20140924 ECA新闻：WHO公布“保存时间”研究新版本草案

20140924 ECA新闻：WHO公布“保存时间”研究新版本草案  

2014-09-24 22:17:10|  分类： ECA新闻

24/09/2014

WHO publishes New Version of the Draft on "Hold-Time" Studies

WHO公布“保存时间”研究新版本草案

The 2nd revision for comment was published already in February this year (we reported). Now, a 3rd version is available - also for comment. The document describes the design of hold-time studies for the determination of time limits which have to be determined according to the generally applicable intermediate and bulk products. This should avoid that the storage of intermediate or bulk products from having any negative influence on their quality or the quality of a finished before processing to the next stage.

WHO今年2月（我们已有报道）已公布了对第2版征求意见稿，现在第3版已经公布----也是征求意见。文件描述了用于制订时长限度的保存时间研究的设计。该时长限度必须根据通常适用的中间体和原料药来制订。应避免中间体和原料药的存贮在用于下一步工艺前对其质量或制剂质量造成不良影响。

Chapter 2 which defines what intermediate and bulk products are has been added. It is now explicitly pointed out that hold-time investigations are part of the process validation. In turn, the reference to retrospective observation has been removed from the current version as well as - fortunately - the incomprehensible paragraph on the ?most probable / worst case approach'.

第2章增加了中间体和原料药的定义。现在其中清楚地指出保存时间调查是工艺验证的一部分。相应地，在本版中删除了对回顾性缺陷的引用，同时删除了---幸运地---关于最可能/最差情形方法的难以理解的段落。

Still, the different stages of production are explained with the example of solid forms. A flow chart for better understanding has been newly added.

在修订版中保留了生产不同阶段的解释，举了一个固体制剂的例子。新增了一个更易理解的流程图。

The second part of the last chapter has been completely revised. In the second version, it contained proposals for hold-times of different process materials (in contradiction with the statement according to which data have to be collected for the determination). The quite vague information about cumulated hold-times has also been removed. Instead, the new version now contains a table with proposals of stages and respective tests that may be considered to certain study times.

最后一章的第二部分已被全部修订。在第二版中，其中包括了不同工艺物料（与收集数据所根据的声明相矛盾）保存时间提议。另外删除了关于累计保存时间的模糊信息，在新版本中现在放进了一个表格，提议了可以考虑作为特定的研究时间的不同阶段和相应的测试。

Revision 3 of the draft can be found in the Members Area.

在会员区可以找到该草案的第3版。

http://zhuyujiao1972.blog.163.com/blog/static/986947272014824101710351/

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