Medical Devices produced during OQ runs. Are they saleable product?

[arios]

Folks,

Assuming a case where you have remnants of unused / untested products manufactured during an OQ run, is it possible to consider such material suitable for sale? if so, under which possible limitations if any. :truce:

Alberto

 

[MIREGMGR]

I'm sure you'd agree, theoretically, no. The process isn't validated until the run is completed and evaluated.

Practically, what's the company's stance on low-likelihood, severe-effect risks? I.e. they market the product, an adverse event occurs involving it, and during the FDA investigation it comes out that the product was not made with a validated process. Plaintiff's lawyer does a happy dance.

 

[arios]

I am bringing this post back to the attention of the Cove members. I will deeply appreciate further inputs, preferably sources of information to inquire more about this issue. i.e. Examples of related 483's, guidance documents, etc

Respectfully
Alberto Rios

 

[yodon]

We had a client facing this same issue. The PQ on one of the systems that was to be validated would have generated a ton of product and, being a startup with limited funds, they didn't want to scrap it. They had a very conservative regulatory manager. I *think* the plan was to quarrantine the product until the test report was written (presumably all the tests passed) then do a risk analysis report justifying why it was safe to use. Note: this was just for a consumable that was used with the device - if that has any bearing.

It just so happens that the company ended up folding (for other reasons) before they could get the product to market so they didn't actually sell any of that product. Nor did they perform the (final) PQ or do the justification analysis so it's not possible to know how that would have gone over.

I think Miregmgr touched on it: do the benefits outweigh the risk?

It's certainly an interesting question and I hope others chime in with any practical experience.

 

[arios]

I would feel less concerned with selling product coming out from a PQ run, since at that stage the tolerance window of process parameters may have already been defined and probably even documented since it happens after the OQ.

I agree with you that this is a decicion that involves risk...as may involve cost as well.

If we have worries with selling out products from a PQ, it would then be more risky if they come from an OQ.

I did a quick sampling of 483's on the FDA data base of Warning letters and could not find any instance of companies being penalized for doing, so, but that does not mean that the risk does not exist.

Thank you all for sharing

 

[somashekar]

I would feel less concerned with selling product coming out from a PQ run, since at that stage the tolerance window of process parameters may have already been defined and probably even documented since it happens after the OQ.

I agree with you that this is a decicion that involves risk...as may involve cost as well.

If we have worries with selling out products from a PQ, it would then be more risky if they come from an OQ.

I did a quick sampling of 483's on the FDA data base of Warning letters and could not find any instance of companies being penalized for doing, so, but that does not mean that the risk does not exist.

Thank you all for sharing

Its all about good risk management and good judgement., coupled with a robust OQ process. Fact is that several lots of an initial run of a PQ goes into the market and manufacturers keep a track of its traceability and see for any early warning if they surface. I wouild also say that many subsequent lots are no different than the PQ lots. I will end by again reitarating the first line ...
Its all about good risk management and good judgement., coupled with a robust OQ process