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FDA Guidance - Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production Muhammad Asim Niazi
August 22, 2025OOS results?? fall outside acceptance criteria and trigger ??mandatory investigations??. The process has ??two phases??: initial laboratory assessment for errors, then a full-scale investigation for root cause. The ??quality unit?? evaluates evidence and
Pharma Sources Insight July 2025
