张明,萧惠来.EMA与我国不同用途制药用水质要求的对比分析[J].药物评价研究,2019,42(5):815-821
EMA与我国不同用途制药用水质要求的对比分析
Comparative analysis of EMA and NMPA in water quality requirements for pharmaceutical uses
投稿时间:2019-02-25  
DOI:10.7501/j.issn.1674-6376.2019.05.002
中文关键词:  欧洲药品管理局(EMA);制药用水;注射用水;纯化水;提取物制备用水;质量要求
英文关键词:European Medicines Agency(EMA);water for pharmaceutical use;water for injections;purified water;water for preparation of extracts;quality requirements
基金项目:
作者单位E-mail
张明 国家药品监督管理局 药品审评中心, 北京 100022  
萧惠来 国家药品监督管理局 药品审评中心, 北京 100022 penglai8051@aliyun.com 
摘要点击次数: 70
全文下载次数: 180
中文摘要:
      欧洲药品管理局(EMA)于2018年11月发布了"制药用水质量指导原则(草案)",详细介绍了在人用、兽用制剂和原料药生产时,不同情况下注射用水的选择。介绍EMA该文件中对不同用途的水质要求,并与国内的相关要求进行对比,期望引起有关各方关注和思考,保障我国制药用水的质量,进而保证药品质量,保护用药者安全。
英文摘要:
      European Medicines Agency (EMA) issued the "Guideline on the quality of water for pharmaceutical use (Draft)" in November 2018. This guideline is intended to provide guidance on the pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products for human and veterinary. This paper describes the quality requirements in detail for different uses of pharmaceutical water in the guideline and compares them with the relevant domestic requirements. It is hoped that all parties concerned will pay attention to and think about it to ensure the quality of pharmaceutical water used in China, thereby ensuring the quality of drugs and protecting the safety of drug users.
HTML  查看全文  查看/发表评论  下载PDF阅读器
关闭
您是第 2275190 位访客
版权所有 天津中草药杂志社 (天津市南开区鞍山西道308号 300193)
Address: 308# An-shan West Road, Nankai District, Tianjin 300193, China
Tel: +86-22-27474913; 23006822 Fax: +86-022-23006822 E-mail:zcy@tiprpress.com
津备案:津ICP备13000267号 互联网药品信息服务资格证书编号:(津)-非经营性-2015-0031