FAILURE (OUT-OF-SPECIFICATION) OOS LABORATORY RESULTS (USFDA)

FAILURE (OUT-OF-SPECIFICATION) OOS LABORATORY RESULTS (USFDA) Evaluate the company’s system to investigate laboratory test failures (OOS). These investigations represent a key issue in deciding whether a product may be released or rejected and form the basis for retesting, and resampling. In a recent court decision the judge used the term “out-of-specification” (OOS) laboratory result rather …

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