OOS ( Investigating Out-of-Specification )

            Guidance for Industry

  

Investigating Out-of-Specification (OOS)

               Test Results for    Pharmaceutical Production

 

 

                                           I. INTRODUCTION

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.

This guidance applies to chemistry-based laboratory testing of drugs regulated by CDER. It is

directed toward traditional drug testing and release methods. These laboratory tests are

performed on active pharmaceutical ingredients, excipients and other components, in-process materials, and finished drug products

to the extent that current good manufacturing practice(CGMP) regulations (21 CFR parts 210 and 211)and the Federal Food, Drug, and Cosmetic Act

(the Act) (section 501(a)(2)(B)) apply. The principles in this guidance also apply to in-housetesting of drug product components that are purchased by a firm.

This guidance can also be usedby contract firms performing production and/or laboratory testing responsibilities.Specifically,

the guidance discusses how to investigate OOS test results, including the responsibilities of

 

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