SOP to Investigate System Suitability Failure

[Terry]

Dear all,

I am trying to compile an SOP for investigation of lab incidents, includes but not limited to, system suitability failure, calibration out-of-tolerance.

At this point, when we perform this investigation, we refer to our corporate level general investigation procedure. QA guys suggested that QC lab shall have a specific investigation SOP, in addition to OOS investigation SOP, which we already have.

Just want to know what SOP would you refer to when you come across a system suitability failure, QA general SOP or QC specific SOP?

Regards,

Terry

[tom jupille]

Look at your existing general SOP. Ask yourself (and your boss!) what, if anything, you would do differently. Then ask what parts are irrelevant to your situation. Edit as necessary and call it a new SOP.

If the changes are trivial or non-existant, then continue as you are (unless the QA people are annoying you, in which case you copy the old language verbatim to the new SOP).

[Consumer Products Guy]

We don't have a SS failure SOP per se. We have an OOS SOP.

When SS fails (very rare for us), then we have no cGMP data, so no OOS investigation.

[unmgvar]

in HPLC methods most of the SST is done before you reach your samples
at which time you are free to not investigate anything of your results since you still have not run them
create a work flow where the system knows to stop when that part of the SST fails
then there are no samples and so you do not need to really investigate as bad as when samples have been tested.
we do it very nicely using Chromeleon.
safes you a lot of work.
in most of our cases after that the only SST part left to check is the RSD of the STDs in the run.
if it fails from a certain point then we only need to care of those samples that are in the area of the problematic STD. generally at the end of the work.

normally you are not calibrating. what you are doing is verify that the instruments are in spec. if they fail then you rectify and in some cases, calibrate.
here what we do is decide on the amount of rectification the technicians are allowed to perform before what is done is simply re-running until the test passes by luck. of course you can only re-test after you can show that the problem is consistent and that you have a measure to rectify that fits, not simply do a re-run.

[Terry]

Dear dudes,

Thanks very much for you input.

Terry