WHO publishes New Version of Guide regarding the Principles of GMP

zhulikou431

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:
1. Pharmaceutical quality system (formerly "quality assurance")
2. Good Manufacturing practices for pharmaceutical products
7. Contract production, analysis and other activities
17. Good practices in quality control
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).
The Guideline "Good Manufacturing Practices for Pharmaceutical Products: Main Principles" has been published as Annex 2 of the Technical Report 986.

zhulikou431

这superordinated指引意见草案已刊登在2013年中期（我们曾报道）。从那时起，一切都没有从根本上改变。只有更改下面的章节已作出：
1，制药质量体系（原名“品质保证”）
医药产品2。良好生产规范
7，合同生产，分析等活动
在质量控制17。良好做法
相对于从2013年的草案中，新的文档中包含药品质量体系的扩展说明。在第一章中，高级管理人员的最终责任已极力强调。同样，资质方面已补充。在第二章中，流程所需的审查已经扩展到科学方面（也是迄今为止唯一审查仅基于经验）。
指引“药品生产质量管理规范的药品：主要原则”已经发表的技术报告986附件2。

山野

英文的，不认识

syhorchid

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