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Dear all,
Q2(R2) states that "Accuracy should be reported as the mean percent recovery of a known added amount of analyte in the sample or as the difference between the mean and the accepted true value, together with an appropriate 100(1-α) % confidence interval (or justified alternative statistical interval). The observed interval should be compatible with the corresponding accuracy acceptance criteria, unless otherwise justified". The underlined is not in Q2(R1), and seems to be a much more stringent requirement than R1. For example, if the accuracy acceptance criterium is 80 to 120%, then according to R2, the 95% confidence interval should also be within 80 to 120%. Do I understand this correctly?
2) Q14 states that "for most procedures, robustness evaluation is conducted during development. If the evaluation of robustness was already conducted during development, it does not need to be repeated during validation". Does it mean that robustness evaluation should not generally be in the validation report? I guess that is also the reason robustness was moved from Q2 to Q14?
Any insights will be appreciated.