金币
UID190197
帖子
主题
积分4262
注册时间2015-2-25
最后登录1970-1-1
听众
性别保密
|
发表于 2016-11-5 22:27:18
|
显示全部楼层
这是ISPE 关于水的Guideline 上的(volume4,Water and steam Systems, p130-140)
10.3.3 Phase 3
The third phase is intended to demonstrate that, when operated for an extended time period (typically one
year), the system produces and delivers water of the required quality, despite possible seasonal variations of
the feed water. Sample locations, frequencies, and test requirements are based on the established procedures.
For WFI systems, the FDA Guide recommends sampling daily from a minimum of one point of use,
with all points of use tested weekly. At the end of this phase (i.e., after a full year of testing), the validation is
considered completed. In most cases, ongoing monitoring will establish a continuing record of water quality. |
|