Setting CU Acceptance Criteria for Larger Sample Sizes
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Soren Andersen, Novo Nordisk  Myron Diener, sanofi aventis  *Gregory L Larner, Pfizer  James Pazdan, Novartis  Lori Pfahler, Merck  Dennis Sandell, Siegfried  Helen Strickland, Glaxo  Kim Vukovinsky, Pfizer 

Keywords: Uniformity of Dosage Units (UDU), Content Uniformity (CU), Specification, Coverage

Process analytical technology applications for content uniformity allow the measurement of significantly more dosage units per batch than required by traditional pharmacopeia testing. Applying the compendial requirements to samples larger than 30 is overly restrictive and leads to a disincentive to take larger samples that would contribute to increased process understanding and control. Sandell (et al) proposed a nonparametric counting test for samples greater than 100 dosage units that provides equal or better assurance of content uniformity than the compendial test. As there may be numerous manufacturing situations that would yield sample sizes of 31 to 99 per batch, this work provides appropriate tests for those moderate sample sizes.