K
katastic2908
Please help,
I was hoping someone could help me because trying to search this stuff on the internet is so confusing and most of the time I just end up here anyway.
We are in the midst of qualifying a new sterilization facility, the one we currently use is closing down the location that we use so we are qualifying one of their other locations.
We are in the process of validating and dose mapping, can anyone tell me if I need to notify the FDA somehow? Also for EU, would this be something I would do on a Significant Change Notification to our NB? TIA
I was hoping someone could help me because trying to search this stuff on the internet is so confusing and most of the time I just end up here anyway.
We are in the midst of qualifying a new sterilization facility, the one we currently use is closing down the location that we use so we are qualifying one of their other locations.
We are in the process of validating and dose mapping, can anyone tell me if I need to notify the FDA somehow? Also for EU, would this be something I would do on a Significant Change Notification to our NB? TIA
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