Blend Uniformity and Content Uniformity

Technical
Despite introducing modern analytical technology to assess blend uniformity, many companies are still using traditional blend sampling thieves and wet chemistry to assess blend homogeneity. The use of statistically based sampling plans allows variance component analysis to be conducted on both...
Technical
Sampling is the selection of a representative portion of the population to make inferences about the entire population. In pharmaceutical manufacturing, samples are drawn from different stages of the process for both controlling process parameters and assessing drug product quality. In the case of...
Technical
The USP <905> UDU test, widely used for batch release since 2007, is no longer supported by FDA. We propose a two-sided tolerance interval method to alleviate this deficiency. The approach provides 50% confidence and 95% probability that future samples from the batch will conform to USP...
Technical
We propose a method for demonstrating content uniformity in the context of variables sampling and relate this to the acceptance criteria and probability of passing the USP CU test. We demonstrate that a variable sampling plan with 99.4% coverage between 83.5% and 116.5% of label content is...
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Process Flow Diagram for Assessment of Blend and Content Uniformity for Process Design and Process Qualification Batches This flow diagram is recommended for the assessment of blend and content uniformity during the...
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The views presented in this document do not necessarily reflect those of the author’s respective companies or organizations. Furthermore, they should not be interpreted as being representative or endorsed by any...
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Current Events in Blend and Content Uniformity Authors: James Bergum, James Prescott, Ravindra Tejwani, Thomas Garcia, Jon Clark, William Brown This article presents a summary of the stratified sampling session held at...
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In August 2013, the FDA announced the withdrawal of its draft guidance document for industry, Powder Blends and Finished Dosage Units – Stratified In-Process Dosage Unit Sampling and Assessment. The primary reason for...
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Current Activities The Team has submitted two manuscripts for peer review and is awaiting comments: Recommendations for the Assessment of Blend and Content Uniformity. Part 1: Modifications to Withdrawn FDA Draft...