点击Drug Master Files (DMFs) 药品主文件(DMFs),进入如下左侧界面,点击List of DMFs,进入如下右侧界面,可以查看DMF清单,每季度更新一次,DMF活动状态(A=激活;I=没激活)、DMF类型、持有人姓名和主题的变化都包括在内。
点击Drug Master Files (DMFs) 药品主文件(DMFs),进入如下左侧界面,点击List of DMFs,进入如下右侧界面,可以查看DMF清单,每季度更新一次,DMF活动状态(A=激活;I=没激活)、DMF类型、持有人姓名和主题的变化都包括在内。
ANDA(Abbreviation New Drug Application):仿制药或仿制新药申请 API(Active Pharmaceutical Ingredient):原料药或活性药。原简称BPC(Bulk Pharmaceutical Chemical),现常用API。在药典和一些论文中也常用Drug Substance 或Substance 来代表原料药。 Appearance: 外观 Assay:含量 Assessment: 药厂自我评估(厂家组织进行的对药厂...
1. You firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release and your firm failed to establish the accuracy, ...
API(Active Pharmaceutical Ingredient):原料药或活性药。原简称BPC(Bulk Pharmaceutical Chemical),现常用API。在药典和一些论文中也常用Drug Substance 或Substance 来代表原料药。 Appearance: 外观 Assay:含量 Assessment: 药厂自我评估(厂家组织进行的对药厂本身设施有关文件的模拟FDA检...
Food and Drug Administration's (FDA) authority on regulating biopharmaceutical manufacturing. In light of drug recalls from pharmaceutical company Johnson & Johnson and shortages from pharmaceutical company Genzyme Corporation, members from the U.S. House Oversight & Government Reform Committee support ...
近日,FDA发布了2020年度缺陷汇总报告,包含包括药品、生物制品、医疗器械等领域共2788条缺陷,并对缺陷发生频率进行统计,如下: 发布的483数 QC未包括建立科学合理和适当的[规范][标准][取样计划…
API(Active Pharmaceutical Ingredient):原料药或活性药。原简称BPC(BulkPharmaceutical Chemical),现常用API。在药典和一些论文中也常用Drug Substance 或Substance 来代表原料药。 Appearance: 外观 Assay:含量 Assessment: 药厂自我评估(厂家组织进行的对药厂本身设施有关文件的模拟FDA检查) ...
ANDA(Abbreviation New Drug Application):仿制药或仿制新药申请 API(Active Pharmaceutical Ingredient):原料药或活性药。原简称BPC(Bulk Pharmaceutical Chemical),现常用API。在药典和一些论文中也常用Drug Substance 或Substance 来代表原料药。 Appearance: 外观 Assay:含量 Assessment: 药厂自我评估(厂家组织进行的对药厂...
12、。 batches manufactured since last inspection to evaluate any rejections or conversions (i.e., from drug to non-drug use) due to processing problems.对上次检查以后生产的批进行评价是否有不合格品或是由于工艺问题而发生的转变(亦即, 从药物向非药物使用的转变)。 reprocessing and/or reworking event...