Are my (bio)pharmaceutical assay performances reliable? Only probability of success counts!

Bottles Factory

Alternative to traditional Gage R&R metrics for the pharmaceutical industry

Author(s): Thomas de Marchin (Senior Manager Statistics and Data Sciences at Pharmalex), Laurent Natalis (Associate Director Statistics and Data Sciences at Pharmalex), Tatsiana Khamiakova (Associate Director Manufacturing and Applied Statistics at Janssen), Eric Rozet (Director Statistics and Data Sciences at Pharmalex) and Hans Coppenolle (Director Manufacturing and Applied Statistics at Janssen). This article was originally presented at the conference NCB 2021.

[dt_divider style=”thin” /]

Figure 1: Variability charts as a function of laboratory, day, analyst, device and batch. The three colors refer to three different batches.

Figure 2: Measured value of batches produced. Red horizontal lines: specifications. Green dotted lines: control limits (mean ± 3SD).

Figure 3: Probability of success to be within specification as a function of the batch true value. Vertical red dotted lines: specifications.

Figure 4: Posterior predictive distribution of future measurement as a function of the measuring laboratory. Vertical red dotted lines: specifications.
Scroll to Top