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don't know, decisions that go past just the strict adherence to the test?

DR. HUSSAIN:  Let me try to put another layer of issues here, and I think, as I listened to the presentations, I think it came across as if this is a final test.  I would like to sort of remind the committee that I think as we develop your product, as you go through your validation, all these essentially are addressed.  In routine production, it's not a hypothesis test.  The hypothesis test essentially has occurred in terms of development and validation, and I think the confirmation that you have during routine production is simply making sure you're reproducing your validated products.

Now, going back to sort of the issue, Art, you raised, I think today, for example, when we use a zero tolerance criterion, when we reject a batch or when we accept a batch, often, sometimes, there's no difference in the batch quality.  It was simply a statistical -- even that sort of triggers that, and I think that's the point that was being made.

I think what this proposal does is to enhance the science of manufacturing from a validation

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