In November 2016 FDA issued a revision of its guidance on its quality metrics initiative. The revised draft has a voluntary phase that will run into 2018, after this time the program will be mandatory. The revised draft narrows the scope by reducing the number of metrics requested. The FDA calls to provide data for three different primary metrics: lot acceptance rate (LAR), product quality complaint rate (PQCR) and invalidated out-of-specification rate (OOS).
This webcast explains the FDA’s revised draft on submission of quality data and how FDA intends to analyze the data to help develop compliance inspection practices. The role of quality metrics and quality culture implementation programs will be reviewed.