[ifinnegan]

Eaton added extra blank washes during calibration, but removed them when running analyses on test samples. That meant his analytical methods and systems appeared to be operating properly when they might not have been.

This is crazy that this would be a criminal issue.

There is not enough info to really know what happened.

For example this article does not state if he deviated from the SOP.

If technicians are going to be criminally charged for making mistakes, that is a chilling draconian trend that will not help the pharmaceutical industry at all.

If he was knowingly doing something outside of the SOP purposefully to deliberately manipulate results, that would be fraud and criminal.

But this article doesn't state that and it implies it was criminal because GLP was not compromised.

[expat1000]

Are you suggesting that this could possibly be SOP?

Eaton added extra blank washes during calibration, but removed them when running analyses on test samples.