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