Keywords
validation
bioassay
quality control
bias
How to Cite
Abstract
The present study was carried out using an alternative approach for validating the potency assay of Oral Polio Vaccine. Owing to the high variability of biological assays, two approaches were utilized to validate the test: the "International Conference on Harmonization" classical approach and the Total Error approach. The main parameters evaluated for the validation study were the trueness, precision and accuracy, seeing that it is a quantitative assay. Also, additional parameters were assessed: the assay adequacy to the acceptance criteria for validation described by the Food and Drug Administration (USA) by determining 20% as the maximum variability, the test reproducibility in a practical approach, using the variance among the potency results of 39 vaccine lots (from the same producer) obtained from the producer laboratory and from the National Control Laboratory, per sample, to calculate the overall geometric coefficient of variation. The Uncertainty of Measurement of Test was also determined. The potency assay has presented good trueness and precision what demonstrated suitable accuracy for the intended use in the two validation approaches.
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