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Hi all,
We're currently in the midst of a change in our Eto sterilization process. Because it involves a class 3 CE marked device, we will be filing an amendment to our Design Dossier. The new process is being subjected to a 3 lot sterilization validation.
My question is in regards to the exact timing for the regulatory submittal. If each full sterilization load can be validated individually, is it possible to get approval from the notified body to ship saleable product coming out of the first load?
The alternative would be to wait until all 3 loads are completed, the report is received, and then submit to the NB. There is a 45 day review process, so by the time approval is received, there is a lag of several months from a single lot approach. Additionally, any good product sterilized as part of the 3 loads is collecting dust on the shelves while we wait for approval.
Anyone with experience in this matter, please share!
We're currently in the midst of a change in our Eto sterilization process. Because it involves a class 3 CE marked device, we will be filing an amendment to our Design Dossier. The new process is being subjected to a 3 lot sterilization validation.
My question is in regards to the exact timing for the regulatory submittal. If each full sterilization load can be validated individually, is it possible to get approval from the notified body to ship saleable product coming out of the first load?
The alternative would be to wait until all 3 loads are completed, the report is received, and then submit to the NB. There is a 45 day review process, so by the time approval is received, there is a lag of several months from a single lot approach. Additionally, any good product sterilized as part of the 3 loads is collecting dust on the shelves while we wait for approval.
Anyone with experience in this matter, please share!