Regulatory Issues
Product Quality Research Institute issues first recommendation to FDA
Published in Medical Letter on the CDC and FDA, May 19th, 2002
The Product Quality Research Institute (PQRI) forwarded its first recommendation to the U.S. Food and Drug Administration (FDA) for review. The recommendation proposes that in-process dosage unit analysis (of tablet cores, hard gelatin capsules or other solid dose forms) be considered as an alternative to routine blend sampling analysis to satisfy the agency's good manufacturing practices (GMP) requirement to demonstrate "adequacy of mixing to assure uniformity and homogeneity."
The recommendation, "The Use of Stratified Sampling of Blend and Dosage Units to Demonstrate Adequacy of Mix for Powder Blends," represents an extensive effort by PQRI's Blend Uniformity...
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