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
