kaushal09
☆    

India,
2008-12-09 12:45
(6412 d 00:14 ago)

Posting: # 2898
Views: 2,307
 

 Method validation [Regulatives / Guidelines]

Dear ALL,

During Method validation, re-injection reproducibility fail for continuous two times and than pass. it would be accept or any justification required. please help.

regards,

Kaushal :-)
Geokad
☆    

Canada,
2008-12-09 23:55
(6411 d 13:05 ago)

@ kaushal09
Posting: # 2900
Views: 1,804
 

 Method validation

Dear Kaushal,

❝ it would be accept or any justification required.


it is always a good practice to document the reasoning before repeating any failing evaluation. You can't keep repeating evaluations till they pass without justification even if you don't suspect stability.

Regards, Geokad
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