EMA修订了制药用水指南

EMA revises Guide on Pharmaceutical Water

EMA修订了制药用水指南

According to the European Pharmacopoeia, it will be allowed as of the 1st of April 2017 to produce water for injection (WFI) using cold i.e. non-distillation methods (as already reported under "WFI obtained by non-distillation methods - What are the Next Steps?"). Now, the European Medicines Agency (EMA) has published a concept paper on the revision of the Note for Guidance on Quality of water for pharmaceutical use (CPMP/QWP/158/01 EMEA/CVMP/115/01). This Guideline from 2002 describes the different qualities of water for pharmaceutical use and their use in the production of medicinal products and/ or diverse dosage forms (e.g. topical, oral or parenteral). The paper also mentions the production of the different qualities and is in line with the present regulations of the European Pharmacopoeia which only allowed distillation for the production of WFI. The document also describes Highly Purified Water (HPW) and its use. HPW meets WFI quality but can be produced by means of membrane processes. Here, an essential aspect is the proposition of EMA's Quality Working Party  to remove in the future the monograph (1927) Highly Purified Water.

根据欧洲药典计划，自2017年4月1日开始允许使用冷法生产的注射用水（WFI），即非蒸馏法（如已报道的）。现在，EMA已经发布了对“药用水质量指南注释”（CPMP/QWP/158/01 EMEA/CVMP/115/01）的修订版。该2002年的指南描述了制药用水不同质量要求，以及其在药品和/或不同剂型（例如，局部用药、口服或注射用药）生产中的使用。文件还提到不同质量的生产，其与目前EP规定保持一致，EP中过去仅允许采用蒸馏法生产WFI。文件还描述了高纯水（HPW）和其用途。HPW符合WFI质量，但不能采用膜法制备。这里，有一个基本的要求是EMA质量工作组提出未来移除高纯水的各论（1927）。

On EMA's webpage you can find the "Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V)". Comments to this paper can be submitted until 6th June 2017.

在EMA的网页上，你可以找到“制药用水质量指南注释修订所需概念文（H+V）”。对该文件征求意见截止日期为2016年6月6日。