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Blend Uniformity Guidance Withdrawn In Face Of PQRI Recommendations

This article was originally published in The Tan Sheet

Executive Summary

FDA has withdrawn a draft guidance that established in-process acceptance criteria related to blend uniformity analysis for certain drugs

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Agency urged to "allow stratified sampling and testing of in-process dosage units to demonstrate blend uniformity in all production batches as an alternative to blend analysis," Product Quality Research Institute announces April 5. PQRI suggests option to satisfy agency's GMP requirement that firms need to demonstrate "adequacy of mixing to assure uniformity and homogeneity." Final proposal was presented to PQRI steering committee in December (1"The Tan Sheet" Dec. 10, 2001, p. 23). FDA will evaluate recommendation, either adopt it or provide scientific explanation why the proposal is lacking, PQRI says...

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