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- Posts: 366
- Joined: Wed Feb 02, 2005 9:34 pm
My opinion is that System Suitability determines whether or not a set of data can be reported, but that system suitability does not need to be established before you run a set of samples. For example, if an analyst prepares standards and samples and sets up their sequence - and now it's 5:30 PM and they want to go home - it seems to me perfectly acceptable to let the sequence run and then evaluate the data the following day. And if it turns out that system suitability has failed, then the data will have to be invalidated; and if system suit has passed then the data may be used.
Others in my company firmly believe that system suit has to be shown before the samples are analyzed. So, in the example above our analyst would have to stay untill 8:00PM or could not start the samples untill the following day. I really don't see any logical reason for this. And I've already checked USP <621> and it does not say that system suit has to be evaluated before the samples are run. But it seems that many in the industry do it that way.
I am very interested in hearing feedback from others on this issue.
Thanks