清洁分组的疑问？？

beiwei5du

这个是关于清洁分组的相关句子，这个是什么意思啊？？

As a general rule, product grouping strategies are not used for newer drugs requiring an NDA. The rationale for this is that companies want their cleaning validation to be as “clean” as possible for any new product.Grouping strategies will be more used for older products in order to bring a facility under compliance as far as cleaning validation is concerned. Some companies will choose, as time allows, to perform an individual cleaning validation on each individual product in a group following the initial validation of the group.

选自：Product Grouping Strategies for Cleaning Validation
http://101.247.67.17:9011/www.cleaningvalidation.com/c3pr90ntc0td/files/98739154.pdf

cnosema

As a general rule, product grouping strategies are not used for newer drugs requiring an NDA. The rationale for this is that companies want their cleaning validation to be as “clean” as possible for any new product.


通常来说，对于需要NDA的较新药品，不会使用清洁分组这一策略。因为，对于任何新产品，厂商都希望他们进行的清洁验证做到尽可能的“干净”。


这个“干净”，个人理解，是没有其它药品的影响（基准线，残留之类的），而进行分组清洁是避免不了其它产品对这个新产品清洁（验证）的影响的。

beiwei5du

cnosema 发表于 2017-8-29 22:12
As a general rule, product grouping strategies are not used for newer drugs requiring an NDA. The ra ...

有一定的道理