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Guidance for Industry
Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) October 2006 Pharmaceutical CGMPs

Contains Nonbinding Recommendations

Guidance for Industry
Investigating Out-of-Specification (OOS) Test Results forPharmaceutical Production

Additional copies are available from: Office of Training and Communication Division of Drug Information HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm

U.S. Department of Health and Human Services Food and Drug Administration Center for DrugEvaluation and Research (CDER) October 2006 Pharmaceutical CGMPs

Contains Nonbinding Recommendations

TABLE OF CONTENTS I. II. III.
A. B.

INTRODUCTION............................................................................................................. 1 BACKGROUND ............................................................................................................... 2IDENTIFYING AND ASSESSING OOS TEST RESULTS — PHASE I: LABORATORY INVESTIGATION ........................................................... 3
Responsibility of the Analyst......................................................................................................... 4 Responsibilities of the Laboratory Supervisor............................................................................ 4

IV.A. B. C.

INVESTIGATING OOS TEST RESULTS — PHASE II: FULL-SCALE OOS INVESTIGATION ................................................... 6
Review of Production..................................................................................................................... 6 Additional LaboratoryTesting..................................................................................................... 7 Reporting Testing Results............................................................................................................. 9

V.
A. B. C.

CONCLUDING THE INVESTIGATION.................................................................... 12
Interpretation of Investigation Results ...................................................................................... 12Cautions ........................................................................................................................................ 14 Field Alert Reports ...................................................................................................................... 14

Contains Nonbinding Recommendations

GUIDANCE FOR INDUSTRY1 Investigating Out-of-Specification (OOS)Test Results for Pharmaceutical Production

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discussan alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

I.

INTRODUCTION

This guidance for industry provides the Agency’s current thinking on how to evaluate out-ofspecification (OOS) test results. For purposes of this document, the termOOS 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. 2 This guidance applies to chemistry-based laboratory testing of drugs regulated by CDER....