Good day…
I have a question on validation status of the equipment…(low temperature freezers,incubators,etc.)
Suppose if we have done IQ,IQ and PQ of the equipment and that if it couldn’t be put into immediate use due to some reasons, can we switch off the equipment? Or it should run continuously?
If we are switching it off, do we need to revalidate the equipment before we use even though it remains in the validation period and also the location and other factors remain unchanged???
P.s. u may ask y is it qualified if not be put into immediate use, it was qualified due to some administrative reasons…
No need to requalify the equipment,when bringing it back on line. You might want to redo a empty OR full load 24 hour study when it comes back online, if you feel it could have been damaged for any reason.
Do they have trending (GMP monitoring)? If so, a good middle ground it to review the GMP trend before the shutdown, and after you bring it back up, and show that the trends are similar.
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While you may have commissioned and qualified (IOPQ) the equipment properly, it doesn’t mean centrifuges don’t spin, or autoclaves can’t kill microbes if they are idle… Therefore, before startup be sure all the equipment is properly calibrated and ready to make the drug product. When is the process validation study?
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