usp藥品質(zhì)量標準ppt課件(編輯修改稿)
2025-02-11 21:03 本頁面
【文章內(nèi)容簡介】 Pharmacopeia Education Courses in China USP藥典培訓課程在中國 USP and FDA in China USP與 FDA在中國 MOU between USP and Official Institutions in China USP與中國官方機構簽署的合作備忘錄 ? Chinese Pharmacopoeia Commission 中國藥典委員會 ? NICPBP/China 中國藥品生物制品檢定所 ? Shanghai Institute for Food and Drug Control 上海市食品藥品檢驗所 ? Beijing Drug Control Institute 北京市藥檢所 ? Zhejiang Drug Control Institute 浙江省食品藥品檢驗所 ? Guangzhou Drug Control Institute 廣州市藥檢所 ? Shandong Drug Control Institute 山東省藥檢所 ? Photo Food MOU Signing MOU Signing Ceremony between USP and NINFS of CDC 中國疾控中心營養(yǎng)與食品安全所與美國藥典會合作備忘錄簽字儀式 MOU between USP and Official Institutions in China USP與中國官方簽署合作備忘錄 USPChina USP中華區(qū)總部 ? Our RS development laboratories are equipped with stateofart 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。 ? 2022 drug product monographs。 ? 360 excipient monographs Example: Pioglitazone Monograph in USP 34 舉例：吡格列酮各論 ,收錄于 USP34 USP標準建立流程 Scientific Liaison performs technical review and drafts the monograph (23 months) 科學 聯(lián)絡 人 進 行技 術審 核，草 擬 各 論 Monograph is received/development initiated 收到各 論 ，啟 動 流程 Monograph is published for public review and ment (3 months) 發(fā) 布各 論 供公眾 評議 Scientific Liaison submits all ments to Expert Committee 科學 聯(lián)絡 人向 專 家委 員 會提交 評議 Expert Committee ballots (12 months) 專 家委 員 會投票 Monograph is published in official publication (USPNF, FCC, etc) (3 months) 各 論 正式 發(fā) 布 Approved Not approved Standards Acquisition 標準收集 ? We identify sponsors that can propose monographs and reference materials to USP for development into standards 確定可以提供分析方法和樣品的發(fā)起方，與 USP合作開發(fā)制定標準 ? Sponsors are pharmaceutical, food, and dietary supplement industries, manufacturers, government, academia 發(fā)起方可以是藥品，食品，膳食補充劑生產(chǎn)企業(yè)，也可以是政府或科研機構 ? Collaborate with the sponsors to get the right information – test methods, validations, etc. – required for standard development 與發(fā)起方合作獲得標準開發(fā)所必需的信息，包括測試方法，驗證數(shù)據(jù)等 Where Are the Monographs Coming From 標準從何而來 ? USP would like to work with more manufacturers from China USP希望與更多中國生產(chǎn)商合作建立標準 Example: Pioglitazone Monograph in PF36（ 1） 舉例：吡格列酮各論 ,收錄于 PF36（ 1） Reference Standard Development 標準品開發(fā) Material is tested and characterized through collaborative testing involving a minimum of three labs—industry, FDA, and USP (3 months) 物料在至少 3個實驗室
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