Demonstration that the alternative procedure meets its performance criteria during validation is not sufficient to imply comparability with the pharmacopoeial procedure. The performance of both procedures must be assessed and compared. Therefore, it is required that the pharmacopoeial procedure is implemented as defined in general chapter 5.26.
The purpose of the comparability study is to evaluate whether the results and performance of an alternative analytical procedure are comparable to those of the pharmacopoeial procedure.
The evaluation typically involves a comparability testing study that generates comparative data followed by statistical evaluation of the test results. When the equivalence as part of the comparability study is accepted, the alternative procedure may be considered statistically equivalent to the pharmacopoeial procedure.
The equivalence testing approach may also be used for biological assays. However, comparability of alternative microbiological methods is covered in general chapter 5.1.6. Alternative methods for control of microbiological quality
If data from two analytical procedures cannot be statistically compared, the conclusion on comparability is based on evidence that the results of the alternative procedure lead to the same unequivocal decision that would be made with the pharmacopoeial procedure, which is also the ultimate goal of the comparability study.
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