This guidance for industry provides the Agency’s current thinking on how to evaluate out-of-specification (OOS) test results: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision.
This guidance for industry provides the Agency’s current thinking on how to evaluate out-of-specification (OOS) test results: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision.