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Hello everyone,
Ok, so I have got little problem that I can't seem to find the solution for.
We have a validated sterilization process where the master product does no longer exist (out of production since a long time..) and we would like to identify a new such master product. We have a good candidate product that we can use.
The current validated uses a PCD which is shown to be more challenging than the old master product, and all current products are adopted into this process.
We use an extreme over-kill cycle for EO but during audits we sometimes get questions about the master product that we do no longer have.
So the question is, can we, without full re-validation, switch the master product to our new candidate. If yes, what steps should we do?
We have the data for the selection of the PCD, if we can show that the new master product is equivalent or easier than the old master product to sterilize, would this fact suffice to make the switch?
Any help here would be highly appreciated!
Ok, so I have got little problem that I can't seem to find the solution for.
We have a validated sterilization process where the master product does no longer exist (out of production since a long time..) and we would like to identify a new such master product. We have a good candidate product that we can use.
The current validated uses a PCD which is shown to be more challenging than the old master product, and all current products are adopted into this process.
We use an extreme over-kill cycle for EO but during audits we sometimes get questions about the master product that we do no longer have.
So the question is, can we, without full re-validation, switch the master product to our new candidate. If yes, what steps should we do?
We have the data for the selection of the PCD, if we can show that the new master product is equivalent or easier than the old master product to sterilize, would this fact suffice to make the switch?
Any help here would be highly appreciated!