WHO《制药用水GMP指南》2020草案(中英文对照版)VIP专享VIP免费

1 / 25 Working document QAS/20.842 工作文件QAS/20.842 May 2020 二零二零年五月 DRAFT WORKING DOCUMENT FOR COMMENTS: 征求意见草案: Good manufacturing practices: 优良制造规范（GMP）: water for pharmaceutical use 制药用水 2 / 25 Background 背景 The control of water quality, including microbiological and chemical quality, throughout production, storage and distribution processes is a major concern. Unlike other product and process ingredients, water is usually drawn from an on-demand system and is not subject to testing and batch or lot release prior to use. The assurance of water quality to meet the on-demand expectation is, therefore, essential. 水的制备、存贮和分配过程中对水质的控制，包括微生物和化学质量，是一个重要关注点。与其它产品和工艺成分不同，水通常是来自一个按需运行的系统， 在使用之前不会进行检测，也不会进行批放行，因此确保水质符合所需要求就至关重要了。 In recent years, following extensive consultation with stakeholders, several pharmacopoeias have adopted revised monographs on water for injection (WFI) that allow for production by non-distillation technologies, such as reverse osmosis (RO). In 2017, the World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) recommended that the WHO Secretariat collect feedback on whether or not they should revise the WHO specifications and good manufacturing practices (GMP) on WFI, and how to do so. Following discussions during several consultations, the ECSPP agreed that the monograph in The International Pharmacopoeia (Water for injections) and the guideline WHO Good manufacturing practices: water for pharmaceutical use (1) should both be revised to allow for technologies other than distillation for the production of WFI. In early 2019, the WHO Secretariat...