Memo to File - Failure to Validate

kisxena

Starting to get Involved
#1
Hello:

I have a scenario in which I work in a distribution center that houses medical product in ambient, cold and freezing conditions that is shipped in the US and worldwide.

It was discovered that prior to placing product in their designated locations, the empty warehouse, walk-in cold room and walk-in freezers were not validated in an Empty state. However, they have been validated in Full condition prior to use. This applies to various locations throughout the US. As of July 2018, we have been validating Empty state prior to storing product.

It is not possible to remove the product in order to do an Empty state validation at this point. It was suggested that a equipment/location-specific addendum be written up for each one of the executed Full validations. I am suggesting that a Memo to File be generated to address all Affected Units and their locations were not validated in an Empty state prior to product being stored and that moving forward, all units & locations from July 2018 on would be validated properly. Then attach that memo to each validation in our electronic document management system.

Would my suggestion be acceptable by the FDA & ISO?

Please advise.

Thank you
 

yodon

Forum Moderator
Staff member
Moderator
#2
Is conducting an empty state validation your requirements or is this driven by something else?

Regardless, I would recommend that any part of your remediation efforts include a risk assessment. What is the risk to the product currently stored (and distributed!) from not validating the empty state? If there's no risk then your approach sounds at least justifiable. If there is risk, it may be more difficult to justify.
 

Top