate USP 證書(shū) 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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