Review of alert and action level setting for microbiological cleanroom data

BY DR TIM SANDLE  |  1 MARCH 2023

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Scientific data is concerned with measuring and hence data, whether that is qualitative or quantitative. In pharmaceutical microbiology, this could be a number of cells or colony forming units, a series of growth or no growth results; and incidences of microorganisms. Gathering such data allows for trending and enables control to be achieved.

With microbial numbers, it is a regulatory expectation that alert and action levels be set. Alert and action levels are not specifications - they are ‘snap-shot’ indicators of potential adverse or upward trends, or out-of-control situations. Alert and action levels are used to detect shifts from the norm and to indicate if an individual result or process is potentially out-of-control. Therefore, what is important is the data pattern.