By K. VdBroeck on Wednesday, August 20, 2003 - 07:53 am:
Hello,
maybe this is not the correct board to post this question but ...
It's generally accepted that if the SST fails you can adjust your operating conditions to meet your SST.I just can't find a reference to a guideline (USP, EP, ICH , ...) that explicitly approves this. I also like to know what is considered as a small modification, since you would not want to revalidate your method.
any help is appreciated
By Anonymous on Wednesday, August 20, 2003 - 08:56 am:
Check USP Pharmocopeial Forum Vol 27(4) [July-August 2001]Pg. 2814 This gives adjustment that are acceptable to methods
By Anonymous on Thursday, August 21, 2003 - 05:42 am:
in the robustnes section of the method validation you should perform small controlled changes to critical parameters like pH, organic content, temp. From these results you can say what is critical and what is not.
By K. VdBroeck on Friday, August 22, 2003 - 01:32 am: