Not sure I understood the comment, if things can be verified later, why did you validate the process?
Anyway, the second comment is right, you should record the parameters for each part/device/whatever that went through the special process.
Marcelo, I did not know how to ask you this question in another thread so please excuse as it is not directly related to process validation but still ANVISA related question.
The ANVISA regulation says "Manufacturers and the Brazilian Registration Holder must report to the Sistema Nacional de Vigilância Sanitária (SNVS)" and then in RDC 23-2012 only talks about the registration holder. I am confused:
* for a foreign manufacturer who shall report the recall: the Registration Holder, the manufacturer or both ?
* If the registration holder did NOT communicate on time or through the right channel a recall, can the manufacturer being considered as responsible ?
Thanks a lot !