WHO公布工艺验证总括指南草案

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MP News

06/07/2016

WHO publishes Draft of an Umbrella Guideline on Process Validation

WHO公布工艺验证总括指南草案

At the end of 2015, the WHO adapted its Appendix 7 to the latest technological standards. Appendix 7 provides support with regard to non-sterile process validation. Now, further changes to WHO guidelines are in sight. One of these changes concerns the guideline on process validation which is currently available as a draft and can be commented on until July, 12th 2016. Please find here an analysis of this draft.

2015年底,WHO采纳了其最近技术标准附录7。附录7为非无菌工艺验证提供了支持。现在,WHO指南有了进一步变化。变化之一是关于工艺验证的指南,现在草案已发布,征求意见截止日期为2016年7月12日

这里是对此草案的一些分析

详细内容见附件

WHO公布工艺验证总括指南草案.doc

  • 宝宝 2016-07-12 08:37
    #1

    GMP的要求越来越严格,原来仅仅在GEP中的内容,也开始被广泛的接受为GMP内容了!