[关键词]
[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。
[Key word]
[Abstract]
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.
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