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FOOD AND DRUG ADMINISTRATION - page 84 / 263

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size they consider.  This is sort of a personal opinion.  There's nothing special about two-tier designs.  There's certainly nothing special about the two tiers having one-third on the first tier and two-thirds on the second tier.

And again, this goes back really to a prior comment.  As long as the batch meets the specification of what's an acceptable batch, then any sample size should be acceptable, and this really kind of is going to raise some issues, I guess, that you'll have heard already, and that part I've covered.

The third issue that is raised regarding the FDA proposal, and really a bunch of other proposals, is that by using a test by attributes, again the quality control language, it's making inefficient use of the data.

The fourth issue I wanted to talk about is the zero tolerance criterion.  You've heard that quite a bit already.  I think one of the main points there is that there's really a complete disconnect or conflict, if you will, between having a zero tolerance criterion and allowing variable sample sizes because you're really saying that this is something that you're going to have to fail the larger and larger the sample size gets, even

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