Action level

An established microbial or particle level that, when exceeded, requires immediate investigation and corrective action. In EU GMP Annex 1, action limits for each cleanroom grade are given in Table 5 for particles and Table 6 for microbes; for water, USP <1231> gives typical action levels. Exceeding an action level does not automatically mean a batch fails, but it does require a documented investigation, an impact assessment on product made during the period, and CAPA.