kisxena
Starting to get Involved
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
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