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FDA Powder Blends and Finished Dosage Units-Stratified in Process Dosage Unit Sampling and Assessment

Short Title:
Stratified Sampling


This guidance is intended to assist manufacturers of human drug products in meeting the requirements of 21 CFR 211.110 for demonstrating the adequacy of mixing to ensure uniformity of in-process powder blends and finished dosage units. This guidance describes the procedures for assessing powder mix adequacy, correlating in-process dosage unit test results with powder mix test results, and establishing the initial criteria for control procedures used in routine manufacturing.

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