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Test and Control Article Characterization
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Item Number: NWRR4131
A procedure for determining the characteristics of test and control articles. This procedure applies to test and control articles used for nonclinical laboratory studies that support or are intended to support applications for products regulated by the Food and Drug Administration (FDA). This seven-page document assigns responsibility for characterization of test and control articles provided by a commercial supplier, by a sponsor, and by the testing facility laboratory, and for test and control articles prepared by synthesis or other methods.
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