Tag CGMP pharmaceutical testing

Quality Control

How to Handle Out-of-Specification (OOS) Results in Pharmaceutical Manufacturing – A Practical Guide Based on FDA’s 2022 Guidance

Flowchart showing two phases in handling OOS results in pharmaceutical manufacturing based on FDA 2022 guidance: Phase I – Preliminary investigation, Phase II – Full-scale investigation. Includes visual icons of a microscope and test tubes.

Struggling with out-of-specification (OOS) results in pharmaceutical testing? Learn how to handle OOS investigations step-by-step using FDA’s 2022 guidance.

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July 17, 2025