20141001 ECA新闻：WHO公布新版GMP原则指南

20141001 ECA新闻：WHO公布新版GMP原则指南  

2014-11-07 09:09:05|  分类： ECA新闻|

GMP News
01/10/2014

WHO publishes New Version of Guide regarding the Principles of GMP

WHO公布新版GMP原则指南

The draft for comment of this superordinated Guideline was already published in the middle of 2013 (we reported). Since then, nothing has fundamentally changed. Only changes to the following chapters have been made:

2013年中期已公布了本指南前版指南征求意见草案（我们已报道过）。自那时起，草案没有进行过很大改动，只是对以下章节进行了一些更改。

1. Pharmaceutical quality system (formerly "quality assurance") 药品质量体系（之前为“质量保证”）
2. Good Manufacturing practices for pharmaceutical products 药品GMP
7. Contract production, analysis and other activities 合同生产、分析和其它活动
17. Good practices in quality control 质量控制优良规范

Compared to the draft from 2013, the new document contains an extended description of the pharmaceutical quality system. In Chapter 1, the ultimate responsibility of senior management has been strongly emphasized. Likewise, the aspect of qualification has been complemented. In Chapter 2, the required review of processes has been extended to the scientific aspect (so far only review based on experience only).

与2013年的草案相比，新文件包括了对药品质量体系的深入描述。在第1章中，非常强调了高级管理层的无限责任。同样，也对资质进行了要求。在第2章中，对工艺的审核延伸到了科学角度（到目前为止只是根据经验进行审核）。

The Guideline "Good Manufacturing Practices for Pharmaceutical Products: Main Principles" has been published as Annex 2 of the Technical Report 986.

指南“药品GMP主要原则”已作为第986号技术报告的附录2公布。
来源链接：http://zhuyujiao1972.blog.163.com/blog/static/986947272014107995877/

辛苦辛苦，感谢分享

谢谢分享 楼主辛苦 WHO GMP