When we are doing PV, what is the real meaning of 3 successful Consecutive batches?
We know that, if there is a failure, we have to re-do it again. But, is it accepted if we run different product between those 3 successful validation batches as 2nd option; below?
1st Meaning.
Run – Product – Result
1___A 1st run___Passed
2___A 2nd run___Passed
3___A 3rd run___Passed
OR 2nd Meaning
Run – Product – Result 1___A 1st run___Passed
2----X other product-------
3----X other product------- 4___A 2nd run___Passed
5----X other product------- 6___A 3rd run____Passed
Both examples are consecutive irrespective of the batches made in between. Process Validation is all about a specific product with its own formulation and process instruction. Hope this will help.
I agree with Odracir, both sequences are acceptable. As you say, the “consecutiveness” requirement is only to avoid “skipping out” failed validation batches, but in my opinion there are a bunch of situations where the consecutiveness may and should be disregarded. For example, it makes more sense to take as validation batches the first, fifth and last batch out of a 10-batch campaign, than three batches in a row, or, for a product with 90% of active ingredient, running a validation with three different batches of the active ingredient regardless if they were manufactured in a row or not.
As in the above case, if during process performance qualification,say B product is taken in after first batch of A product and the settings are different than the A product, do we need to validate for three batches of B product and also two batches of the A product?
