Stratified Sampling – Content Uniformity (CU) / Uniformity of dosage units; Blend Uniformity (BU); – Qvents

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Updated on November 29, 2023

Updated on November 29, 2023

Refer discussions under Questions and Answers on Current Good Manufacturing Practice Regulations | Production and Process Controls (USFDA)
USFDA: Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment (October 2003) – Was withdrawn in August 2013 by FDA
ISPE: Blend Uniformity and Content Uniformity (BUCU) Tools; Process Flow Diagram for Assessment of Blend and Content Uniformity for Process Design and Process Qualification Batches
ISPE: Comparison of Two Relevant Statistical Approaches to Assess Content Uniformity; Also refer Presentation from James K. Drennen, III, Duquesne University, Centre for Pharmaceutical Technology
ISPE: Blend Uniformity and Content Uniformity (BUCU) FAQs
The use of Stratified Sampling of Blend and Dosage units to demonstrate adequacy of mix for Powder Blends (PQRI, December 2002)
Refer Article Recommendations for the Assessment of Blend and Content Uniformity: Modifications to Withdrawn FDA Draft Stratified Sampling Guidance, J. Pharm. Innov. (2015) 10:76-83 (Paid Article)
Refer Article: Assessment of Blend and Content Uniformity. Technical Discussion of Sampling Plans and Application of ASTM E2709/E2810”; J. Pharm. Innov. (2015) 10:84-97 (Paid content)
ASTM E2810-19; Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units (Paid Article)
ASTM E2709-19: Standard Practice for Demonstrating Capability to Comply with an Acceptance Procedure (Paid Article)

Tags : Stratified Sampling, Uniformity of Dosage Units

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