1. 🧪 Quality & Compliance (Critical for Injectable Sites) KPIDefinitionTargetFrequencyOwnerBatch Rejection Rate% of batches rejected vs total manufactured≤ 0.5%MonthlyQA HeadOOS (Out of Specification)No. of OOS per 1000 tests↓ TrendWeeklyQC HeadOOS Closure TATAvg. days to close OOS≤ 30 daysWeeklyQARight First Time (RFT)% batches released without deviation≥ 98%MonthlyProductionSterility Failure RateFailures in sterility tests0MonthlyMicrobiologyAudit ObservationsNo. of critical/major findings0 …
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