Calculations, including statistical tolerance intervals, can assist in the development and revision of specification acceptance criteria. Manufacturing results for attributes of a biopharmaceutical product can be positively autocorrelated. The sample standard deviation — calculated from limited, positively autocorrelated data — tends to underestimate the long-term process standard deviation (1). In this article, simulated data are used to assess the relative performance of statistical tolerance intervals, intervals calculated using the minimum process performance index Ppk approach, and the sample range. Prevalence…
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