Packaging Addition - Non-sterile barrier to protect the whole package

M

MIREGMGR

#11
Worst case is that the pouch doesn't provide a benefit
I'm terminally biased against SBPS systems that differ from industry norm, for exactly the reason that PKOST suggests above: confounded user expectations regarding sterile practice when the outer package isn't the SBPS.

Outreach and inservices are nice. Who will work with the users who don't receive the outreach and aren't at the inservice?

If I were reviewing, I'd say no.

Furthermore...you've identified a product shortcoming, and you're receiving a complaint stream regarding that issue. Are Medwatchs being filed by end users, and are you at risk of FDA concluding that there's an effectiveness issue? My view would be that if you're going to do something about that issue, that something assuredly should fix it. Your argument as presented here doesn't seem to me as if it would be convincing to an FDA inspector.
 
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Elsmar Forum Sponsor
D

deuce64

#12
thanks for this commentary! Gives me food for thought on my approach to this and further to the inspection implications...good thing is that these complaints are essentially 'user inconvenience' and determined not reportable...amounting to about a 0.06% complaint rate...tho trending indicates that a CAPA should be addressing it.
I appreciate everyone's input. thanks!
 

Ronen E

Problem Solver
Staff member
Moderator
#13
MIREGMGR - good points re: 11607. Indeed, we are doing/have done that testing at baseline and have shown no detrimental effects. We also have done the performance testing to show the added benefit in a side-by-side ozone exposure test. As you are aware, there is an aging component of 11607-01 which essentially looks at the seal integrity out at the accelerated (and realtime) age interval. Since we are trying to impart fixes to an increased complaint trend - one that is not visible for months after corrective actions are put into affect - we are approaching the deficiency to the 11607 aging component by justifying that the risks of NOT implementing (i.e. higher user inconvenience rates) is outweighed by the potential benefits that would be acheived through having this pouch. Worst case is that the pouch doesn't provide a benefit, and we have just added labor and materials that are not useful. So that is the angle we're taking on 'regulatorily justifying' the change. To this I ask your's and other's thoughts.
Do you already have a formal (say, ISO 14971 compliant) risk management file in place for this change?
 
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