Validating pharmaceutical systems

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A joint measure of accuracy and precision, on the other hand, directly addresses this [23].Range is an important component that is established based on acceptable behavior of both systematic and random performance characteristics, and robustness defines an operational range of method factors that will be illustrated in a later section.An assay ATP should include a statement of accuracy and precision as exemplified by:“The procedure must be able to accurately and precisely quantify drug substance in film-coated tablets over the range of 70%- 130% of the nominal concentration with accuracy and precision such that reported measurements fall within ± 3% of the true value with at least 95% probability.”By including a probability statement in the ATP, the risk of making ill-advised decisions from results will be controlled.The uncertainty range (± 3%) and probability (95%) are established based on a predetermined acceptable level of risk of making an incorrect decision with the data.In wave 2, a p H screen around the p H identified in wave 1 is performed, and the p H is established.

This is because method performance is fundamentally comprised of both systematic (bias) and random (variance) components.

These are important characteristics to evaluate during method development (and provide an extensive data set for setting method controls) as they lead to an accurate and precise method.

However, these performance characteristics do not speak directly to the risk of making an ill-advised decision based upon the reportable result obtained from the method [22].

In this screen, chromatographic performance is determined across a range of p H, two organic modifiers and several stationary phases.

At the end of wave 1, the organic modifier and column are set.

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