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Inspections while facilities are on lock down

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Posted 17 June 2020 - 10:52 PM

Is anyone having to either get creative or complete risk assessments on not completing certain inspections that happen on a regular occurrence? (such as GMP, pest control)


And by no means am I saying that they cannot follow procedures or regulations, just that due to limited staff, inspectors are not allowed in the premises, and due to demand there are no extra bodies to do these inspections that are already allowed in the building.




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Posted 18 June 2020 - 12:45 PM

Our company allowed pest control visits to continue, but did not allow office staff out in production areas.  :rolleyes: SO, rather than forego the monthly GMP audit altogether, I had production supervisors perform the audits on their areas.  I figured that I was choosing the lesser of two evils .  I'm crossing my fingers I am allowed to resume regular GMP audits (performed by myself) this month!


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Posted 18 June 2020 - 01:00 PM

I opened a corrective action with "March internal inspection not completed"  (it's the one I missed as I was working from home) as the non-conformance and walked through an explanation of what happened. I don't think any auditor will be caught off guard by issues like this, however I do expect them to ask me how I plan to make sure this doesn't happen again. That's one I am not sure I can answer, or that I am pretty sure the auditor will not agree with my answer..

I did write a summary to corporate that pest control was an essential service to maintain our standards as well as not be in violation of FDA regs, so thankfully they let us maintain that at all of our sites.

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