In late October, ISPE released detailed definitions for the metrics it plans to use in its quality metrics pilot program. Those with consensus industry acceptance are: ● lot acceptance rate ● complaints rate (total and critical) ● confirmed OOS rate, and ● US recall events (total and by class). More metrics are also presented, as well as detailed definitions for how they are defined. [For more on quality metrics see IPQ June 23, 2013.]
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