Client lacked sufficient knowledge of System Suitability Control (SSC)

  • For assays, scientists develop SSC, to mitigate large assay variability with biologics and vaccine, samples are frequently analyzed in replication over multiple runs, and the mean of all the results is taken as reportable value
  • Variability analysis of these replicates could lead to the detection of assay problem (sample preparation, etc.) but specifications for simultaneous, replicate determinations do not exist to obtain an easy pass / fail decision process
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