I have been involved with different organizations where Validation reported
into either Production, Quality and sometimes R&D. Every company is
different when it comes to department definitions and
responsibilities. From my experience, when it comes to areas such as
process/product/cleaning validation, the Process Development area seems to
be a good fit. Especially for new product validations. There's carry over
from PD establishing critical process parameters into the validation
protocol which makes sense. Cleaning issues are also more likely to be
fresh in the minds of professionals when PD is involved/provides input into
the cleaning validation methods.
Computer validation and equipment qualification/validation often find a
different domain within IT or pharma engineering.
Although one can make an argument for or against to have Validation a
function of any one of these departments, PD seems to be the one with the
very few "cons".
I'm curious to read other feedback on this topic.
Regards,
Basil Kayal
Basil_J.Kayal@Roche.com
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