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).
So…
can I continue this validation, e.g. using Risk Analysis to prove that the overlooked batch “doesn’t matter”.
Or…
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:/
it seems as if you have already taken a decision and are trying to justify it.
In my personal opinion, the batches need to be consecutive. As folclore tells, the need for the consecutiveness stems from the early days of validation when companies simply “took out” batches that failed the validation. So, the only way out to (weakly) justify your decision could be to retrieve as much data as possible from the “lost” batch (production documentation, equipment records, analysis of retention samples e.g. for homogenity, etc.) to demonstrate that the missed batch complied with all specifications and only the tests added for validation are missing. In that case the validation would include four batches with a lack of some data for one of them. Hopefully there is no deviation in that batch…
I think risk analysis is not the method of choice, first because you have to make very clear of which risks you are evaluating (risk for the product, for the patient, or for your validation target?), and second because if you use this tool to justify just anything, you are spoiling the credibility of your analysis, which after all, and until backed up statistically, is a personal and subjective view of the risks.
Well, not exactly.
For the moment we decided to produce another batch of the product, and in the nearest future another one. Every validation batch is reported seperately, and in the end I draw up a summary raport.
So I got a couple of weeks to decide what to do.
To be honest, that is exactly my opinion, too.
I’m just looking for the “optimal” (finacially) way to handle this situation.
Since there was no deviation, that was my first idea.
But would pharmaceutical supervision accept this sollution?
