Apr 22, 2018 · This flow diagram is recommended for the assessment of blend and content uniformity during the manufacture of batches corresponding to Stage 1: Process Design and Stage 2: Process Qualification. The sampling plans presented are meant to be examples.

Blend uniformity should be assessed during process design (Stage 1 Validation) and process qualification (Stage 2 Validation).

This paper describes the ISPE sponsored Blend Uniformity and Content Uniformity Group’s proposed modifications to the withdrawn FDA draft guidance document for industry “Powder Blends and Finished Dosage Units – Stratified In-Process …

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