Data integrity gmp HPLC Standard Agreement/Concordance check

[djaydearz]

Greetings

Was having a conversation with a peer regarding analysts performing agreement checks prior to their main run, in strict GMP enviornment.

I previously never had a problem with this, particularly as we run overnight, it gives confidence the the main STD agreement check in the SST run will pass before it injects the samples. A quick sequence, to inject them to see if they will pass.

Speaking to this peer however, they deemed some regulatory bodies frown upon this, but couldn't think of a reason why.

Any ideas, or thoughts welcome, thank you

[Multidimensional]

Running formal checks BEFORE and after a batch is always a good idea and allows for early notice of potential problems.

[DR]

You can run all of the standards you want to to establish that your system is equilibrated, and the agencies are generally OK with it so long as they don't show up as part of your "real" run.
Best practice is to label them "equilibration test Std" or something innocuous, keep them in their own separate sequence etc.