USP 药品质量标准.pptVIP

* * * * * * 书面标准 ——各论、通则、凡例 about 1400 drug substance monographs; 2000 drug product monographs; 360 excipient monographs Example: Pioglitazone Monograph in USP 34举例：吡格列酮各论,收录于USP34 USP标准建立流程 Scientific Liaison performs technical review and drafts the monograph (2-3 months) 科学联络人进行技术审核，草拟各论 Monograph is received/development initiated 收到各论，启动流程 Monograph is published for public review and comment (3 months) 发布各论供公众评议 Scientific Liaison submits all comments to Expert Committee 科学联络人向专家委员会提交评议 Expert Committee ballots (1-2 months) 专家委员会投票 Monograph is published in official publicatio