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Outline. IntroductionAction LimitsRelease LimitsFinal ThoughtsSuggested Readings. Introduction. A specification is a list of tests, references to analytical procedures, and appropriate acceptance criteria with numerical limits, ranges, or other criteria for the tests described, which establishes the set of criteria to which a drug substance or drug product or materials at other stages of their manufacture should conform to be considered acceptable for its intended use.FR, 63, No. 110, 6/98,22

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