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from the decision rule to cater for such a situation.

As you remember, the proposal is that the limiting quality is set to 85 percent coverage of the 75 to 125 percent label claim interval, and this is the same limiting quality as implied by the draft guidances.  And as you remember, this should be demonstrated for each batch with high confidence.

FDA has commented that a tighter standard may be needed.  We argue that a significantly tighter standard will be problematic.  A standard must be compatible with the capability of products it is regulating.  So it has to be commensurate with the capability of current and pipeline products and with the associated analytical methodology, and in setting that standard, both producer risk and consumer protection should be considered.  If the standard were to exceed capability, that would create difficulties for manufacturing and especially for development and approval of new products and generic versions.

Now I'm going to talk about normal distributions and zero tolerance criterion, also one of the issues raised by the agency.

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