I need some ideas and opinions, we have a bunch of process that share some unitary operations, although some have manual steps and other sutomatic steps, can i validate by unitary operation and avoid a lot of protocols?, any advice.
Thanks in advance.
Sergio ?vila
query could have two perspectives, software-application & product/process.
from a software application perspective, we can build a case for avoiding that specific unit operation being excluded from testing in multiple main functions wherever it is used....
i.e., a sub-function or module being validated once, could be used in multiple operations.(considering that sub-function or module is actually well contained to handle all error scenarios)
from product/process perspective, answer has to be NO.
lets consider an example here... lets consider there is a common bulk, which is being either filled/compressed into different strengths/quantities.
the blending of bulk can be cross referenced, if its a common blend, but the compression/filling process MUST to be demonstrated & validated, as the process parameters, change parts are going to be different.
just by qualifying the unit operation, the need for the establishing/proving the process performance does not really go away. UNLESS you have (more than)-adequate means of proving that the new/current product fits into the qualified ranges!!!.
one argument could be process parameters used for the above strengths/quantities are same as that of qualification, but the change parts have to differ or the , if change parts are same, process parameters would differ....
hope this helps.