Hi,
I hope you are well
I would like to have your opinion about the qualification of a Fermenter that we have to qualificate.
We would make IQ OQ and PQ ( we will describe this in Validation Plan).
What do you think to do in PQ? … our consulting decided to do only white proof (without product) and sterility proof. Is it enough, Is it correct for you?
Moreover somebody of Quality Assurance team says that these proofs can be put in OQ protocol, so in this sense, this isn’t a real PQ, because it is performed without product.
Do you agree? What do you think about this?
thank you in advance
Regards
Emanuele