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GUIDANCE DOCUMENT

Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision Guidance for Industry May 2022

Download the Final Guidance Document
Final Level 2 Revised Guidance
Docket Number:
FDA-1998-D-0019
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance for industry provides the Agency’s current thinking on how to evaluate out-of- specification (OOS) test results. For purposes of this document, the term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. The term also applies to all in-process laboratory tests that are outside of established specifications.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1998-D-0019.

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