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OOS Investigation

Posted: Thu Dec 21, 2017 12:55 pm
by dempsd2

In a case where it is not possible to undertake retesting in an OOS Phase II investigation as finished product is consumed in the initial sample prep, re-sampling may be justified to provide confidence in the batch. Does re-sampling follow the same rules as retesting i.e. re-sample per validated sampling plan x 5? So for example if the test was Potency and the initial sample size n=5, is re-sampling 5 x n=5 or 25 samples in total?