WHO-GMP将更新，接近于EU-GMP！

GmpForEver

WHO-GMP将更新，接近于EU-GMP！
The current good manufacturing practices (GMP) for pharmaceutical products of the World Health Organisation (WHO) are going to be updated. WHO's GMP main principles are published as Annex 3 in the WHO Technical Report Series, No. 961, from 2011. WHO关于药品的cGMP将要进行更新，WHO-GMP主要原则已于2011年在961号技术报告的附录3中发布
When looking at the proposed changes, it seems that the changes reflect another step towards harmonisation in global GMP standards. Especially the proposed WHO text for chapter 1 on Quality Assurance defines comparable expectations to the new chapter 1 of the EU-GMP Guideline. Both are now having the same title: Pharmaceutical Quality System. The current title of the WHO document is "Quality Assurance". The new document now states that the "pharmaceutical quality system (PQS) can extend to the pharmaceutical development life-cycle stage and should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities". This is almost exactly the same statement which can be found in the EU-GMP chapter 1.
当看了提议的变更后，看起来这些变化反映出全球GMP标准的统一协调化。尤其是质量保证第一章对比欧盟GMP指南第一章，他们有相同的标题：制药质量体系。现在WHO文件里说的是“质量保证”，而要更新的文件说的是“质量质量体系能延伸到药品开发生命循环阶段，应促进革新并持续提高和加强药品开发和生产的联系”。这在EUGMP第一章也有相同的声明Also the emphasis of the senior management's responsibility has been pointed out: "Senior management has the ultimate responsibility to ensure an effective PQS is in place (…) Senior management's leadership and active participation in the PQS is essential. This leadership should ensure the support and commitment of staff at all levels and sites within the organization to the PQS." These can be found in exactly the same words in EU-GMP chapter 1.
对高层管理者职责强调指出：“高层管理者有首要的责任来保证有一个有效的制药质量体系……，高层管理者领导和积极参与制药质量体系中是最基本的要求。领导者应能保证对组织中不同阶层的员工在制药质量体系给予支持和承诺Other comparable requirements are those on the documentation of the QM System. For the first time, there is a requirement in both documents for a Quality Manual, describing the quality management system and the associated responsibilities.
在质量体系部分有其他的对比要求，第一次有了关于质量手册的要求，描述了质量管理系统和相关的职责。Also chapter 7 on contract production and analysis is obviously designed to intensify the control of Contract Acceptors by the Contract Giver and to extend those controls to subcontractors. This is in line with the new EU-GMP chapter 7.
第7章合同生产和检测明显了增强了合同接受者的控制，延伸了这些控制到转包商，这和EU-GMP第7章是一致的Chapter 6 on Quality Control contains only some minor amendments. Here the current draft for a revised chapter 6 of the EU-GMP Guide seems to be a little more precise, providing new requirements on the transfer of analytical methods as well as new regulations about the handling of out-of-specification results.
质量控制第6章也包含了一些小的修订。EU-GMP看起来更细一些，提供了一些方法转移的新要求和OOS处理的新规定。

怀谷

一致的好！

yuansoul

国外一片混乱，这边风景独好

胜利者

谢谢分享

cch986

没有边际啦

youngzhou

谢谢分享         

教授

谢谢分享

厚厚慈悲

发展的必然趋势

豫北风云

来自丁香园的帖子吧？

wang82888

大家都在朝着高要求，严标准的方向努力，相遇是迟早的，这是好事，有发展才有进步。谢谢楼主的分享。

GmpForEver

豫北风云 发表于 2013-2-16 13:09
来自丁香园的帖子吧？

N年不去丁香园了，丁香园可不如这里火爆。不管丁香园有没有，这绝对是我的原创帖，中文是我自己翻译的。所以如果丁香园中有一模一样的帖子，他就侵我权啦！