So for developing enzyme products under 13485 which may be used as reagents for IVD (or for use in a step during vaccine manufacturing), what would be the practical difference between verification and validation in general terms?
I think It just dawned on me what the difference between verification and validation is... The terminology threw me off because I was not used to it and my mind it was basically doing the same thing!
It was alluded to by those posting here, but it was just not penetrating because it was so obvious... and something I have done without using such labels for decades...
It seems to be mainly a matter of when!
Verification is in the earlier stage before you finalize the product/process to make sure you are on the right track (and is the primary iterative part). In out case it would be one of the gating factors to scale up to go to the scale-up phase.
Validation is then essentially verifying product to final product specifications and functionality when made under the final "production" conditions/scale.
If validation will be more extensive then teh verification procedure , then verification of paducah at scale may then be done again before the "validation" or as part of it.
Validation and Verification may or may not use the same methods/tests...(use of phase appropriate methods)
Have I finally seen the obvious?
If my understanding now is correct, since we we can verify each batch, we don't need to do process validation just product validation.
In theory the "validation" of our type of products could only be the "verification" of one production scale lot against final product specifications (assuming that includes an activity assay and/or an evaluation of a the performance of a sample by a customer) as the 3 consecutive lot requirement is for process validation.
Doing only one validation batch ups our chances of failed lots, but it would be caught on release testing, so deciding to do more for validation would be purely financially risk based?
Is that right?
It seems to me there are some basic differences between device and pharma development, and although we need to get certified under 13485, what me make is physically closer to pharma in some ways than devices ..
But in other ways it's not like pharma, as what we make will never go directly into a patient , and although it may be used as a reagent in IVD kits, we would not be producing such kits (our customers would be)... and even for kits in some cases it would be a general reagent in some cases and in others it could be an analyte specific reagent...
-Karen