The term OOS results according to the FDA 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. The 17-page guideline follows a clear step-by-step approach in close linkage with 21 CFR 211 on
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FDA: Investigating OOS Test Results for Pharmaceutical Production
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