Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision

May 16, 2022

Guidance for Industry
May 2022

Today, FDA is announcing revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.” Specifically, this revision updates terminology for consistency with current FDA guidance, e.g., quality control unit is changed to quality unit, as well as clarifies concepts related to addressing outlier results, and practices related to the averaging of OOS results. This guidance provides FDA’s current thinking on how to evaluate OOS test results. For purposes of this guidance document, the term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files, official compendia, or by the manufacturer. The term also applies to all in-process laboratory tests that are outside of established specifications.

Download the Final Guidance Document

Final Level 2    Revised Guidance

Interested in learning more? Contact us today to find out how we can help not only with your EMA/FDA submissions, but all of your global regulatory needs.




ANDA CDER Several filename extensions shown in an array of icons.

June 27, 2022

Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry

Final Guidance June 2022 This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of...

Read the Full Article
CDER FDA Lab technician injecting a substance into a vial in a labratory.

May 31, 2022

Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues

Guidance Document Center for Drug Evaluation and Research This guidance describes the Food and Drug Administration’s (FDA’s) current recommendations regarding the overall development program to...

Read the Full Article
FDA North America A monitoring laboratory with an MRI machine behind the glass.

June 7, 2022

Electromagnetic Compatibility (EMC) of Medical Devices

Guidance Document June 2022 This guidance document provides the FDA’s recommendations on testing to assess the electromagnetic compatibility of medical devices and information to include in the...

Read the Full Article