ABSTRACT
The specification included in the registration file should be for the quality of drug substance, which is to be used in the manufacture of the drug product. Thus if the drug substance is manufactured by the supplier and then subsequently milled or micronized by a contractor or the drug product manufacturer, the specification should be for the milled or micronized grade. The specification for the intermediate (unmilled) grade should be included in 3.2.S.2.4 Control of Intermediates.
