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


Authors: Thomas de Marchin, Laurent Natalis, Tatsiana Khamiakova, Eric Rozet, Hans Coppenolle

Topics: continued process verification

Vertical: Pharmaceutical

Organizations: Pharmalex, Janssen

Gage R&R studies are often conducted in the industry to determine the operating performance of a measurement system and determine if it is capable to monitor a manufacturing process. Several metrics are commonly associated with Gage R&R studies, such as the precision-to-tolerance ratio (P/T), the precision-to-total-variation ratio (%RR), the Signal to noise ratio (SNR), the %Reproducibility and the %Repeatability. While these metrics may suit well the overall industry, they could be problematic once applied in drug manufacturing sector for several reasons, (1) (bio)pharmaceutical assays are often more variable than common physico-chemical measurement systems and the usual criteria are too restrictive for the pharma industry, (2) analytical methods cannot always be improved once qualified, and (3) measurements are usually costly and time consuming, which makes difficult to have enough data to estimate all sources of variance with high precision.

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