By Anonymous on Thursday, March 22, 2001 - 09:43 pm:
Acoording to ICH guidelines on Analytical Method Validation, Ruggedness has to be studied on two different instruments by two different analyst on two different days. But in our lab we have only one Capillary electrophoresis, so we have a problem in demonstrating Ruggedness.
Can any forum members suggest their views.
Thanks
By maris on Friday, March 23, 2001 - 06:26 am:
One of the options is to transfer a study to contract laboratory with acceptable GMP level.
The second one is to use the same instrument with another column (cappilar).
Good luck!
By Anonymous on Tuesday, March 27, 2001 - 07:18 pm:
ICH does not use the term ruggedness. It is only found in the USP, and is falling out of favor. Studies using multiple instruments fall under the topic of precision; specifically intermediate precision and reproducibility. These studies are normally only carried out if the method is to be transfered, used in a collaborative study (in both cases you would have to have multiple instruments), or submitted to the USP.
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