Quality Metric

Lot Acceptance Rate (LAR) in Pharma

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Lot Acceptance Rate (LAR) in Pharma – Formula, Importance, FDA Quality Metrics LOT ACCEPTANCE RATE (LAR) IN PHARMA What is Lot Acceptance Rate? Lot means Batch. Lot Acceptance Rate is percentage of lots (batches) that are accepted and released for distribution out of total lots manufactured in a given period. It is one of the … Read more

Invalidated OOS Rate (IOOSR) in Pharma

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Invalidated OOS Rate (IOOSR) in Pharma – FDA Quality Metrics Explained INVALIDATED OOS RATE (IOOSR) IN PHARMA What is OOS? OOS means Out of Specification. When test result goes outside the approved specification limit, it is called OOS. Example: Assay specification is 95.0% to 105.0%. If result comes 93.2%, it is OOS. OOS can happen … Read more