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

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Updated on October 11, 2023

Updated on October 11, 2023

Refer discussions under Questions and Answers on Current Good Manufacturing Practice Regulations | Production and Process Controls (USFDA)
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
Refer Article Recommendations for the Assessment of Blend and Content Uniformity: Modifications to Withdrawn FDA Draft Stratified Sampling Guidance, J. Pharm.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)

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