I,ve got a really important question:
Is it possible tu run concurrent validation based on 3 batches that are not successive?
The problem is that…
our factory manufactures several hundred of batches a year (about 50 different products). But some of the products are a real rarities: 1 (max 2) batches/year.
A year ago I started a concurrent validation of one of them.
And now, since we are producing another batch, I’m trying to continue the validation. Unfortunetely I found out that there was another batch manufactured in the meantime, which I wasn’t aware of (nevermind why).
can I continue this validation, e.g. using Risk Analysis to prove that the overlooked batch “doesn’t matter”.
the validation has to be started all over again, and I will be hunted by Quality Control staff 'till the end of the world
/homogenity test with 5 API’s, each one tested about 30 times = 150 tests:/