how to make the final batch disposition decision if inconclusive OOS invest.

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It is not unusual for the investigation to be completed and still to be inconclusive as to the reason for the original OOS or OOT value.However the following general advice applies – if the investigation is inconclusive and all re-tests meet specification, the lot may be releasable to make the final batch disposition decision, if:
There are no production aberrations or unusual variationsThe process and product history show that the process is robustThe re-test results are all within known variability for methodThe 95% confidence interval of the overall mean is within specification limitsAll other results from lot (e.g. in-process, content uniformity, dissolution) are consistent with the re-test resultsOther factors such as stability and the use of the product are considered
the paragraph is not from any guidelines, but could be considered in company practices.

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the last paragraph is the most important

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