Retired equipment that was never validated

PeterLe

Involved In Discussions
#1
Our engineering group just recently retired a piece of equipment that was currently on our Master Validation Plan gap list. This piece of equipment was making product that never had the software validated. In addition, it was identified that the equipment also needed cleaning validation, which was never conducted. We do not plan on using this equipment again.

My question is from a compliance side, is there something we should do? For example a memo to file stating that the equipment made good product and it has no risk for both cleaning and software?

Also, this piece of equipment did have equipment qualification performed but neither cleaning or software validation was involved in that.

Any advice would be greatly appreciated! Thanks!
 
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dubrizo

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#2
Hi Peter,

I would base this retrospective decision on risk.
-1st stop: Does your QMS give direction on this topic?
-Can you prove to your customer or an auditor that the product which touched that machine is built to Spec/Print and is in no way OOT?
-Are there other cases where validations have been missed or not completed per schedule. This includes software as well as hardware.
-What is your gut saying is the right thing to do in this situation? AKA, the smell test.

My $.02
 

PeterLe

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#3
Hi Dubrizo, I really appreciate your reply. I'll answer your questions below.

1) Our QMS does not give direction on this topic. The only direction is when retiring equipment, it must be calibrated before retirement. This has been completed.

2) The purpose of this equipment was to fill a chamber with solution and also seal the chamber. We do conduct pull testing on the seal on random samples. In addition, we do Bio-Burden testing on samples once a month. The data shows since conducting Bio-Burden testing, the equipment has never failed. We can provide that data if asked.

3) We have a massive gaps in our validation program (which we are addressing via a CAPA). So yes, we have plenty of instances of validation not complete. Luckily we do have a lot of downstream checks that check output. But we have many examples like the one I described above where we are just missing validations of software, cleaning, equipment, etc.

4) I'm being challenged by our engineering group because I responded that if an auditor were to look at the retired equipment and ask to see a software validation or a cleaning validation, we can't provide that. We can provide the equipment qualification was done on this equipment however. My gut is telling me a memo stating that this product was producing acceptable product is the right thing to do. But I have nothing to point to compliance wise to say that writing a memo stating this equipment produced good product through its lifetime. Seems like our engineering group is avoiding work they deem not value added (and I do understand where they are coming from).

To me, in an ideal world, we would at least have a memo stating this equipment produced good product by passing all seal tests and bio-burden testing. Hence the software was operating as designed and it produced clean product. But I'm not sure I can enforce this on our engineering group.

Now that I'm writing this out and based on above, I do believe the risk is actually low. However, there isn't documentation all in one place to retrieve, just in case an auditor were to ask. We can definitely pull the data but it would take some time.

Again, thank you for your helpful reply.
 
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