USP修订<1231>制药用水

20151111 ECA新闻：USP修订<1231>制药用水  

GMP News
11/11/2015

USP revises Chapter <1231> onPharmaceutical Water

USP修订<1231>制药用水

Changes to the fundamental monograph onpharmaceutical water <1231> Water for Pharmaceutical Purposes from theUS-American Pharmacopeia have been published for comments in the PharmacopeialForum 41(5). The revision presented in the current draft mainly has astructural nature. The content of the monograph has been reorganised in 9 newchapters which aim at improving readibility and searchability of the contentsearched:

在药典论坛41(5)中，USP公布了基础通论<1231>制药用水的修订草案。修订包括了对结构的改动。通论内容现在重新组织为9个章节，其目的是改善可读性和可搜索性。

1. INTRODUCTION
2. SOURCE WATER CONSIDERATIONS
3. WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
4. VALIDATION AND QUALIFICATION OF WATER PURIFICATION, STORAGE, ANDDISTRIBUTION SYSTEMS
5. DESIGN AND OPERATION OF PURIFIED WATER AND WATER FOR INJECTION SYSTEMS
6. SAMPLING
7. CHEMICAL EVALUATIONS
8. MICROBIAL EVALUATIONS
9. ALERT AND ACTION LEVELS AND SPECIFICATIONS

1.    概述

2.    水源的考虑

3.    药品生产和检测用水

4.    制水、存贮和分配系统确认和验证

5.    纯化水和注射用水设计和运行

6.    取样

7.    化学评估

8.    微生物评估

9.    警戒限和行动限和标准

The draft document is available for freeon the website of the USP Pharmacopeial Forum.You only need to register for free. The deadline for comments is 20 November2015.

文件草案现在可以在网上USP药典论坛中找到。征求意见截止日期为2015年11月20日。

来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272015101110557666/