usp藥品質(zhì)量標(biāo)準(zhǔn)ppt課件-wenkub.com
2025-01-12 21:03 本頁面
【正文】 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 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 歡迎國內(nèi)企業(yè)提供標(biāo)準(zhǔn)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?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 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 專題學(xué)術(shù)討論會(huì)免費(fèi)注冊 ? 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)場藥典培訓(xùn) ? One year, multiple user license of electronic USPNF 一年多用戶電子版 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)合檢測數(shù)據(jù)匯總報(bào)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(biāo)準(zhǔn)和生產(chǎn)廠家內(nèi)部標(biāo)準(zhǔn)之間的相關(guān)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 the public standardssetting process in support of the USP mission: To improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines and food. USP Appreciates Your Contribution USP 感謝您為公眾健康的貢獻(xiàn) Evonik Rexim (Nanning) Pharmaceutical 南寧 贏創(chuàng) 美 詩藥業(yè) 陜西漢江制藥 技源科技（中國）有限公司 Status of Rosidlitazone Monograph 羅格列酮標(biāo)準(zhǔn)開發(fā)狀態(tài) ? USP已經(jīng)收到羅格列酮標(biāo)準(zhǔn)提案 ? USP已經(jīng)收到羅格列酮有關(guān)標(biāo)準(zhǔn)品物料的捐贈(zèng) – 羅格列酮 – 羅格列酮有關(guān)物質(zhì) A – 富馬酸 – 馬來酸 ? 計(jì)劃在 2022年公布提案 做好準(zhǔn) 備 參與 標(biāo) 準(zhǔn) 評(píng) 價(jià)？ ? Identification tests: 鑒別測試 – It is preferred to include two orthogonal tests (IR absorption and HPLC reten
教學(xué)課件相關(guān)推薦
鄂ICP備17016276號(hào)-1