20150617 ECA新闻：WHO公布保存时间研究指南最终版 （分享）

20150617 ECA新闻：WHO公布保存时间研究指南最终版  

GMP News
17/06/2015

WHO publishes final Guideline for Hold-Time Studies

WHO公布保存时间研究指南最终版

After the World Health Organisation (WHO) had released the second draft of the guideline for the design of hold-time studies in March already, it now released the final version as part of the Technical Report Series 992 (TRS 992, Annex 4).

WHO于3月已经公布了保存时间研究指南的第二份草案，现在在992号技术报告里作为附录4公布的是最终版本。

The GMP regulations require that raw materials, packaging materials, intermediate, bulk and finished products need to be stored under suitable conditions. This also includes the definition of maximum hold-times for intermediate and bulk products prior to their further processing. The definition of these times should be justified on the basis of scientific data. This guideline aims at reflecting aspects that may be important in the design of hold-time studies. Active substances and biological products are explicitly excluded. According to WHO, hold-time studies can be part of the development or also be carried out during the later Scale-Ups. In any case they should be confirmed during product validation, though.

GMP法规要求原料、包材、中间体、散装和包装完成的产品均需要在适当条件下存贮。这也包括对中间体和散装产品在进一步处理前的最长保存时间的确定。该时间的定义应基于科学数据进行论证。本指南目是反映保存时间研究中比较重要的方向。活性物质和生物产品不在其中。根据WHO，保存时间可以是研发的一部分，或在后期的放大过程中进行。无论怎样，他们在产品的验证期间必须进行确认。

With coated tablets as an example the guideline demonstrates at what points in the manufacturing process samples can be taken and examined for durability. The number of batches to be examined is supposed to be risk-based. The times, according to which the listed intermediates could be sampled and examined are also mentioned exemplary. Whereas the original draft comprised propositions with regard to combined hold times - meaning the impact of hold times of various intermediates among one another - they are not part of the final guideline any more.

该指南以包衣片作为例子，举例说明了在生产工艺中哪些点可以取样检验其持久性。要检验的批次应根据风险来确定。在其中，还举例提到了在哪些时间可以对中间体进行取样和检验。而原来草案中合并保存时间的说法---即不同中间体的保存时间对另一个的影响---则未在最终指南中出现。

感谢分享！！！！