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

https://www.gmp-compliance.org/files/guidemgr/19287685_L2-OOS (2).pdf

Origin/Publisher:

FDA

Content:
This guidance for industry provides the Agency’s current thinking on how to evaluate out-ofspecification (OOS) test results

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