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

Short Title:
Stratified Sampling
Origin/Publisher:

FDA

Content:
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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