FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision
Title:
FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision
Origin/Publisher:
FDA
Content:
This guidance for industry provides the Agency’s current thinking on how to evaluate out-ofspecification (OOS) test results