Bracketing for Validation - Processes that share some unitary operations

ifserav

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#1
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
 
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G

Gert Sorensen

#4
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
There is no set way of validating a process, this means that you can define the test that will be the best to prove your process is within control. IF you can define a sequence of teststeps that are generic for your processes and explain why these teststeps are valid at various points in the process then by all means do. You might consider identifying these steps up-front (describe the approach in the VP, and identify the requirements and functionalities in the URS) and then validating them at the first teststep for which they are used.

However, at the very least, I would reference the generic teststep at each of the points where that generic teststep is used in order for an inspector/auditor to be able to follow your entire testsequence and verify the validity of that sequence.

I hope this makes sense to you. :bigwave:
 

v9991

Trusted Information Resource
#5
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.
 
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