Quality Metrics Data Submission USFDA Guidance| USFDA Guidelines |

The draft guidance for Submission of Quality Metrics data was published in 2016. The Guideline gives details about estimation of quality metrics data, what metrics to report and the frequency.
The organizations submitting the data are covered organizations and products are the covered products. The metrics data include:
1. Lot acceptance rate (LAR)
2. Invalidated OOS rate (IOOSR)
3. Product complaint rate (PCR)
The reports are either submitted as Product Reports or Site Reports, with a tier rating system including top tier, middle tier products and sites.
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